Diabetes in pregnancy: are we providing the best care ... - HQIP
Diabetes in pregnancy: are we providing the best care ... - HQIP
Diabetes in pregnancy: are we providing the best care ... - HQIP
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Confidential Enquiry <strong>in</strong>to Maternal and Child Health<br />
<strong>Diabetes</strong> <strong>in</strong> <strong>pregnancy</strong>:<br />
<strong>are</strong> <strong>we</strong> provid<strong>in</strong>g <strong>the</strong> <strong>best</strong> c<strong>are</strong>?<br />
F<strong>in</strong>d<strong>in</strong>gs of a national enquiry<br />
February 2007<br />
England, Wales and Nor<strong>the</strong>rn Ireland
CEMACH Mission statement<br />
Our aim is to improve <strong>the</strong> health of mo<strong>the</strong>rs, babies and children<br />
by carry<strong>in</strong>g out confi dential enquiries on a nationwide basis and<br />
by widely dissem<strong>in</strong>at<strong>in</strong>g our fi nd<strong>in</strong>gs and recommendations.<br />
Please cite this work as: Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. <strong>Diabetes</strong> <strong>in</strong><br />
Pregnancy: Are <strong>we</strong> provid<strong>in</strong>g <strong>the</strong> <strong>best</strong> c<strong>are</strong>? F<strong>in</strong>d<strong>in</strong>gs of a National Enquiry: England, Wales<br />
and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2007.<br />
This work was funded by <strong>the</strong> National Institute for Cl<strong>in</strong>ical Excellence up to 31 March 2005, by<br />
<strong>the</strong> National Patient Safety Agency from 1 April 2005 and by <strong>the</strong> Department of Health, Social<br />
Services and Public Safety of Nor<strong>the</strong>rn Ireland. The views expressed with<strong>in</strong> this publication <strong>are</strong><br />
those of <strong>the</strong> Confi dential Enquiry <strong>in</strong>to Maternal and Child Health and not necessarily those of<br />
its fund<strong>in</strong>g bodies.<br />
The recommendations conta<strong>in</strong>ed <strong>in</strong> this report represent <strong>the</strong> view of CEMACH, which was<br />
arrived at after a c<strong>are</strong>ful consideration of <strong>the</strong> available evidence. It does not override healthc<strong>are</strong><br />
professionals’ <strong>in</strong>dividual responsibility to make appropriate decisions <strong>in</strong> <strong>the</strong> circumstances of <strong>the</strong><br />
<strong>in</strong>dividual patient, <strong>in</strong> consultation with <strong>the</strong> patient and/or guardian or c<strong>are</strong>r.<br />
Published February 2007 by CEMACH<br />
CEMACH, Chiltern Court, 188 Baker Street, London, NW1 5SD<br />
Tel: 0207 486 1191 Fax: 0207 486 6543<br />
Email: <strong>in</strong>fo@cemach.org.uk Website: www.cemach.org.uk<br />
Designed and produced by Interface. Bristol Tel 0117 923 2235.<br />
ISBN: 978-0-9533536-3-7
Contents<br />
Acknowledgements ...........................................................................iv<br />
Glossary and abbreviations ...............................................................vi<br />
Foreword ...........................................................................................xi<br />
Preface .............................................................................................xii<br />
1. Introduction .................................................................................... 1<br />
2. Key fi nd<strong>in</strong>gs of <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme ..................... 3<br />
3. Summary of recommendations ..................................................... 7<br />
4. Methodology ................................................................................ 10<br />
5. A description of women and babies <strong>in</strong> <strong>the</strong> enquiry ...................... 18<br />
6. Factors associated with poor <strong>pregnancy</strong> outcome<br />
<strong>in</strong> women with type 1 and type 2 diabetes .................................. 25<br />
7. Social and lifestyle issues ........................................................... 32<br />
8. Cl<strong>in</strong>ical c<strong>are</strong> issues: preconception ............................................. 41<br />
9. Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong> ................................................... 50<br />
10. Cl<strong>in</strong>ical governance ................................................................... 64<br />
11. A comparison of type 1 and type 2 diabetes .............................. 72<br />
12. Neonatal c<strong>are</strong> of term babies .................................................... 82<br />
13. Conclusions ............................................................................... 96<br />
Appendices ...................................................................................... 98<br />
iii
Acknowledgements<br />
CEMACH acknowledges with grateful thanks <strong>the</strong> contribution made by Dr Mary Mac<strong>in</strong>tosh, Medical<br />
Director of CEMACH until 30th April 2006, to <strong>the</strong> <strong>Diabetes</strong> Programme s<strong>in</strong>ce its <strong>in</strong>ception <strong>in</strong> 2001.<br />
Editor<br />
Jo Modder, Cl<strong>in</strong>ical Director (Obstetrics)<br />
Authors<br />
• Jo Modder, Cl<strong>in</strong>ical Director (Obstetrics)<br />
• Kate Flem<strong>in</strong>g, Senior Data Analyst (until 8th November 2006)<br />
• Dom<strong>in</strong>ique Acolet, Cl<strong>in</strong>ical Director (Neonatology) – Chapter 12<br />
External commentators<br />
• Kirsty Samuel, Lay Panel Assessor, Yorkshire & Humberside Region<br />
• Sue Roberts, National Cl<strong>in</strong>ical Director for <strong>Diabetes</strong><br />
• Stephen Walk<strong>in</strong>shaw, Chair, CEMACH <strong>Diabetes</strong> Professional Advisory Group<br />
• John Scarpello, Deputy Medical Director, National Patient Safety Agency<br />
• Robert Fraser, Chair, NICE <strong>Diabetes</strong> <strong>in</strong> Pregnancy Guidel<strong>in</strong>e Development Group<br />
• Patricia Hamilton, President, Royal College of Paediatrics and Child Health<br />
Acknowledgements<br />
Thanks <strong>are</strong> due to all maternity unit co-ord<strong>in</strong>ators, cl<strong>in</strong>icians and staff who have contributed <strong>the</strong>ir time<br />
and expertise and without whom this report would not have been possible.<br />
In particular, thanks <strong>are</strong> due to:<br />
• All Panel Assessors for <strong>the</strong>ir extensive and detailed review of medical records dur<strong>in</strong>g panel enquiries<br />
and <strong>the</strong> signifi cant amount of time contributed to panel meet<strong>in</strong>gs.<br />
• All Panel Chairs; for chair<strong>in</strong>g panel enquiries <strong>in</strong> <strong>the</strong>ir region, support<strong>in</strong>g <strong>the</strong> CEMACH Regional<br />
Managers, and contribut<strong>in</strong>g to <strong>the</strong> recommendations of this report.<br />
• All CEMACH Regional Managers and Assistants for liais<strong>in</strong>g with local cl<strong>in</strong>icians, manag<strong>in</strong>g <strong>the</strong> data<br />
collection process, prepar<strong>in</strong>g medical records for review and organis<strong>in</strong>g panel enquiry meet<strong>in</strong>gs.<br />
• Pat Doyle, Head of Department of Epidemiology, London School of Hygiene and Tropical Medic<strong>in</strong>e,<br />
for her advice on <strong>the</strong> statistical analysis of this report.<br />
• Tim Clayton, Medical Statistics Unit, London School of Hygiene and Tropical Medic<strong>in</strong>e,<br />
for <strong>in</strong>dependent statistical review of this report.<br />
• Gillian Hawthorne, Consultant <strong>Diabetes</strong> Physician, Newcastle <strong>Diabetes</strong> Centre, for her contribution<br />
to <strong>the</strong> analysis of enquiry panels’ free text comments.<br />
• Oliver Rackham, Consulant Paediatrician, Arro<strong>we</strong> Park Hospital, for his contribution to <strong>the</strong> analysis<br />
of cause of death of stillbirths and neonatal deaths.<br />
• Chris Wright, Consultant Paediatric Pathologist, Royal Victoria Infi rmary, for his advice regard<strong>in</strong>g<br />
<strong>the</strong> data on post mortem exam<strong>in</strong>ation.<br />
iv
• Members of <strong>the</strong> CEMACH <strong>Diabetes</strong> Professional Advisory Group (chaired by Stephen Walk<strong>in</strong>shaw)<br />
for <strong>the</strong>ir support dur<strong>in</strong>g <strong>the</strong> <strong>Diabetes</strong> Programme, and <strong>in</strong> particular, <strong>the</strong>ir advice on <strong>the</strong> development<br />
of data tools and processes of <strong>the</strong> enquiry, <strong>the</strong> content of this report and <strong>the</strong>ir contribution to <strong>the</strong><br />
recommendations conta<strong>in</strong>ed with<strong>in</strong> this report.<br />
• Members of <strong>the</strong> Neonatal Enquiry Steer<strong>in</strong>g Group for <strong>the</strong>ir contribution to <strong>the</strong> development of<br />
<strong>the</strong> Neonatal Enquiry, <strong>the</strong> content of <strong>the</strong> neonatal chapter, and <strong>the</strong>ir contribution to <strong>the</strong> neonatal<br />
recommendations.<br />
• Peer revie<strong>we</strong>rs of <strong>the</strong> report (Appendix F).<br />
• Rosie Houston, Assistant Projects Manager, for manag<strong>in</strong>g <strong>the</strong> publication of this report.<br />
• Naufi l Alam, Data Analyst; Alison Miller, Programme Director and Midwifery Lead; Shona Golightly,<br />
Director of Research and Development; Richard Congdon, CEMACH Chief Executive; and all o<strong>the</strong>r<br />
staff at CEMACH Central Offi ce for <strong>the</strong>ir support and advice dur<strong>in</strong>g <strong>the</strong> development of this report.<br />
v
Glossary and abbreviations<br />
AC Abdom<strong>in</strong>al circumference<br />
ACE <strong>in</strong>hibitor Angiotens<strong>in</strong>-convert<strong>in</strong>g enzyme <strong>in</strong>hibitor; a class of drugs that reduce peripheral arterial<br />
resistance by <strong>in</strong>activat<strong>in</strong>g an enzyme that converts angiotens<strong>in</strong> I to <strong>the</strong> vasoconstrictor<br />
angiotens<strong>in</strong> II.<br />
Album<strong>in</strong>uria The presence of album<strong>in</strong> <strong>in</strong> <strong>the</strong> ur<strong>in</strong>e, <strong>in</strong>dicat<strong>in</strong>g renal dysfunction<br />
Antenatal The period of time <strong>in</strong> <strong>pregnancy</strong> preced<strong>in</strong>g birth<br />
Antepartum stillbirth Death of a baby before <strong>the</strong> onset of labour<br />
Audit An exam<strong>in</strong>ation or review that establishes <strong>the</strong> extent to which a condition, process,<br />
or performance conforms to predeterm<strong>in</strong>ed standards or criteria<br />
Autolysis Spontaneous dis<strong>in</strong>tegration of cells or tissues by autologous enzymes, as occurs after<br />
death<br />
Black, Asian and O<strong>the</strong>r<br />
m<strong>in</strong>ority ethnic group<br />
Term encompass<strong>in</strong>g Black, Asian, Ch<strong>in</strong>ese and o<strong>the</strong>r ethnic groups as dist<strong>in</strong>ct from<br />
White ethnic orig<strong>in</strong><br />
BM A blood glucose test<strong>in</strong>g strip orig<strong>in</strong>ally made by <strong>the</strong> pharmaceutical company<br />
Boehr<strong>in</strong>ger Mannheim (now Roche). ‘BM’ is often used to describe any non-laboratory<br />
blood glucose test.<br />
BMI Body Mass Index<br />
Body Mass Index The body’s <strong>we</strong>ight <strong>in</strong> kilograms divided by <strong>the</strong> squ<strong>are</strong> of <strong>the</strong> height <strong>in</strong> metres,<br />
used <strong>in</strong> <strong>the</strong> assessment of obesity<br />
Caes<strong>are</strong>an section Surgical abdom<strong>in</strong>al delivery of <strong>the</strong> baby<br />
Caes<strong>are</strong>an section rate The percentage of births that <strong>are</strong> by caes<strong>are</strong>an section<br />
Cardiomegaly Enlargement of <strong>the</strong> heart<br />
Cardiotocograph Graphical representation of electronic monitor<strong>in</strong>g of <strong>the</strong> fetal heart rate and of uter<strong>in</strong>e<br />
contractions. The fetal heart rate is recorded by means of ei<strong>the</strong>r an external ultrasonic<br />
abdom<strong>in</strong>al transducer or a fetal scalp electrode. Uter<strong>in</strong>e contractions <strong>are</strong> recorded by<br />
means of an abdom<strong>in</strong>al pressure transducer.<br />
Case-control study A study that comp<strong>are</strong>s exposure <strong>in</strong> subjects who have a particular outcome with<br />
those who do not<br />
CEMACH Confi dential Enquiry <strong>in</strong>to Maternal and Child Health<br />
Centile Any of <strong>the</strong> 99 numbered po<strong>in</strong>ts that divide an ordered set of scores <strong>in</strong>to 100 parts<br />
each of which conta<strong>in</strong>s one-hundredth of <strong>the</strong> total<br />
Childbear<strong>in</strong>g age Defi ned as 15 to 44 years<br />
CNST Cl<strong>in</strong>ical Negligence Scheme for Trusts<br />
Confidence <strong>in</strong>terval A range of values for which <strong>the</strong>re is a 95% chance that it <strong>in</strong>cludes <strong>the</strong> true value.<br />
Confounder A factor that can br<strong>in</strong>g an alternative explanation to an association observed bet<strong>we</strong>en<br />
an exposure and <strong>the</strong> outcome of <strong>in</strong>terest<br />
Congenital anomaly A physical or biochemical malformation which is present at birth<br />
CTG Cardiotocograph<br />
Early neonatal death Death of a live born baby occurr<strong>in</strong>g less than 7 completed days from <strong>the</strong> time of birth<br />
Diabetic ketoacidosis A state of absolute or relative <strong>in</strong>sul<strong>in</strong> defi ciency characterised by hyperglycaemia,<br />
dehydration, acidosis and ketosis<br />
Diabetic nephropathy Kidney dysfunction or disease occurr<strong>in</strong>g as a result of diabetes<br />
Diabetic ret<strong>in</strong>opathy A complication of diabetes affect<strong>in</strong>g <strong>the</strong> blood vessels <strong>in</strong> <strong>the</strong> ret<strong>in</strong>a at <strong>the</strong> back<br />
of <strong>the</strong> eye, which can affect vision. There may be bleed<strong>in</strong>g from ret<strong>in</strong>al vessels<br />
(non-proliferative ret<strong>in</strong>opathy) or <strong>the</strong> development of new abnormal vessels<br />
(proliferative ret<strong>in</strong>opathy).<br />
DKA Diabetic ketoacidosis<br />
vi
Erb’s palsy Injury to <strong>the</strong> nerve roots of <strong>the</strong> brachial plexus of an arm ma<strong>in</strong>ly related to birth trauma<br />
and lead<strong>in</strong>g to various degrees of <strong>we</strong>akness of <strong>the</strong> affected arm which may resolve<br />
dur<strong>in</strong>g <strong>the</strong> fi rst year of life<br />
EUROCAT European Surveillance of Congenital Anomalies<br />
Fetal growth restriction Evidence of abnormally slow growth of <strong>the</strong> fetus with<strong>in</strong> <strong>the</strong> uterus; ei<strong>the</strong>r estimated<br />
<strong>we</strong>ight or abdom<strong>in</strong>al circumference below <strong>the</strong> 10 th percentile, or slow<strong>in</strong>g growth<br />
velocity of <strong>the</strong> abdom<strong>in</strong>al circumference as measured at a subsequent ultrasound scan.<br />
Fetal surveillance The process of perform<strong>in</strong>g fetal <strong>we</strong>ll be<strong>in</strong>g tests (<strong>the</strong>se may <strong>in</strong>clude ultrasound scans,<br />
fetal and placental Dopplers, biophysical profi les and fetal heart monitor<strong>in</strong>g)<br />
Folic acid A water-soluble vitam<strong>in</strong> <strong>in</strong> <strong>the</strong> B-complex group which helps to prevent fetal neural<br />
tube defect when commenced by <strong>the</strong> mo<strong>the</strong>r before conception<br />
Gestation The time from conception to birth. The duration of gestation is measured from <strong>the</strong><br />
fi rst day of <strong>the</strong> last normal menstrual period<br />
Gestational diabetes Carbohydrate <strong>in</strong>tolerance of vary<strong>in</strong>g severity which is diagnosed <strong>in</strong> <strong>pregnancy</strong> and<br />
resolves after <strong>pregnancy</strong><br />
Glucose electrode Blood glucose measurement us<strong>in</strong>g electrochemical biosensors<br />
Glycaemic control Recommended levels of blood glucose<br />
targets<br />
Glycaemic control test A test that assesses how <strong>we</strong>ll blood glucose levels have been controlled over<br />
a period of time<br />
Glycosylated<br />
haemoglob<strong>in</strong><br />
A test which measures <strong>the</strong> amount of glucose-bound haemoglob<strong>in</strong> and refl ects how<br />
<strong>we</strong>ll <strong>the</strong> blood glucose level has been controlled over <strong>the</strong> previous 2 – 3 months<br />
HbA1c Glycosylated haemoglob<strong>in</strong><br />
High dependency c<strong>are</strong> Criteria for receipt of high-dependency c<strong>are</strong> <strong>are</strong>:<br />
• Receiv<strong>in</strong>g NCPAP for any part of <strong>the</strong> day but not fulfi ll<strong>in</strong>g any<br />
of <strong>the</strong> criteria for <strong>in</strong>tensive c<strong>are</strong><br />
• Below 1000g current <strong>we</strong>ight and not fulfi ll<strong>in</strong>g any of <strong>the</strong> criteria for <strong>in</strong>tensive c<strong>are</strong><br />
• Receiv<strong>in</strong>g p<strong>are</strong>nteral nutrition<br />
• Hav<strong>in</strong>g convulsions<br />
• Receiv<strong>in</strong>g oxygen <strong>the</strong>rapy and below 1500g current <strong>we</strong>ight<br />
• Requir<strong>in</strong>g treatment for neonatal abst<strong>in</strong>ence syndrome<br />
• Requir<strong>in</strong>g specifi c procedures that do not fulfi l any criteria for <strong>in</strong>tensive c<strong>are</strong>:<br />
• C<strong>are</strong> of <strong>in</strong>tra-arterial ca<strong>the</strong>ter or chest dra<strong>in</strong><br />
• Partial exchange transfusion<br />
• Tracheostomy c<strong>are</strong> until supervised by a p<strong>are</strong>nt<br />
• Requir<strong>in</strong>g frequent stimulation for severe apnoea.<br />
(British Association of Per<strong>in</strong>atal Medic<strong>in</strong>e, 2001)<br />
Home blood glucose<br />
monitor<strong>in</strong>g (HBGM)<br />
Self-monitor<strong>in</strong>g by <strong>the</strong> patient of blood glucose levels on a regular basis outside<br />
<strong>the</strong> hospital sett<strong>in</strong>g, us<strong>in</strong>g a blood glucose meter<br />
Hyperplasia An abnormal <strong>in</strong>crease <strong>in</strong> <strong>the</strong> number of normal cells <strong>in</strong> normal arrangement<br />
<strong>in</strong> an organ or tissue, which <strong>in</strong>creases its volume<br />
Hypertension High blood pressure<br />
Hypoglycaemia Low blood glucose level<br />
Hypo<strong>the</strong>rmia Abnormally low body temperature<br />
Hypothyroidism Defi ciency of thyroid gland activity which leads to <strong>in</strong>suffi cient production<br />
of thyroid hormones<br />
Induction of labour The process of attempt<strong>in</strong>g to start labour (see spontaneous labour).<br />
A comb<strong>in</strong>ation of pharmacological and physical methods may be used<br />
vii
Glossary and abbreviations<br />
Infant formula An <strong>in</strong>dustrially produced milk product based on cow or soy milk, which aims<br />
to duplicate <strong>the</strong> nutrient content of natural human breast milk<br />
Intensive c<strong>are</strong> Criteria for receipt of <strong>in</strong>tensive c<strong>are</strong> <strong>are</strong>:<br />
• Receiv<strong>in</strong>g any respiratory support via a tracheal tube and <strong>in</strong> <strong>the</strong> fi rst 24 hours<br />
after its withdrawal<br />
• Receiv<strong>in</strong>g NCPAP for any part of <strong>the</strong> day and less than 5 days old<br />
• Below 1000g current <strong>we</strong>ight and receiv<strong>in</strong>g NCPAP for any part of <strong>the</strong> day and<br />
for 24 hours after withdrawal<br />
• Less than 29 <strong>we</strong>eks of gestational age and less than 48 hours old<br />
• Requir<strong>in</strong>g major emergency surgery, for <strong>the</strong> preoperative period and<br />
postoperatively for 24 hours<br />
• Requir<strong>in</strong>g complex cl<strong>in</strong>ical procedures:<br />
• Full exchange transfusion<br />
• Peritoneal dialysis<br />
• Infusion of <strong>in</strong>otrope, pulmonary vasodilator or prostagland<strong>in</strong> and<br />
for 24 hours afterwards.<br />
• Any o<strong>the</strong>r very unstable baby considered by <strong>the</strong> nurse-<strong>in</strong>-charge<br />
to need one-to-one nurs<strong>in</strong>g<br />
• A baby on <strong>the</strong> day of death.<br />
(British Association of Per<strong>in</strong>atal Medic<strong>in</strong>e, 2001)<br />
Interquartile range (IQR) The spread of a set of values bet<strong>we</strong>en which 25% (25th centile) and 75%<br />
(75th centile) of <strong>the</strong>se values lie<br />
Intrauter<strong>in</strong>e death Death of <strong>the</strong> fetus with<strong>in</strong> <strong>the</strong> uterus before delivery<br />
IUD Intrauter<strong>in</strong>e death<br />
Late fetal loss A death occurr<strong>in</strong>g bet<strong>we</strong>en 20 <strong>we</strong>eks + 0 days and 23 <strong>we</strong>eks + 6 days<br />
Late neonatal death Death of a live born baby occurr<strong>in</strong>g from 7 completed days from <strong>the</strong> time of birth<br />
and before 28 completed days after birth.<br />
Legal abortion In England and Wales, term used to describe <strong>the</strong> deliberate end<strong>in</strong>g of a <strong>pregnancy</strong>,<br />
under <strong>the</strong> provisions of <strong>the</strong> current law (1967/92 Act of Parliament), with <strong>the</strong> <strong>in</strong>tention<br />
that <strong>the</strong> fetus will not survive<br />
Macrosomia Oversized baby as seen for example as a consequence of <strong>the</strong> effect of diabetes dur<strong>in</strong>g<br />
<strong>pregnancy</strong>. Defi ned as hav<strong>in</strong>g a birth <strong>we</strong>ight above <strong>the</strong> 90th centile for gestation or<br />
a birth <strong>we</strong>ight of 4000g or more.<br />
Median The value of <strong>the</strong> middle item of a series when <strong>the</strong> items <strong>are</strong> arranged <strong>in</strong> numerical order<br />
Metform<strong>in</strong> An oral antidiabetic agent that decreases glucose production by <strong>the</strong> liver and lo<strong>we</strong>rs<br />
plasma glucose levels<br />
Microalbum<strong>in</strong>uria A very small <strong>in</strong>crease <strong>in</strong> ur<strong>in</strong>ary album<strong>in</strong><br />
Miscarriage Spontaneous end<strong>in</strong>g of a <strong>pregnancy</strong> before viability (currently taken as 24 <strong>we</strong>eks<br />
of gestation)<br />
MODY Maturity onset diabetes of <strong>the</strong> young. A group of autosomal dom<strong>in</strong>ant disorders <strong>in</strong><br />
young people each caused by a s<strong>in</strong>gle gene defect, associated with decreased <strong>in</strong>sul<strong>in</strong><br />
production and vary<strong>in</strong>g degrees of cl<strong>in</strong>ical severity<br />
Multidiscipl<strong>in</strong>ary cl<strong>in</strong>ic A cl<strong>in</strong>ic with access to c<strong>are</strong> from health professionals <strong>in</strong> more than one discipl<strong>in</strong>e.<br />
For diabetes, <strong>the</strong> discipl<strong>in</strong>es recommended <strong>are</strong> obstetrics, diabetology, nurs<strong>in</strong>g,<br />
midwifery and dietetics.<br />
Multiparous A woman who has had at least one previous birth (from 24 <strong>we</strong>eks onwards)<br />
Multiple birth Birth of more than one baby from a <strong>pregnancy</strong><br />
Neonatal death Death of a live born baby before 28 completed days after birth<br />
viii
Neonatal unit A unit which provides additional c<strong>are</strong> for babies over and above that which can be<br />
offered on a postnatal ward or transitional c<strong>are</strong> unit. There <strong>are</strong> different levels of<br />
complexity of c<strong>are</strong> which can be offered by an <strong>in</strong>dividual neonatal unit<br />
Neural tube defect A major birth defect caused by abnormal development of <strong>the</strong> neural tube, <strong>the</strong> structure<br />
present dur<strong>in</strong>g embryonic life which later gives rise to <strong>the</strong> central nervous system (bra<strong>in</strong><br />
and sp<strong>in</strong>al cord)<br />
NHSLA National Health Service Litigation Authority<br />
NICE National Institute for Health and Cl<strong>in</strong>ical Excellence<br />
NSF National Service Framework<br />
Obesity Increased body <strong>we</strong>ight, defi ned as a Body Mass Index of 30 or greater<br />
Odds ratio A measure of <strong>the</strong> excess risk or degree of protection given by exposure to a certa<strong>in</strong><br />
factor. An odds ratio of greater than 1 shows an <strong>in</strong>creased risk and less than 1 shows<br />
a protective effect<br />
Offspr<strong>in</strong>g Term encompass<strong>in</strong>g live births, <strong>in</strong> utero losses after 20 completed <strong>we</strong>eks of gestation<br />
and term<strong>in</strong>ations of <strong>pregnancy</strong> for congenital anomaly<br />
Parity The number of viable <strong>in</strong>fants that a woman has delivered. Viability is currently accepted<br />
from 24 <strong>we</strong>eks of gestation onwards<br />
Per<strong>in</strong>atal mortality rate The number of stillbirths and early neonatal deaths per 1000 live and stillbirths<br />
Placental <strong>in</strong>sufficiency Impairment of placental blood fl ow lead<strong>in</strong>g to impaired fetal growth and nutrition<br />
Post-mortem Exam<strong>in</strong>ation of <strong>the</strong> body after death to determ<strong>in</strong>e cause of death<br />
exam<strong>in</strong>ation<br />
Postnatal The period of time occurr<strong>in</strong>g after birth<br />
Preconception c<strong>are</strong> Counsell<strong>in</strong>g and cl<strong>in</strong>ical management strategies before conception to ensure that<br />
women <strong>are</strong> <strong>we</strong>ll prep<strong>are</strong>d for <strong>pregnancy</strong>. For women with diabetes, this <strong>in</strong>cludes<br />
ensur<strong>in</strong>g near-normal glycaemic control before conception, commenc<strong>in</strong>g high dose folic<br />
acid, review<strong>in</strong>g medication, screen<strong>in</strong>g for diabetes complications, and giv<strong>in</strong>g <strong>in</strong>formation<br />
about <strong>pregnancy</strong> risks, appropriate diet and lifestyle.<br />
Preterm delivery Delivery before 37+0 <strong>we</strong>eks’ gestation<br />
Preterm delivery rate Percentage of all deliveries that occur before 37 + 0 <strong>we</strong>eks’ gestation<br />
Prevalence The proportion of <strong>in</strong>dividuals <strong>in</strong> a population hav<strong>in</strong>g a disease<br />
Primary c<strong>are</strong> The health services that play a central role <strong>in</strong> <strong>the</strong> local community, such as general<br />
practitioners, health visitors, pharmacists, dentists and midwives<br />
Primigravida A woman who is <strong>in</strong> her fi rst <strong>pregnancy</strong><br />
QDS Quarter die sumendum (Lat<strong>in</strong>) mean<strong>in</strong>g four times a day<br />
Qu<strong>in</strong>tile The portion of a frequency distribution conta<strong>in</strong><strong>in</strong>g one fi fth of <strong>the</strong> total sample<br />
Range The difference or <strong>in</strong>terval bet<strong>we</strong>en <strong>the</strong> smallest and largest values <strong>in</strong> a frequency<br />
distribution<br />
Ret<strong>in</strong>al assessment Exam<strong>in</strong><strong>in</strong>g <strong>the</strong> fundi through pupils which have been dilated with eye drops<br />
Secondary c<strong>are</strong> Services provided by medical specialists who generally do not have fi rst contact<br />
with patients<br />
Severe hypoglycaemia Hypoglycaemia requir<strong>in</strong>g help from ano<strong>the</strong>r person<br />
Shoulder dystocia Any documented evidence of diffi culty with deliver<strong>in</strong>g <strong>the</strong> shoulders after delivery<br />
of <strong>the</strong> baby’s head<br />
S<strong>in</strong>gleton One fetus or baby<br />
Slid<strong>in</strong>g scale Intravenous <strong>in</strong>sul<strong>in</strong> and dextrose <strong>in</strong>fusions with a set of <strong>in</strong>structions for adjust<strong>in</strong>g<br />
<strong>the</strong> dose of <strong>in</strong>sul<strong>in</strong> on <strong>the</strong> basis of blood glucose test results<br />
ix
Glossary and abbreviations<br />
Stillbirth Legal defi nition: a child that has issued forth from its mo<strong>the</strong>r after <strong>the</strong> 24th <strong>we</strong>ek<br />
of <strong>pregnancy</strong> and which did not at any time after be<strong>in</strong>g completely expelled from<br />
its mo<strong>the</strong>r brea<strong>the</strong> or show any o<strong>the</strong>r signs of life (Section 41 of <strong>the</strong> Births and<br />
Deaths Registration Act 1953 as amended by <strong>the</strong> Stillbirth Defi nition Act 1992)<br />
Stillbirth rate The number of stillbirths per 1000 total births (live births and stillbirths)<br />
Term<strong>in</strong>ation of See Legal abortion<br />
<strong>pregnancy</strong><br />
Thrombosis The formation or presence of a clot of coagulated blood <strong>in</strong> a blood vessel<br />
Thyrox<strong>in</strong>e An iod<strong>in</strong>e-conta<strong>in</strong><strong>in</strong>g hormone produced by <strong>the</strong> thyroid gland<br />
Transitional c<strong>are</strong> unit A unit provid<strong>in</strong>g c<strong>are</strong> of term or near-term babies not needed high-dependency or<br />
<strong>in</strong>tensive c<strong>are</strong>, which can be safely delivered without babies be<strong>in</strong>g separated from<br />
<strong>the</strong>ir mo<strong>the</strong>rs<br />
Trimester One of <strong>the</strong> 3-month periods <strong>in</strong>to which <strong>pregnancy</strong> is divided. The fi rst trimester is<br />
0-13 <strong>we</strong>eks of gestation, <strong>the</strong> second trimester is 14-26 <strong>we</strong>eks of gestation, and <strong>the</strong><br />
third trimester is 27 <strong>we</strong>eks of gestation until birth.<br />
Type 1 diabetes There is an absolute defi ciency of <strong>in</strong>sul<strong>in</strong> production, due to autoimmune destruction<br />
of <strong>the</strong> <strong>in</strong>sul<strong>in</strong>-produc<strong>in</strong>g beta cells <strong>in</strong> <strong>the</strong> islets of Langerhans <strong>in</strong> <strong>the</strong> pancreas.<br />
It accounts for 5 – 15% of all people with diabetes.<br />
Type 2 diabetes There is a relative defi ciency of <strong>in</strong>sul<strong>in</strong> production, and/or <strong>the</strong> <strong>in</strong>sul<strong>in</strong> produced<br />
is not effective (<strong>in</strong>sul<strong>in</strong> resistance). It accounts for 85% - 95% of all people<br />
with diabetes.<br />
UK United K<strong>in</strong>gdom<br />
USS Ultrasound scan<br />
x
Foreword<br />
This third and fi nal report of <strong>the</strong> CEMACH national diabetes programme comes at an important time <strong>in</strong> <strong>the</strong><br />
national drive to improve services for women with diabetes <strong>in</strong> <strong>pregnancy</strong>. The National Service Framework<br />
(NSF) for <strong>Diabetes</strong> requires <strong>the</strong> NHS to develop, implement and monitor policies that seek to empo<strong>we</strong>r and<br />
support women with diabetes to optimise <strong>the</strong> outcomes of <strong>the</strong>ir <strong>pregnancy</strong>. The CEMACH report shows<br />
that, whilst progress has been made <strong>in</strong> improv<strong>in</strong>g services for women with diabetes and <strong>the</strong>ir babies, <strong>the</strong>re<br />
is much still to be done to meet <strong>the</strong> standards recommended by <strong>the</strong> NSF. Too many women cont<strong>in</strong>ue to<br />
be poorly prep<strong>are</strong>d for <strong>pregnancy</strong> <strong>in</strong> <strong>the</strong> critical <strong>are</strong>as of glycaemic control and folic acid supplementation.<br />
The report underl<strong>in</strong>es <strong>the</strong> need for an <strong>in</strong>creased focus on diabetes preconception c<strong>are</strong> services and <strong>the</strong><br />
development of strategies to educate women with diabetes of childbear<strong>in</strong>g age. The grow<strong>in</strong>g proportion<br />
of women with type 2 diabetes dur<strong>in</strong>g <strong>pregnancy</strong>, many of whom <strong>are</strong> from m<strong>in</strong>ority ethnic groups, presents<br />
an additional challenge for health services <strong>in</strong> develop<strong>in</strong>g responsive and accessible services.<br />
This CEMACH report has identifi ed several <strong>are</strong>as of good cl<strong>in</strong>ical practice dur<strong>in</strong>g <strong>pregnancy</strong> <strong>in</strong> women<br />
with pre-exist<strong>in</strong>g diabetes. Ho<strong>we</strong>ver, <strong>the</strong>re cont<strong>in</strong>ue to be <strong>are</strong>as where <strong>the</strong>re is room for improvement,<br />
<strong>in</strong>clud<strong>in</strong>g antenatal fetal surveillance, glycaemic control dur<strong>in</strong>g labour and delivery and postnatal diabetes<br />
c<strong>are</strong>. The National Institute for Health and Cl<strong>in</strong>ical Excellence (NICE) is currently <strong>in</strong> <strong>the</strong> fi nal stages of<br />
development of its new guidel<strong>in</strong>e for <strong>the</strong> management of diabetes <strong>in</strong> <strong>pregnancy</strong>. This guidel<strong>in</strong>e, when<br />
taken toge<strong>the</strong>r with <strong>the</strong> CEMACH report, will provide local health services with an unprecedented<br />
<strong>we</strong>alth of material on which to base <strong>the</strong>ir development of improved services for women with diabetes<br />
<strong>in</strong> <strong>pregnancy</strong>.<br />
Sir Liam Donaldson<br />
Chief Medical Officer<br />
Department of Health, England<br />
xi
Preface<br />
The Confi dential Enquiry <strong>in</strong>to Maternal and Child Health (CEMACH) is a unique study <strong>in</strong>to diabetes and<br />
<strong>pregnancy</strong> which gives us a much needed <strong>in</strong>sight <strong>in</strong>to <strong>the</strong> issues surround<strong>in</strong>g this important time of a<br />
woman’s life. Previous modules of CEMACH’s diabetes programme have highlighted <strong>the</strong> <strong>in</strong>creased risk of<br />
stillbirth, per<strong>in</strong>atal mortality and congenital anomaly for babies of women with diabetes. They also sho<strong>we</strong>d<br />
that women <strong>we</strong>re often poorly prep<strong>are</strong>d for <strong>pregnancy</strong> and that <strong>the</strong> c<strong>are</strong> <strong>the</strong>y received with<strong>in</strong> <strong>the</strong> NHS was<br />
not always appropriate.<br />
Now, <strong>the</strong> fi nal enquiry module, which <strong>in</strong>cludes an audit of standards of c<strong>are</strong>, has revealed a worry<strong>in</strong>g lack<br />
of emphasis on c<strong>are</strong> prior to <strong>pregnancy</strong>. The fi nal report draws toge<strong>the</strong>r a <strong>we</strong>alth of <strong>in</strong>formation and shows<br />
us <strong>the</strong> way forward by giv<strong>in</strong>g clear recommendations that will help improve <strong>the</strong> chances of women with<br />
diabetes to have a successful <strong>pregnancy</strong>.<br />
It is crucial that women with diabetes <strong>are</strong> made fully aw<strong>are</strong> of <strong>the</strong> risks <strong>the</strong>y face before <strong>the</strong>y become<br />
pregnant. Those look<strong>in</strong>g after <strong>the</strong>m <strong>the</strong>n need to ensure that all <strong>the</strong> right steps <strong>are</strong> be<strong>in</strong>g taken to<br />
allow women to effectively reduce those risks. The fact that currently many women with diabetes enter<br />
<strong>pregnancy</strong> with poor glycaemic control is of great concern. Better c<strong>are</strong> provision prior to <strong>pregnancy</strong> should<br />
help address <strong>the</strong> issue. The report also shows that social deprivation <strong>in</strong> women with diabetes is associated<br />
with poor <strong>pregnancy</strong> outcome. We now need to make sure that services <strong>are</strong> better targeted to reach <strong>the</strong><br />
most vulnerable members of our communities.<br />
At a time when <strong>the</strong> prevalence of both type 1 and type 2 diabetes <strong>in</strong> <strong>the</strong> UK is <strong>in</strong>creas<strong>in</strong>g rapidly,<br />
<strong>Diabetes</strong> UK believes that <strong>the</strong> recommendations made <strong>in</strong> <strong>the</strong> Confi dential Enquiry <strong>in</strong>to Maternal and<br />
Child Health’s fi nal diabetes <strong>in</strong> <strong>pregnancy</strong> report, need to be taken forward by health service professionals<br />
and commissioners alike.<br />
Positive changes <strong>are</strong> needed to make sure that <strong>pregnancy</strong> and childbirth rema<strong>in</strong> a time of hope and<br />
joy for women with diabetes.<br />
Douglas Smallwood<br />
Chief Executive<br />
<strong>Diabetes</strong> UK<br />
xii
1. Introduction<br />
This is <strong>the</strong> fi nal report of <strong>the</strong> Confi dential Enquiry <strong>in</strong>to Maternal and Child Health (CEMACH) <strong>Diabetes</strong><br />
Programme, which commenced <strong>in</strong> 2002. The programme has focused on <strong>pregnancy</strong> <strong>in</strong> women with<br />
type 1 and type 2 diabetes (with gestational diabetes excluded) and has <strong>in</strong>cluded 3 modules:<br />
1. A survey of diabetes maternity services for women with type 1 and type 2 diabetes <strong>in</strong> England,<br />
Wales and Nor<strong>the</strong>rn Ireland. 1<br />
2. A descriptive study of 3808 pregnancies to women with type 1 and type 2 diabetes <strong>in</strong> England,<br />
Wales and Nor<strong>the</strong>rn Ireland who <strong>we</strong>re identifi ed at any time bet<strong>we</strong>en book<strong>in</strong>g and delivery from<br />
1 March 2002 to 28 February 2003, with follow up to <strong>pregnancy</strong> outcome at 28 days after delivery. 2<br />
3. A national confi dential enquiry review<strong>in</strong>g demographic, social and lifestyle factors, and cl<strong>in</strong>ical c<strong>are</strong><br />
<strong>in</strong> 442 pregnancies to women with type 1 and type 2 diabetes, and <strong>the</strong>ir association with <strong>pregnancy</strong><br />
outcomes. The results of this last module <strong>are</strong> <strong>in</strong>cluded with<strong>in</strong> this report.<br />
1.1 Context of <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme<br />
The topic of diabetes and <strong>pregnancy</strong> was chosen by CEMACH for a number of reasons:<br />
• <strong>Diabetes</strong> is a common medical disorder complicat<strong>in</strong>g <strong>pregnancy</strong>, affect<strong>in</strong>g 1 <strong>in</strong> 250 women<br />
<strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland.<br />
• In <strong>the</strong> mid-1990s, women with diabetes cont<strong>in</strong>ued to have an <strong>in</strong>creased risk of per<strong>in</strong>atal mortality,<br />
stillbirth and poor <strong>pregnancy</strong> outcomes comp<strong>are</strong>d to <strong>the</strong> general maternity population 3-5 , despite<br />
<strong>the</strong> St. V<strong>in</strong>cent’s Declaration <strong>in</strong> 1989 6 , which set a 5 year target for women with diabetes to achieve<br />
similar <strong>pregnancy</strong> outcomes to women without diabetes.<br />
• In 2001, <strong>the</strong> <strong>Diabetes</strong> National Service Framework (NSF) 7 , set out national standards for <strong>the</strong><br />
management of diabetes and <strong>pregnancy</strong>. The CEMACH <strong>Diabetes</strong> Programme offered <strong>the</strong><br />
opportunity to provide a national overview of maternity service provision and cl<strong>in</strong>ical c<strong>are</strong><br />
for women with diabetes, which could be used to evaluate progress <strong>in</strong> implementation of <strong>the</strong> NSF.<br />
1.2 Aims of <strong>the</strong> national enquiry<br />
The aims of <strong>the</strong> enquiry module <strong>we</strong>re:<br />
• To <strong>in</strong>vestigate standards of c<strong>are</strong> provided to women with type 1 and type 2 diabetes <strong>in</strong> England,<br />
Wales and Nor<strong>the</strong>rn Ireland and identify any underly<strong>in</strong>g issues.<br />
• To <strong>in</strong>vestigate any associations bet<strong>we</strong>en poor <strong>pregnancy</strong> outcomes and demographic, social<br />
and lifestyle, and cl<strong>in</strong>ical c<strong>are</strong> factors.<br />
• To <strong>in</strong>vestigate any associations bet<strong>we</strong>en demographic and cl<strong>in</strong>ical characteristics, social<br />
and lifestyle factors, and cl<strong>in</strong>ical c<strong>are</strong> with type of diabetes.<br />
1.3 A need for change<br />
The prevalence of diabetes <strong>in</strong> <strong>the</strong> general population is <strong>in</strong>creas<strong>in</strong>g rapidly, due partly to an <strong>in</strong>creas<strong>in</strong>g<br />
contribution from particular ethnic m<strong>in</strong>ority groups, and <strong>in</strong>creas<strong>in</strong>g obesity <strong>in</strong> <strong>the</strong> general population.<br />
Type 2 diabetes is be<strong>in</strong>g diagnosed more frequently <strong>in</strong> younger age groups <strong>in</strong>clud<strong>in</strong>g children. 8 This is<br />
likely to result <strong>in</strong> a cont<strong>in</strong>u<strong>in</strong>g <strong>in</strong>crease <strong>in</strong> <strong>the</strong> numbers of women with diabetes of childbear<strong>in</strong>g age <strong>in</strong><br />
1
Introduction<br />
England, Wales and Nor<strong>the</strong>rn Ireland, which has signifi cant implications for both primary and secondary<br />
c<strong>are</strong> health services.<br />
The National Institute for Health and Cl<strong>in</strong>ical Excellence (NICE) is due to publish a national guidel<strong>in</strong>e<br />
on diabetes <strong>in</strong> <strong>pregnancy</strong> <strong>in</strong> November 2007, and this is anticipated to provide health professionals<br />
with guidance on <strong>best</strong> practice supported by current evidence.<br />
CEMACH’s fi nd<strong>in</strong>gs will contribute to <strong>the</strong> evidence-base for this guidel<strong>in</strong>e, and it is hoped that <strong>the</strong> fi nd<strong>in</strong>gs<br />
and recommendations of this report will also help <strong>the</strong> NHS to identify any gaps <strong>in</strong> current services and work<br />
towards improv<strong>in</strong>g c<strong>are</strong> and ultimately outcomes for all women with type 1 and type 2 diabetes.<br />
References<br />
1. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health: Maternity services <strong>in</strong> 2002 for women with<br />
type 1 and type 2 diabetes, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2004.<br />
2. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health: Pregnancy <strong>in</strong> women with type 1 and type 2<br />
diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
3. Casson IF, Clarke CA, Howard CV, McKendrick O, Pennycook S, Pharoah PO et al.<br />
Outcomes of <strong>pregnancy</strong> <strong>in</strong> <strong>in</strong>sul<strong>in</strong> dependent women with diabetes: results of a fi ve year<br />
population cohort study. BMJ 1997;315:275-82.<br />
4. Hawthorne G, Robson S, Ryall EA, Sen D, Roberts SH, Ward Platt MP. Prospective population<br />
based survey of outcome of <strong>pregnancy</strong> <strong>in</strong> women with diabetes: results of <strong>the</strong> Nor<strong>the</strong>rn Diabetic<br />
Pregnancy Audit, 1994. BMJ 1997; 315:279-81.<br />
5. Hadden DR, Alexander A, McCance DR, Traub AI. Obstetric and diabetic c<strong>are</strong> for <strong>pregnancy</strong><br />
<strong>in</strong> diabetic women: 10 years outcome analysis, 1985-1995. Nor<strong>the</strong>rn Ireland <strong>Diabetes</strong> Group,<br />
Ulster Obstetrical Society. Diabetic Med: 2001; 18:546-53.<br />
6. Workshop Report. <strong>Diabetes</strong> C<strong>are</strong> and Research <strong>in</strong> Europe: The Sa<strong>in</strong>t V<strong>in</strong>cent Declaration.<br />
Diabetic Med: 1990; 7:360.<br />
7. National Service Framework for <strong>Diabetes</strong> (England) Standards. Department of Health.<br />
The Stationery Offi ce: London; 2001.<br />
8. Ehtisham S. The emergence of type 2 diabetes <strong>in</strong> childhood. Annals of Cl<strong>in</strong>ical Biochemistry<br />
41(Pt1): Jan 2004; 10-6.<br />
2
2. Key fi nd<strong>in</strong>gs of <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme<br />
The three modules of <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme (<strong>the</strong> CEMACH survey of diabetes maternity<br />
services, <strong>the</strong> descriptive study of 3808 pregnancies to women with type 1 and type 2 diabetes, and <strong>the</strong><br />
national enquiry <strong>in</strong>to 521 diabetic pregnancies), have identifi ed a number of key fi nd<strong>in</strong>gs. These fi nd<strong>in</strong>gs<br />
<strong>are</strong> summarised <strong>in</strong> this chapter. Additional details can be found <strong>in</strong> <strong>the</strong> two previous reports of <strong>the</strong> <strong>Diabetes</strong><br />
Programme and <strong>in</strong> <strong>the</strong> relevant chapters of this report.<br />
2.1 Social and demographic characteristics<br />
Women with type 1 diabetes accounted for 73% (2767/3808) of women <strong>in</strong> <strong>the</strong> descriptive study<br />
and women with type 2 diabetes accounted for 27% (1041/3808) of women <strong>in</strong> <strong>the</strong> descriptive study. 1<br />
Women with type 2 diabetes <strong>we</strong>re more likely to be older, multiparous, live <strong>in</strong> a deprived <strong>are</strong>a and<br />
come from a Black, Asian or O<strong>the</strong>r Ethnic m<strong>in</strong>ority group, than women with type 1 diabetes. 1<br />
In <strong>the</strong> enquiry, maternal social deprivation (based on postcode of residence) was associated with<br />
poor <strong>pregnancy</strong> outcome.<br />
Smok<strong>in</strong>g before <strong>pregnancy</strong> <strong>in</strong> women with diabetes was associated with an <strong>in</strong>creased risk of poor<br />
<strong>pregnancy</strong> outcome. Fur<strong>the</strong>r work is required to elucidate <strong>the</strong> <strong>in</strong>terrelationship and relative contribution<br />
of factors such as smok<strong>in</strong>g, deprivation and ethnicity to <strong>pregnancy</strong> outcome <strong>in</strong> women with diabetes.<br />
2.2 Cl<strong>in</strong>ical characteristics<br />
In <strong>the</strong> descriptive study, <strong>the</strong>re was a 36% preterm delivery rate and a 67% caes<strong>are</strong>an section rate for<br />
women with diabetes. 1 This comp<strong>are</strong>s to a 7% preterm delivery rate and a 22% caes<strong>are</strong>an section rate<br />
<strong>in</strong> <strong>the</strong> general maternity population. 2<br />
In <strong>the</strong> descriptive study, 21% of s<strong>in</strong>gleton babies of women with diabetes had a birth <strong>we</strong>ight of 4000g or more<br />
comp<strong>are</strong>d to 11% of s<strong>in</strong>gleton babies <strong>in</strong> <strong>the</strong> general maternity population <strong>in</strong> England, 2002-03. 1 8% of babies<br />
<strong>in</strong> <strong>the</strong> descriptive study had shoulder dystocia, comp<strong>are</strong>d with 3% <strong>in</strong> a regional general maternity population. 3<br />
There was a ten-fold <strong>in</strong>creased <strong>in</strong>cidence of Erb’s palsy <strong>in</strong> babies of women with diabetes comp<strong>are</strong>d<br />
to babies <strong>in</strong> <strong>the</strong> general maternity population <strong>in</strong> <strong>the</strong> UK. 1, 4<br />
Nearly half of women <strong>in</strong> <strong>the</strong> enquiry had recurrent hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong> and more than a tenth<br />
had at least one severe hypoglycaemic episode requir<strong>in</strong>g external help. There was no evidence from casecontrol<br />
analysis that hypoglycaemia was associated with a poor <strong>pregnancy</strong> outcome for <strong>the</strong> baby.<br />
2.3 Pregnancy outcomes<br />
In <strong>the</strong> descriptive study, women with diabetes had signifi cantly <strong>in</strong>creased risks of adverse <strong>pregnancy</strong><br />
outcome comp<strong>are</strong>d to <strong>the</strong> general maternity population: a fi vefold <strong>in</strong>creased risk of stillbirth, a threefold<br />
<strong>in</strong>creased risk of per<strong>in</strong>atal mortality and a twofold <strong>in</strong>creased risk of fetal congenital anomaly. 1<br />
A number of demographic and cl<strong>in</strong>ical characteristics, social and lifestyle factors, and cl<strong>in</strong>ical c<strong>are</strong> factors<br />
<strong>we</strong>re associated with poor <strong>pregnancy</strong> outcome, and <strong>are</strong> discussed <strong>in</strong> detail <strong>in</strong> o<strong>the</strong>r chapters of this report.<br />
3
Key fi nd<strong>in</strong>gs of <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme<br />
2.4 Preconception c<strong>are</strong><br />
In <strong>the</strong> CEMACH survey of maternity services, less than a fi fth of maternity units <strong>in</strong> England, Wales and<br />
Nor<strong>the</strong>rn Ireland provided structured multidiscipl<strong>in</strong>ary preconception c<strong>are</strong> for women with diabetes. 5<br />
Women with diabetes <strong>we</strong>re poorly prep<strong>are</strong>d for <strong>pregnancy</strong>:<br />
• Less than half <strong>we</strong>re recorded to take folic acid supplements prior to <strong>pregnancy</strong><br />
• Less than half <strong>we</strong>re recorded to have had preconception counsell<strong>in</strong>g regard<strong>in</strong>g glycaemic control,<br />
diet, contraception, diabetes complications and alcohol <strong>in</strong>take<br />
• A third <strong>we</strong>re recorded to have a test of glycaemic control <strong>in</strong> <strong>the</strong> 6 months before <strong>pregnancy</strong> 1<br />
• Two-thirds had evidence of suboptimal glycaemic control before conception and <strong>in</strong> <strong>the</strong> fi rst<br />
trimester of <strong>pregnancy</strong>.<br />
Suboptimal preconception c<strong>are</strong>, glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong> and approach of <strong>the</strong><br />
woman to manag<strong>in</strong>g her diabetes <strong>we</strong>re all associated with poor <strong>pregnancy</strong> outcome.<br />
One of <strong>the</strong> ma<strong>in</strong> underly<strong>in</strong>g factors to suboptimal preconception c<strong>are</strong> was failure of provision of appropriate<br />
c<strong>are</strong> by health professionals: preconception counsell<strong>in</strong>g, contraceptive advice, provision of high dose folic<br />
acid, and appropriate screen<strong>in</strong>g and management of diabetes complications.<br />
The ma<strong>in</strong> factors underly<strong>in</strong>g suboptimal glycaemic control and a suboptimal approach to manag<strong>in</strong>g<br />
diabetes <strong>we</strong>re social and lifestyle issues: non-attendance of women at planned appo<strong>in</strong>tments, nonadherence<br />
to medical advice about diabetes management, unplanned <strong>pregnancy</strong> and social factors<br />
<strong>in</strong>clud<strong>in</strong>g language diffi culties, diffi cult domestic circumstances and erratic or busy lifestyles.<br />
Only a m<strong>in</strong>ority of women <strong>in</strong> <strong>the</strong> enquiry appe<strong>are</strong>d to be us<strong>in</strong>g any form of contraception <strong>in</strong> <strong>the</strong> 12 months<br />
before <strong>pregnancy</strong>, based on documentation by adult diabetes services and primary c<strong>are</strong>. This suggests<br />
that women <strong>are</strong> not aw<strong>are</strong> of <strong>the</strong> importance of cont<strong>in</strong>u<strong>in</strong>g effective contraception until <strong>the</strong>ir glycaemic<br />
control is as near-normal as possible.<br />
In <strong>the</strong> enquiry, a m<strong>in</strong>ority of women <strong>we</strong>re documented to be on high dose (5mg) folic acid<br />
before <strong>pregnancy</strong>.<br />
There was poor documentation of preconception c<strong>are</strong> and advice given.<br />
2.5 Cl<strong>in</strong>ical c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong><br />
Suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong> was associated with poor <strong>pregnancy</strong> outcome. Underly<strong>in</strong>g<br />
issues identifi ed <strong>in</strong>cluded suboptimal fetal surveillance (both cardiotocograph and ultrasound monitor<strong>in</strong>g)<br />
and poor management of maternal risks identifi ed dur<strong>in</strong>g <strong>the</strong> course of <strong>pregnancy</strong>.<br />
Suboptimal diabetes c<strong>are</strong> (exclud<strong>in</strong>g glycaemic control) dur<strong>in</strong>g <strong>pregnancy</strong> was associated with poor<br />
<strong>pregnancy</strong> outcome.<br />
4
Suboptimal fetal surveillance of babies with antenatal evidence of macrosomia (defi ned for <strong>the</strong> enquiry<br />
as evidence of fetal size greater than <strong>the</strong> 90th centile for gestation) was associated with poor <strong>pregnancy</strong><br />
outcome. The ma<strong>in</strong> underly<strong>in</strong>g issues identifi ed <strong>we</strong>re lack of timely follow up and poor <strong>in</strong>terpretation<br />
of ultrasound scans.<br />
2.6 Differences bet<strong>we</strong>en women with type 1 and type 2 diabetes<br />
In <strong>the</strong> enquiry, women with type 2 diabetes <strong>we</strong>re more likely to be obese than women with type 1 diabetes.<br />
In <strong>the</strong> 12 months prior to <strong>pregnancy</strong>, women with type 2 diabetes <strong>we</strong>re less likely than women with type 1<br />
diabetes to have a ret<strong>in</strong>al assessment, a test for album<strong>in</strong>uria and to be recorded to be us<strong>in</strong>g contraception.<br />
Women with type 1 diabetes <strong>we</strong>re more likely than women with type 2 diabetes to have recurrent<br />
hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong> or episodes of hypoglycaemia requir<strong>in</strong>g external help. Never<strong>the</strong>less,<br />
a fi fth of pregnant women with type 2 diabetes had recurrent hypoglycaemia.<br />
Fe<strong>we</strong>r women with type 2 diabetes than type 1 diabetes had a ret<strong>in</strong>al assessment <strong>in</strong> <strong>the</strong> fi rst trimester<br />
of <strong>pregnancy</strong> (or at book<strong>in</strong>g if later).<br />
2.7 Cl<strong>in</strong>ical governance issues<br />
In <strong>the</strong> CEMACH survey of maternity services 5 , nearly two-thirds of maternity units <strong>in</strong> England, Wales and<br />
Nor<strong>the</strong>rn Ireland self-reported a multidiscipl<strong>in</strong>ary antenatal team that <strong>in</strong>cluded all <strong>the</strong> health professionals<br />
(obstetrician, diabetes physician, midwife, diabetes specialist nurse, dietitian) recommended by <strong>the</strong><br />
<strong>Diabetes</strong> National Service Framework. 6<br />
There was poor documentation of both obstetric and diabetes c<strong>are</strong> for more than half of women<br />
<strong>in</strong> <strong>the</strong> enquiry.<br />
Concerns <strong>we</strong>re raised at panel enquiry about <strong>the</strong> standard of local guidel<strong>in</strong>es for three-quarters<br />
of women <strong>in</strong> <strong>the</strong> enquiry.<br />
2.8 Neonatal c<strong>are</strong> of term babies of women with diabetes<br />
In <strong>the</strong> CEMACH survey carried out <strong>in</strong> 2002-03 5 , nearly a third of units had a policy of rout<strong>in</strong>ely admitt<strong>in</strong>g<br />
babies of mo<strong>the</strong>rs with diabetes to <strong>the</strong> neonatal unit.<br />
In <strong>the</strong> neonatal enquiry (see Chapter 12, Neonatal c<strong>are</strong> of women with diabetes), one third of term babies<br />
<strong>we</strong>re admitted to a neonatal unit for special c<strong>are</strong> and over half of <strong>the</strong>se admissions <strong>we</strong>re avoidable.<br />
Intention to breastfeed was lo<strong>we</strong>r among mo<strong>the</strong>rs with diabetes than <strong>the</strong> breastfeed<strong>in</strong>g rate <strong>in</strong> <strong>the</strong> general<br />
population. 1 There appe<strong>are</strong>d to be several barriers to breastfeed<strong>in</strong>g, <strong>in</strong>clud<strong>in</strong>g maternal choice, <strong>in</strong>fant formula<br />
given despite maternal choice to breastfeed, and some babies not receiv<strong>in</strong>g an early feed soon after birth.<br />
Blood glucose test<strong>in</strong>g of <strong>the</strong> baby was be<strong>in</strong>g carried out too early follow<strong>in</strong>g delivery, and <strong>in</strong>appropriate<br />
methods of test<strong>in</strong>g <strong>we</strong>re often used.<br />
5
Key fi nd<strong>in</strong>gs of <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme<br />
Two thirds of babies <strong>in</strong> <strong>the</strong> neonatal enquiry had suboptimal c<strong>are</strong> on <strong>the</strong> labour ward and this frequently<br />
impacted on subsequent c<strong>are</strong>.<br />
2.9 Postnatal c<strong>are</strong><br />
Half of women <strong>in</strong> <strong>the</strong> enquiry had suboptimal postnatal diabetes c<strong>are</strong>. The ma<strong>in</strong> underly<strong>in</strong>g issues <strong>we</strong>re<br />
poor management of glycaemic control after delivery, lack of contact with <strong>the</strong> diabetes team, <strong>in</strong>adequate<br />
plans of c<strong>are</strong> at discharge from hospital, and no contraceptive advice given to women.<br />
Women who had a poor <strong>pregnancy</strong> outcome <strong>we</strong>re more likely not to receive postnatal contraceptive advice<br />
and <strong>we</strong>re more likely to have had suboptimal postnatal diabetes c<strong>are</strong>.<br />
In <strong>the</strong> enquiry, women with type 2 diabetes <strong>we</strong>re less likely to receive postnatal contraceptive advice.<br />
References<br />
1. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Pregnancy <strong>in</strong> women with type 1 and type 2<br />
diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
2. The National Sent<strong>in</strong>el Caes<strong>are</strong>an Section Audit Report. Royal College of Obstetricians and<br />
Gynaecologists, Cl<strong>in</strong>ical Effectiveness Support Unit. RCOG Press: London; 2001.<br />
3. Nesbitt TS, Gilbert WM, Herrhen B. Shoulder dystocia and associated risk factors with macrosomic<br />
<strong>in</strong>fants born <strong>in</strong> California. Am J Obstet Gynecol; Aug 1998; 179:476-80.<br />
4. Evans-Jones G, Kay SP, We<strong>in</strong>dl<strong>in</strong>g AM, Cranny G, Ward A, Bradshaw A, et al. Congenital brachial<br />
palsy: <strong>in</strong>cidence, causes, and outcomes <strong>in</strong> <strong>the</strong> United K<strong>in</strong>gdom and Republic of Ireland. Arch Dis<br />
Child Fetal Neonatal Ed; 2003; 88:F185-9.<br />
5. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Maternity services <strong>in</strong> 2002 for women with<br />
type 1 and type 2 diabetes, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2004.<br />
6. National Service Framework for <strong>Diabetes</strong> (England) Standards. Department of Health.<br />
The Stationery Offi ce: London; 2001.<br />
6
3. Summary of recommendations<br />
This chapter <strong>in</strong>cludes <strong>the</strong> recommendations that have been made aris<strong>in</strong>g from <strong>the</strong> fi nd<strong>in</strong>gs of this report.<br />
Details of <strong>the</strong> process follo<strong>we</strong>d to derive <strong>the</strong> recommendations can be found <strong>in</strong> Chapter 5.<br />
The recommendations below apply to all women with type 1 and type 2 diabetes.<br />
Social and lifestyle issues<br />
Cl<strong>in</strong>ical<br />
1. Preconception and maternity services related to <strong>pregnancy</strong> should be easily accessible and<br />
responsive to all women with diabetes, and provide appropriate c<strong>are</strong> and <strong>in</strong>formation.<br />
2. There should be mechanisms <strong>in</strong> place to identify vulnerable communities and <strong>in</strong>dividuals,<br />
so that additional services can be provided as appropriate to women of childbear<strong>in</strong>g age<br />
with diabetes, <strong>the</strong>reby ensur<strong>in</strong>g optimal preconception c<strong>are</strong>.<br />
3. Providers of diabetes c<strong>are</strong> should develop educational strategies that will enable all women<br />
of childbear<strong>in</strong>g age with diabetes to prep<strong>are</strong> adequately for <strong>pregnancy</strong>.<br />
Audit and research<br />
4. Research should be carried out to:<br />
• identify <strong>the</strong> barriers to access<strong>in</strong>g preconception c<strong>are</strong><br />
• identify possible strategies to support self-c<strong>are</strong> and <strong>pregnancy</strong> plann<strong>in</strong>g by women with diabetes.<br />
Cl<strong>in</strong>ical issues: preconception<br />
Cl<strong>in</strong>ical<br />
1. Commissioners of services must ensure that all women with diabetes <strong>are</strong> provided with specialist<br />
preconception services, with access to all members of <strong>the</strong> specialist multidiscipl<strong>in</strong>ary team.<br />
As a m<strong>in</strong>imum, <strong>the</strong>se services should <strong>in</strong>clude:<br />
• Clear signpost<strong>in</strong>g to different aspects of c<strong>are</strong><br />
• Diet and lifestyle advice<br />
• Provision of appropriate contraception<br />
• Higher dose folic acid supplementation<br />
• Smok<strong>in</strong>g cessation support<br />
• Assessment and management of diabetes complications<br />
• Sett<strong>in</strong>g of glycaemic control targets and regular discussion of results of self-monitor<strong>in</strong>g,<br />
to enable <strong>the</strong> woman to achieve control that is as near to normal as possible before conception<br />
• Discussion of diabetes <strong>pregnancy</strong> risks and expected management strategies<br />
• Clear documentation of c<strong>are</strong> and counsell<strong>in</strong>g, ideally us<strong>in</strong>g a standard template.<br />
7
Summary of recommendations<br />
Audit and research<br />
2. Preconception services should be audited to ensure that m<strong>in</strong>imum standards <strong>are</strong> be<strong>in</strong>g met.<br />
Cl<strong>in</strong>ical issues: <strong>pregnancy</strong><br />
Cl<strong>in</strong>ical<br />
1. An <strong>in</strong>dividualised c<strong>are</strong> plan cover<strong>in</strong>g <strong>the</strong> <strong>pregnancy</strong> and postnatal period up to 6 <strong>we</strong>eks should be<br />
clearly documented <strong>in</strong> <strong>the</strong> notes, ideally us<strong>in</strong>g a standard template. The plan may require changes to<br />
be made depend<strong>in</strong>g on <strong>the</strong> cl<strong>in</strong>ical circumstances through <strong>pregnancy</strong>. As a m<strong>in</strong>imum, <strong>the</strong> c<strong>are</strong> plan<br />
should <strong>in</strong>clude:<br />
• Targets for glycaemic control<br />
• Ret<strong>in</strong>al screen<strong>in</strong>g schedule<br />
• Renal screen<strong>in</strong>g schedule<br />
• Fetal surveillance<br />
• Plan for delivery<br />
• <strong>Diabetes</strong> c<strong>are</strong> after delivery.<br />
2. The c<strong>are</strong> plan should be implemented from <strong>the</strong> outset of <strong>pregnancy</strong> by a multidiscipl<strong>in</strong>ary team<br />
present at <strong>the</strong> same time <strong>in</strong> <strong>the</strong> same cl<strong>in</strong>ic. As a m<strong>in</strong>imum, <strong>the</strong> multidiscipl<strong>in</strong>ary team should <strong>in</strong>clude<br />
an obstetrician, diabetes physician, diabetes specialist nurse, diabetes midwife and dietitian.<br />
3. Pregnancies with ultrasound evidence of macrosomia should have a clear management plan put <strong>in</strong><br />
place by a consultant obstetrician. This should <strong>in</strong>clude tim<strong>in</strong>g of follow-up scans, fetal surveillance<br />
and mode and tim<strong>in</strong>g of delivery.<br />
4. A c<strong>are</strong> plan for postnatal management should be clearly documented <strong>in</strong> <strong>the</strong> notes for all women.<br />
As a m<strong>in</strong>imum, this should <strong>in</strong>clude:<br />
• Plan for management of glycaemic control<br />
• Neonatal c<strong>are</strong><br />
• Contraception<br />
• Follow-up c<strong>are</strong> after discharge from hospital.<br />
Audit and research<br />
5. Research should be carried out to <strong>in</strong>vestigate:<br />
• <strong>the</strong> most appropriate management strategy follow<strong>in</strong>g antenatal evidence of macrosomia<br />
<strong>in</strong> babies of women with diabetes<br />
• how <strong>best</strong> to achieve optimal blood glucose control dur<strong>in</strong>g <strong>pregnancy</strong>, labour and delivery.<br />
Cl<strong>in</strong>ical governance<br />
Cl<strong>in</strong>ical<br />
1. Commissioners should recognise <strong>the</strong> complexity of diabetes management immediately before<br />
and dur<strong>in</strong>g <strong>pregnancy</strong>, and ensure that <strong>the</strong> available service provision <strong>in</strong>cludes all members of <strong>the</strong><br />
multidiscipl<strong>in</strong>ary team.<br />
8
2. Patient pathways of c<strong>are</strong> <strong>in</strong>clud<strong>in</strong>g preconception counsell<strong>in</strong>g, <strong>pregnancy</strong> c<strong>are</strong> and post-<strong>pregnancy</strong><br />
management should be <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> cl<strong>in</strong>ical record.<br />
3. Services should review <strong>the</strong>ir local guidel<strong>in</strong>es. The NICE <strong>Diabetes</strong> <strong>in</strong> Pregnancy guidel<strong>in</strong>e,<br />
due to be published <strong>in</strong> November 2007, is anticipated to provide current evidence for <strong>best</strong> practice.<br />
4. In order to raise aw<strong>are</strong>ness, specialist multidiscipl<strong>in</strong>ary teams should provide regular educational<br />
days for all primary and secondary c<strong>are</strong> professionals likely to be <strong>in</strong>volved <strong>in</strong> <strong>the</strong> c<strong>are</strong> of women with<br />
diabetes <strong>in</strong> <strong>the</strong> local population, to cover all aspects of preconception, <strong>pregnancy</strong> and postnatal c<strong>are</strong>.<br />
Audit and research<br />
5. <strong>Diabetes</strong> networks should carry out regular audits of preconception and <strong>pregnancy</strong> services.<br />
Type 1 and type 2 diabetes<br />
Cl<strong>in</strong>ical<br />
1. Dur<strong>in</strong>g <strong>pregnancy</strong>, ret<strong>in</strong>al and renal screen<strong>in</strong>g schedules should be provided for both women<br />
with type 1 and women with type 2 diabetes.<br />
2. Advice about hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong>, <strong>in</strong>clud<strong>in</strong>g prevention and management strategies,<br />
should be provided to both women with type 1 diabetes and women with type 2 diabetes.<br />
Audit and research<br />
3. <strong>Diabetes</strong> networks should audit standards of preconception and <strong>pregnancy</strong> c<strong>are</strong> for both women<br />
with type 1 and women with type 2 diabetes.<br />
Neonatal c<strong>are</strong> of term babies of women with diabetes<br />
1. All units deliver<strong>in</strong>g women with diabetes should have a written policy for <strong>the</strong> management<br />
of <strong>the</strong> baby. The policy should assume that babies will rema<strong>in</strong> with <strong>the</strong>ir mo<strong>the</strong>rs <strong>in</strong> <strong>the</strong> absence<br />
of complications.<br />
2. Mo<strong>the</strong>rs with diabetes should be <strong>in</strong>formed antenatally of <strong>the</strong> benefi cial effects of breastfeed<strong>in</strong>g<br />
on metabolic control for both <strong>the</strong>mselves, and <strong>the</strong>ir babies.<br />
3. Mo<strong>the</strong>rs with diabetes should be offered an opportunity for sk<strong>in</strong>-to-sk<strong>in</strong> contact with <strong>the</strong>ir babies<br />
immediately after delivery. Breastfeed<strong>in</strong>g with<strong>in</strong> one hour of birth should be encouraged.<br />
4. Blood glucose test<strong>in</strong>g performed too early should be avoided <strong>in</strong> <strong>we</strong>ll babies, without signs of<br />
hypoglycaemia. Test<strong>in</strong>g should be performed before a feed, us<strong>in</strong>g a reliable method (ward-based<br />
glucose electrode or laboratory analysis). For all blood glucose tests, <strong>the</strong> time it is performed,<br />
method used, result, and action taken should be clearly documented <strong>in</strong> <strong>the</strong> notes. Fur<strong>the</strong>r research<br />
is needed to defi ne <strong>the</strong> optimal tim<strong>in</strong>g of fi rst blood glucose test <strong>in</strong> babies of diabetic mo<strong>the</strong>rs.<br />
5. Junior paediatric staff should be tra<strong>in</strong>ed <strong>in</strong> <strong>the</strong> management of babies of mo<strong>the</strong>rs with diabetes.<br />
This should <strong>in</strong>clude appreciation of <strong>the</strong> importance of support<strong>in</strong>g early breastfeed<strong>in</strong>g, avoidance of<br />
early blood glucose test<strong>in</strong>g <strong>in</strong> <strong>the</strong> <strong>we</strong>ll baby, and formulation of a written plan agreed with <strong>the</strong> mo<strong>the</strong>r.<br />
6. Midwives should recognise <strong>the</strong> importance of support<strong>in</strong>g early breastfeed<strong>in</strong>g for women with<br />
diabetes, and <strong>the</strong> need to document this aspect of c<strong>are</strong>.<br />
9
4. Methodology<br />
4.1 Introduction<br />
The enquiry module of <strong>the</strong> CEMACH diabetes programme encompassed a case-control study,<br />
a comparison of type 1 and type 2 diabetes, and an audit of c<strong>are</strong>:<br />
• A case-control analysis to exam<strong>in</strong>e any differences <strong>in</strong> demographic factors, social and lifestyle<br />
issues, and cl<strong>in</strong>ical c<strong>are</strong> bet<strong>we</strong>en a) pregnancies result<strong>in</strong>g <strong>in</strong> adverse <strong>pregnancy</strong> outcome (deaths<br />
from 20 <strong>we</strong>eks gestation up to 28 days after delivery or major fetal congenital anomaly at any<br />
gestation) and b) pregnancies result<strong>in</strong>g <strong>in</strong> a normally formed baby surviv<strong>in</strong>g to 28 days of life.<br />
• A comparison of any differences <strong>in</strong> demographic factors, social and lifestyle issues, and cl<strong>in</strong>ical<br />
c<strong>are</strong> bet<strong>we</strong>en women with a) type 1 and b) type 2 diabetes.<br />
• An audit of <strong>the</strong> c<strong>are</strong> received before, dur<strong>in</strong>g and after <strong>pregnancy</strong> by a subset of women with<strong>in</strong><br />
<strong>the</strong> whole study population of <strong>the</strong> CEMACH diabetes programme.<br />
4.2 Selection of pregnancies for enquiry<br />
To enable <strong>the</strong> audit of c<strong>are</strong> and case-control analysis to be conducted, four groups of pregnancies <strong>we</strong>re<br />
selected for enquiry:<br />
1. Anomalies – <strong>pregnancy</strong> to a woman with type 1 or type 2 diabetes result<strong>in</strong>g <strong>in</strong> a s<strong>in</strong>gleton baby<br />
(<strong>in</strong>clud<strong>in</strong>g term<strong>in</strong>ations of <strong>pregnancy</strong> at any gestation, late fetal losses, stillbirths and live births)<br />
with a confi rmed major congenital anomaly, diagnosed up to 28 days of life.<br />
2. Deaths – <strong>pregnancy</strong> to a woman with type 1 or type 2 diabetes result<strong>in</strong>g <strong>in</strong> death of a s<strong>in</strong>gleton baby<br />
from 20 <strong>we</strong>eks of gestation up to 28 days after delivery, exclud<strong>in</strong>g term<strong>in</strong>ations of <strong>pregnancy</strong> and<br />
confi rmed congenital anomalies.<br />
3. Controls – <strong>pregnancy</strong> to a woman with type 1 or type 2 diabetes result<strong>in</strong>g <strong>in</strong> a s<strong>in</strong>gleton birth<br />
deliver<strong>in</strong>g at 20 <strong>we</strong>eks of gestation onwards and surviv<strong>in</strong>g to 28 days of life, exclud<strong>in</strong>g those with<br />
a confi rmed congenital anomaly.<br />
Prelim<strong>in</strong>ary fi nd<strong>in</strong>gs from <strong>the</strong> CEMACH descriptive study of 3808 pregnancies to women with diabetes<br />
<strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland <strong>in</strong> 2002-03 sho<strong>we</strong>d that women with type 2 diabetes appe<strong>are</strong>d<br />
to be more poorly prep<strong>are</strong>d for <strong>pregnancy</strong> and also had an equivalent risk of adverse <strong>pregnancy</strong><br />
outcome to women with type 1 diabetes. 1,2 It was <strong>the</strong>refore decided to enquire on an additional sample<br />
of pregnancies of women with type 2 diabetes to enable a more thorough <strong>in</strong>vestigation of <strong>the</strong> c<strong>are</strong><br />
received by <strong>the</strong>se women.<br />
4. Additional type 2 sample – <strong>pregnancy</strong> to a woman with type 2 diabetes result<strong>in</strong>g <strong>in</strong> a s<strong>in</strong>gleton<br />
birth deliver<strong>in</strong>g at 20 <strong>we</strong>eks of gestation onwards and surviv<strong>in</strong>g to 28 days of life, exclud<strong>in</strong>g those<br />
with a confi rmed congenital anomaly.<br />
All pregnancies meet<strong>in</strong>g <strong>the</strong> defi nition of anomaly or death with<strong>in</strong> <strong>the</strong> CEMACH descriptive study <strong>we</strong>re<br />
selected to form <strong>the</strong> cases for <strong>the</strong> case-control analysis. Controls <strong>we</strong>re randomly sampled from <strong>the</strong><br />
group of pregnancies reported <strong>in</strong> <strong>the</strong> CEMACH descriptive study fi tt<strong>in</strong>g <strong>the</strong> defi nition of a control <strong>in</strong><br />
order to sample one control per case. The additional type 2 pregnancies <strong>we</strong>re randomly sampled from<br />
10
<strong>the</strong> pregnancies meet<strong>in</strong>g this defi nition (see 4. above) after exclusion of <strong>the</strong> type 2 pregnancies which had<br />
already been sampled as controls.<br />
All <strong>the</strong> chapters <strong>in</strong> this report apart from Chapters 5, 10, 11 and 12 refer to <strong>the</strong> cases and controls<br />
described above.<br />
The additional sample of type 2 pregnancies was used only <strong>in</strong> <strong>the</strong> analysis exam<strong>in</strong><strong>in</strong>g differences bet<strong>we</strong>en<br />
women with type 1 and type 2 diabetes, and <strong>the</strong> methodology for this analysis is described separately <strong>in</strong><br />
Chapter 11.<br />
In total, 590 pregnancies <strong>we</strong>re sampled for enquiry. Notes <strong>we</strong>re requested from <strong>the</strong> unit of delivery and<br />
follo<strong>we</strong>d up on three occasions over <strong>the</strong> subsequent three months. Notes <strong>we</strong>re unable to be retrieved for<br />
12% of all notes requested giv<strong>in</strong>g a fi nal total of 521 pregnancies go<strong>in</strong>g for enquiry (table 4.1).<br />
Table 4.1<br />
Summary of notes requested and received<br />
Type of <strong>pregnancy</strong> Total requested Notes not<br />
available<br />
Notes received<br />
Control 245 25 220<br />
Death 110 15 95<br />
Anomaly 138 11 127<br />
Additional Type 2 97 18 79<br />
Total 590 69 521<br />
4.3 Panel process<br />
Medical records of all pregnancies <strong>in</strong> <strong>the</strong> enquiry module <strong>we</strong>re revie<strong>we</strong>d by multidiscipl<strong>in</strong>ary enquiry panels<br />
of senior health c<strong>are</strong> professionals, held at regional level. Panels revie<strong>we</strong>d three or four cases per meet<strong>in</strong>g.<br />
Cases revie<strong>we</strong>d <strong>we</strong>re selected from a national pool exclud<strong>in</strong>g <strong>the</strong> region of <strong>the</strong> assess<strong>in</strong>g panel, to ensure<br />
an <strong>in</strong>dependent assessment of <strong>the</strong> c<strong>are</strong> provided.<br />
In total, 143 panel meet<strong>in</strong>gs <strong>we</strong>re convened bet<strong>we</strong>en April 2004 and December 2005 <strong>in</strong> <strong>the</strong> CEMACH<br />
regions throughout England, Wales and Nor<strong>the</strong>rn Ireland. Panel meet<strong>in</strong>gs did not take place <strong>in</strong> <strong>the</strong> West<br />
Midlands region but any <strong>pregnancy</strong> to a woman deliver<strong>in</strong>g <strong>in</strong> <strong>the</strong> West Midlands that was selected for<br />
enquiry was <strong>in</strong>cluded <strong>in</strong> <strong>the</strong> national pool and revie<strong>we</strong>d by enquiry panels outside of <strong>the</strong> West Midlands.<br />
4.3.1 Panel chairs<br />
Two or three panel chairs <strong>we</strong>re appo<strong>in</strong>ted per region by a central selection committee. The specifi c remit<br />
of <strong>the</strong> panel chairs was to ensure that an equitable process was follo<strong>we</strong>d to reach consensus on each of<br />
<strong>the</strong> specifi c questions asked <strong>in</strong> <strong>the</strong> enquiry pro forma. Panel chairs <strong>we</strong>re <strong>in</strong>vited to attend a tra<strong>in</strong><strong>in</strong>g day<br />
before <strong>the</strong> commencement of <strong>the</strong> panel process. This allo<strong>we</strong>d an opportunity to discuss various challenges<br />
likely to be faced by a panel chair and to develop mechanisms of work<strong>in</strong>g that would ensure a consistent<br />
approach to panel enquiry meet<strong>in</strong>gs across <strong>the</strong> regions.<br />
11
Methodology<br />
4.3.2 Panel composition<br />
Each panel for <strong>the</strong> diabetes enquiry consisted of two of each of <strong>the</strong> follow<strong>in</strong>g discipl<strong>in</strong>es:<br />
• Obstetrician<br />
• Midwife<br />
• <strong>Diabetes</strong> specialist nurse<br />
• <strong>Diabetes</strong> physician.<br />
At least one cl<strong>in</strong>ician from each specialty was required to be present <strong>in</strong> order for <strong>the</strong> panel meet<strong>in</strong>g to take<br />
place. Under exceptional circumstances <strong>the</strong> panel chair could participate as a full assessor if <strong>the</strong>re <strong>we</strong>re no<br />
o<strong>the</strong>r cl<strong>in</strong>icians available from <strong>the</strong>ir specifi c discipl<strong>in</strong>e. If it was not possible for at least one cl<strong>in</strong>ician from<br />
each specialty to be represented <strong>the</strong>n <strong>the</strong> panel meet<strong>in</strong>g was cancelled. Additional panel members whose<br />
<strong>in</strong>put was relevant to particular enquiry cases <strong>we</strong>re <strong>in</strong>vited to attend meet<strong>in</strong>gs as required e.g. general<br />
practitioners, pathologists, neonatologists.<br />
Previous confi dential enquiries had not <strong>in</strong>cluded lay panel assessors. For <strong>the</strong> diabetes enquiry, CEMACH<br />
sought to <strong>in</strong>clude lay assessors on <strong>the</strong> enquiry panels. Criteria for lay panel assessors <strong>we</strong>re agreed with<br />
<strong>Diabetes</strong> UK, and <strong>the</strong> <strong>in</strong>itiative was piloted <strong>in</strong> 2 regions. One lay member attended 5 panel meet<strong>in</strong>gs <strong>in</strong><br />
Yorkshire and Humberside region.<br />
Observers <strong>we</strong>re allo<strong>we</strong>d to attend (with due notice) but <strong>we</strong>re not expected to contribute to <strong>the</strong> discussion<br />
dur<strong>in</strong>g assessment.<br />
In total, 647 health professionals contributed over 5000 hours to panel enquiries over <strong>the</strong> course of <strong>the</strong><br />
enquiry module, with 70 additional observers attend<strong>in</strong>g one or more panels. The median number of cases<br />
revie<strong>we</strong>d by each assessor was 8 (range 4-48).<br />
4.4 Enquiry documentation<br />
Panel members <strong>we</strong>re provided with <strong>the</strong> medical records for each case perta<strong>in</strong><strong>in</strong>g to c<strong>are</strong> <strong>in</strong> <strong>the</strong> antenatal,<br />
delivery and postnatal periods. These <strong>in</strong>cluded diabetes and maternity notes plus any relevant drug<br />
charts, haematology, biochemistry and histology results. Neonatal notes up to day 3 post delivery <strong>we</strong>re<br />
also provided where applicable. Follow<strong>in</strong>g a feasibility exercise at <strong>the</strong> outset of <strong>the</strong> project it was deemed<br />
impractical to collect all medical records perta<strong>in</strong><strong>in</strong>g to diabetes c<strong>are</strong> prior to <strong>the</strong> <strong>pregnancy</strong> of <strong>in</strong>terest.<br />
In order to allow some assessment of c<strong>are</strong> <strong>in</strong> <strong>the</strong> pre-<strong>pregnancy</strong> period a pre-<strong>pregnancy</strong> pro forma was<br />
also completed by a health professional <strong>in</strong>volved <strong>in</strong> <strong>the</strong> preconception c<strong>are</strong> of <strong>the</strong> woman, ei<strong>the</strong>r with<strong>in</strong><br />
<strong>the</strong> adult diabetes service or <strong>in</strong> primary c<strong>are</strong> (see Appendix A). In addition, any professional<br />
correspondence relat<strong>in</strong>g to diabetes management with<strong>in</strong> <strong>the</strong> year preced<strong>in</strong>g <strong>the</strong> last menstrual period<br />
was requested. Women <strong>we</strong>re not contacted directly at any stage of this process, and <strong>in</strong>formation about<br />
social and lifestyle issues and cl<strong>in</strong>ical c<strong>are</strong> was <strong>the</strong>refore based solely on documentation provided by<br />
<strong>the</strong> health professionals <strong>in</strong>volved <strong>in</strong> <strong>the</strong> c<strong>are</strong> of <strong>the</strong> woman and her baby.<br />
In order to ma<strong>in</strong>ta<strong>in</strong> confi dentiality of <strong>the</strong> women, <strong>the</strong>ir families and <strong>the</strong> health professionals <strong>in</strong>volved <strong>in</strong><br />
<strong>the</strong>ir c<strong>are</strong>, all notes provided to panel assessors <strong>we</strong>re anonymised by <strong>the</strong> CEMACH regional managers<br />
12
<strong>in</strong> order to remove any identifi able <strong>in</strong>formation. This <strong>in</strong>cluded patient identifi ers, hospital identifi ers and<br />
staff identifi ers. Where names of staff <strong>we</strong>re anonymised, <strong>the</strong> designation (grade) of <strong>the</strong> staff member<br />
was entered onto <strong>the</strong> documentation, to enable panel assessment of whe<strong>the</strong>r c<strong>are</strong> had been provided<br />
by <strong>the</strong> appropriate grade of staff.<br />
4.5 Assessment of c<strong>are</strong><br />
The scope of this enquiry <strong>in</strong>cluded preconception c<strong>are</strong>, c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong>, labour and delivery, and<br />
postnatal and neonatal c<strong>are</strong> up to 3 days post delivery. A structured enquiry pro forma (see Appendix<br />
B) was developed by <strong>the</strong> CEMACH central offi ce with advice from members of <strong>the</strong> CEMACH <strong>Diabetes</strong><br />
Professional Advisory Group. This pro forma conta<strong>in</strong>ed a mixture of factual questions and assessments<br />
of c<strong>are</strong> from review of <strong>the</strong> medical records, after a round-table discussion and after panel consensus<br />
had been reached. Panel assessors <strong>we</strong>re asked to grade <strong>the</strong>ir op<strong>in</strong>ion of <strong>the</strong> quality of c<strong>are</strong> as ‘optimal’,<br />
‘adequate’ or ‘poor’. ‘Optimal’ <strong>in</strong>dicated that <strong>the</strong>re <strong>we</strong>re no issues with c<strong>are</strong>, while ‘adequate’ <strong>in</strong>dicated that<br />
<strong>the</strong>re <strong>we</strong>re some issues of concern. ‘Adequate’ and ‘poor’ c<strong>are</strong> <strong>we</strong>re aggregated as ‘suboptimal’ c<strong>are</strong> for<br />
<strong>the</strong> purpose of analysis.<br />
If concerns had been identifi ed, panels <strong>we</strong>re asked to describe <strong>the</strong> key issues contribut<strong>in</strong>g to this<br />
assessment and to code <strong>the</strong> issues accord<strong>in</strong>g to <strong>the</strong> follow<strong>in</strong>g categories:<br />
PD<br />
PO<br />
PC<br />
PA<br />
PN<br />
Duration or severity of diabetes.<br />
Issues relat<strong>in</strong>g directly to <strong>the</strong> patient and/or family issues<br />
O<strong>the</strong>r complicat<strong>in</strong>g medical or social and / or lifestyle factors which may h<strong>in</strong>der optimal management e.g.<br />
management-<strong>in</strong>tensive medical conditions such as thrombophilia or cardiac disease, and social factors such<br />
as hous<strong>in</strong>g problems or lack of family support.<br />
Woman actively chose not to follow <strong>the</strong> medical advice given e.g. refusal to undergo <strong>in</strong>duction of labour until<br />
42+ <strong>we</strong>eks of gestation.<br />
Woman’s actions detracted from optimal management e.g. <strong>in</strong>frequent home blood glucose monitor<strong>in</strong>g,<br />
not follow<strong>in</strong>g dietary <strong>in</strong>structions.<br />
Woman did not attend appo<strong>in</strong>tments e.g. failure to attend for cl<strong>in</strong>ic visits or ultrasound scans.<br />
HP<br />
HC<br />
HR<br />
Issues relat<strong>in</strong>g to <strong>the</strong> provision of health services<br />
Cl<strong>in</strong>ical practice e.g. no timely discussion of tim<strong>in</strong>g and mode of delivery.<br />
Communication. This could be a failure of communication bet<strong>we</strong>en professionals car<strong>in</strong>g for <strong>the</strong> woman<br />
e.g. <strong>in</strong>adequate discussion bet<strong>we</strong>en obstetrician and physician, or a failure of communication bet<strong>we</strong>en<br />
professionals and <strong>the</strong> woman e.g. <strong>in</strong>terpret<strong>in</strong>g services <strong>we</strong>re not adequate despite diffi culties with English.<br />
Resources <strong>in</strong>clud<strong>in</strong>g staffi ng e.g. no dietitian <strong>in</strong> <strong>the</strong> antenatal cl<strong>in</strong>ic, lack of midwifery staff on labour ward,<br />
problems with access<strong>in</strong>g timely fetal surveillance such as growth scans.<br />
Panels <strong>we</strong>re asked to code up to four issues that <strong>we</strong>re appropriate to <strong>the</strong> judgment of ‘adequate’ or ‘poor’<br />
c<strong>are</strong>. Dur<strong>in</strong>g analysis, <strong>the</strong>se codes <strong>we</strong>re used as a guide for <strong>the</strong> analysis of <strong>the</strong> <strong>the</strong>mes aris<strong>in</strong>g from <strong>the</strong><br />
free text.<br />
13
Methodology<br />
4.5.1 Panel guidance<br />
Some questions <strong>in</strong> <strong>the</strong> enquiry pro forma <strong>in</strong>cluded guidance for <strong>the</strong> panel assessors. The purpose of this<br />
guidance was to aid consistent defi nitions but was not prescriptive, recognis<strong>in</strong>g that panel assessors may<br />
have had access to <strong>in</strong>formation at panel enquiry which was at variance with <strong>the</strong> guidance provided.<br />
4.6 Case-control analysis<br />
For <strong>the</strong> purposes of <strong>the</strong> case-control analysis, four dist<strong>in</strong>ct sets of analyses <strong>we</strong>re performed. The follow<strong>in</strong>g<br />
four groups <strong>we</strong>re classed as cases and comp<strong>are</strong>d with all controls<br />
1. Anomalies, as per defi nition above (Figure 4.1, B+C)<br />
2. Deaths exclud<strong>in</strong>g anomalies, as per defi nition above (Figure 4.1, A only)<br />
3. All deaths, <strong>in</strong>clud<strong>in</strong>g deaths with congenital anomaly (Figure 4.1, A+B)<br />
4. Poor <strong>pregnancy</strong> outcome - all adverse outcomes formed by groups 1 and 2 toge<strong>the</strong>r<br />
(Figure 4.1, A+B+C)<br />
Figure 4.1<br />
Selection of cases for case-control analysis<br />
Deaths<br />
A<br />
B<br />
C<br />
Major<br />
congenital<br />
anomalies<br />
Associations <strong>in</strong> <strong>the</strong> ma<strong>in</strong> body of <strong>the</strong> report <strong>are</strong> those for group 4 i.e. poor <strong>pregnancy</strong> outcome. Results<br />
from <strong>the</strong> additional analyses <strong>are</strong> <strong>in</strong>cluded <strong>in</strong> Appendices C, D and E. Analyses <strong>are</strong> reported as odds ratios<br />
exam<strong>in</strong><strong>in</strong>g <strong>the</strong> association bet<strong>we</strong>en each factor of <strong>in</strong>terest and adverse <strong>pregnancy</strong> outcome comp<strong>are</strong>d<br />
to <strong>the</strong> control group. Adjusted odds ratios <strong>are</strong> presented where appropriate. Where <strong>the</strong>re <strong>are</strong> notable<br />
differences bet<strong>we</strong>en any of <strong>the</strong> four case defi nitions <strong>in</strong> <strong>the</strong> direction and/or magnitude of a particular<br />
association, <strong>the</strong>se <strong>are</strong> referenced <strong>in</strong> <strong>the</strong> text.<br />
14
When deriv<strong>in</strong>g odds ratios for any particular factor, <strong>in</strong>formation for any particular question which was<br />
recorded as ‘not documented’ or ‘miss<strong>in</strong>g’, <strong>we</strong>re excluded from <strong>the</strong> analysis. Ho<strong>we</strong>ver, when documented<br />
evidence of c<strong>are</strong> was <strong>in</strong>vestigated (<strong>in</strong> Chapters 7 – 9), ‘not documented’ was <strong>in</strong>cluded <strong>in</strong> <strong>the</strong> analysis.<br />
4.7 Type 1 versus type 2 analysis<br />
The methodology for this analysis is described <strong>in</strong> Chapter 11.<br />
4.8 Analysis of panel comments<br />
Panel assessment of <strong>the</strong> quality of c<strong>are</strong> before, dur<strong>in</strong>g and after <strong>pregnancy</strong> was assessed as optimal<br />
versus suboptimal, where suboptimal refl ected a comb<strong>in</strong>ation of ‘adequate’ (some issues with c<strong>are</strong>)<br />
and ‘poor’ responses.<br />
Where a case was considered to have had suboptimal c<strong>are</strong>, panels <strong>we</strong>re asked to summarise <strong>the</strong> key<br />
issues (see enquiry assessment above). These free text fi elds <strong>we</strong>re categorised <strong>in</strong>to one or more <strong>the</strong>me<br />
head<strong>in</strong>gs by an <strong>in</strong>dividual cl<strong>in</strong>ician (obstetrician, diabetes physician or neonatologist as appropriate) to<br />
allow fur<strong>the</strong>r exploration of <strong>the</strong> data. Tables where free text <strong>in</strong>formation has been categorised <strong>are</strong> footnoted<br />
throughout <strong>the</strong> report. Categorisation was based purely on <strong>the</strong> text conta<strong>in</strong>ed <strong>in</strong> <strong>the</strong> pro forma.<br />
4.9 Derivation of recommendations<br />
Recommendations <strong>we</strong>re derived follow<strong>in</strong>g consultation with all members of <strong>the</strong> CEMACH <strong>Diabetes</strong><br />
Professional Advisory Group (PAG) and with regional panel chairs. The draft report was revie<strong>we</strong>d by<br />
<strong>the</strong> <strong>Diabetes</strong> PAG and suggested recommendations sent by <strong>in</strong>dividual PAG members to <strong>the</strong> CEMACH<br />
central offi ce. These recommendations <strong>we</strong>re collated and sent to all PAG members for scor<strong>in</strong>g. Suggested<br />
recommendations <strong>we</strong>re scored for validity (whe<strong>the</strong>r <strong>the</strong> recommendation was based on <strong>the</strong> fi nd<strong>in</strong>gs of <strong>the</strong><br />
report) on a scale of 1-4, where 1 was extremely valid and 4 was not at all valid; and for cl<strong>in</strong>ical importance<br />
(<strong>the</strong> potential of <strong>the</strong> recommendation to impact on cl<strong>in</strong>ical practice or outcomes) on a scale of 1-4, where<br />
1 was of high cl<strong>in</strong>ical importance and 4 was of no cl<strong>in</strong>ical importance.<br />
Any <strong>in</strong>dividual recommendation with a median score of 4 for validity or cl<strong>in</strong>ical importance was excluded.<br />
The scored recommendations <strong>we</strong>re <strong>the</strong>n sent out for consultation to regional panel chairs for a second<br />
round of scor<strong>in</strong>g. Panel chairs <strong>we</strong>re also <strong>in</strong>vited to make any additional recommendations <strong>the</strong>y felt <strong>we</strong>re<br />
both valid and cl<strong>in</strong>ically important.<br />
Follow<strong>in</strong>g a second round of scor<strong>in</strong>g and analysis, a meet<strong>in</strong>g of <strong>the</strong> <strong>Diabetes</strong> PAG and regional<br />
panel chairs was held to review all scored recommendations and reach consensus on <strong>in</strong>clusion of<br />
recommendations with<strong>in</strong> <strong>the</strong> report. These revised recommendations <strong>we</strong>re collated and revie<strong>we</strong>d by <strong>the</strong><br />
Chair of <strong>the</strong> <strong>Diabetes</strong> PAG and CEMACH Central Offi ce, and recommendations <strong>the</strong>n sent out aga<strong>in</strong> to<br />
PAG members and panel chairs for comments. Comments received <strong>we</strong>re revie<strong>we</strong>d, fi nal revisions made,<br />
and <strong>the</strong> recommendations <strong>the</strong>n fi nalised by CEMACH Central Offi ce.<br />
15
Methodology<br />
4.10 Limitations<br />
All data collected dur<strong>in</strong>g this enquiry <strong>we</strong>re derived from review of <strong>the</strong> medical records. F<strong>in</strong>d<strong>in</strong>gs of this<br />
report <strong>are</strong> <strong>the</strong>refore based on documentation <strong>in</strong> <strong>the</strong> medical records of demographic factors, social and<br />
lifestyle issues and cl<strong>in</strong>ical c<strong>are</strong>, and <strong>are</strong> not based on direct question<strong>in</strong>g of cl<strong>in</strong>icians or women.<br />
In many cases it was not possible to complete all questions on <strong>the</strong> pro forma with reference to <strong>the</strong><br />
medical notes provided. The proportion of miss<strong>in</strong>g <strong>in</strong>formation was even more pronounced for <strong>in</strong>formation<br />
perta<strong>in</strong><strong>in</strong>g to <strong>the</strong> pre-<strong>pregnancy</strong> period, where miss<strong>in</strong>g data ranged from less than 5% to more than 50%<br />
for specifi c data items.<br />
Throughout <strong>the</strong> report, numbers <strong>are</strong> reported with reference to <strong>the</strong> total number of records where<br />
<strong>in</strong>formation was recorded i.e. exclud<strong>in</strong>g all miss<strong>in</strong>g data. In general, <strong>the</strong>re was no systematic difference<br />
<strong>in</strong> <strong>the</strong> number of miss<strong>in</strong>g responses dependent on whe<strong>the</strong>r a <strong>pregnancy</strong> was a case or a control.<br />
With regard to panel assessment of women’s behaviour and cl<strong>in</strong>ical c<strong>are</strong>, it should be noted that <strong>the</strong><br />
enquiry sample is not fully representative of <strong>the</strong> whole population of pregnant women with diabetes, as<br />
approximately half of women <strong>in</strong> <strong>the</strong> enquiry had a poor <strong>pregnancy</strong> outcome due to <strong>the</strong> sampl<strong>in</strong>g process.<br />
It is <strong>the</strong>refore possible that <strong>the</strong> issues identifi ed by enquiry panels represent <strong>the</strong> worse end of <strong>the</strong> spectrum<br />
of suboptimal behaviour and c<strong>are</strong>. Ho<strong>we</strong>ver, for many factors exam<strong>in</strong>ed <strong>the</strong>re was no difference bet<strong>we</strong>en<br />
cases and controls.<br />
One of <strong>the</strong> potential limitations to <strong>the</strong> panel enquiry approach is variation of assessments bet<strong>we</strong>en<br />
different regional panels. Panel guidance notes <strong>we</strong>re provided <strong>in</strong> order to m<strong>in</strong>imise variation, and <strong>the</strong><br />
panel chairs and regional managers had an important role to play <strong>in</strong> direct<strong>in</strong>g <strong>the</strong> discussion and ensur<strong>in</strong>g<br />
that all factors <strong>we</strong>re taken <strong>in</strong>to consideration dur<strong>in</strong>g assessments. Panel chairs attended a tra<strong>in</strong><strong>in</strong>g day<br />
(as described above) <strong>in</strong> order to standardise <strong>the</strong> approach to <strong>the</strong> enquiry assessment, and guidance<br />
was provided <strong>in</strong> <strong>the</strong> enquiry pro forma (see appendix B) to aid <strong>in</strong> its completion. Despite this tra<strong>in</strong><strong>in</strong>g and<br />
guidance <strong>the</strong>re rema<strong>in</strong>s a degree of subjectivity <strong>in</strong> <strong>the</strong> panel assessment process which cannot<br />
be completely elim<strong>in</strong>ated.<br />
A source of bias that has been previously experienced <strong>in</strong> some confidential enquiry programmes is that<br />
knowledge of <strong>the</strong> <strong>pregnancy</strong> outcome may affect <strong>the</strong> panel assessment of c<strong>are</strong>. The Project 27/28 study 3<br />
which enquired <strong>in</strong>to standards of c<strong>are</strong> for babies born at 27 and 28 <strong>we</strong>eks gestation, bl<strong>in</strong>ded assessors to<br />
<strong>the</strong> outcome of <strong>the</strong> case up to <strong>the</strong> po<strong>in</strong>t of delivery. In this study, as one of <strong>the</strong> outcomes was congenital<br />
anomaly which could be diagnosed antenatally, it was not possible to bl<strong>in</strong>d <strong>the</strong> panels to <strong>pregnancy</strong> outcome<br />
<strong>in</strong> all cases. For this reason, it was agreed that assessors would not be bl<strong>in</strong>ded to any outcomes for <strong>the</strong><br />
pregnancies be<strong>in</strong>g revie<strong>we</strong>d. This may have led to an element of bias <strong>in</strong> this study particularly with respect to<br />
<strong>the</strong> questions which asked for panel assessment of <strong>the</strong> standard of c<strong>are</strong> received or <strong>the</strong> woman’s approach<br />
to manag<strong>in</strong>g her diabetes. This bias could have led to an overestimate of <strong>the</strong> extent of <strong>the</strong> association of<br />
panel assessment of suboptimal c<strong>are</strong> with adverse <strong>pregnancy</strong> outcome. Results relat<strong>in</strong>g to panel assessment<br />
<strong>are</strong> clearly identified throughout <strong>the</strong> report and should be <strong>in</strong>terpreted with a degree of caution.<br />
16
Associations <strong>are</strong> reported <strong>in</strong> Chapters 6–10 for poor <strong>pregnancy</strong> outcome, which comb<strong>in</strong>es two separate<br />
adverse outcomes, fetal congenital anomaly and death from 20 <strong>we</strong>eks of gestation, comp<strong>are</strong>d to controls.<br />
In some cases, this precludes a more specifi c focus on <strong>the</strong> impact of <strong>the</strong> particular behaviour or c<strong>are</strong> factor<br />
on <strong>in</strong>dividual poor outcomes e.g. fetal anomalies. For this reason, Appendices C, D, and E have been<br />
<strong>in</strong>cluded to provide <strong>in</strong>formation on associations with poor outcome for each additional case defi nition<br />
(fetal congenital anomalies, all deaths, and deaths exclud<strong>in</strong>g anomalies).<br />
It is recognised that some of <strong>the</strong> factors reported to have an association with adverse outcome <strong>are</strong> not<br />
likely to be on <strong>the</strong> causal pathway, for example poor glycaemic control after <strong>the</strong> fi rst trimester of <strong>pregnancy</strong><br />
is unlikely to have been causative for fetal congenital anomaly, and poor diabetes c<strong>are</strong> after delivery is not<br />
causative for poor <strong>pregnancy</strong> outcome. Ho<strong>we</strong>ver, <strong>the</strong>re may be o<strong>the</strong>r explanations for <strong>the</strong>se associations,<br />
and <strong>the</strong>y have <strong>the</strong>refore been reta<strong>in</strong>ed, with discussion <strong>in</strong> <strong>the</strong> text where appropriate.<br />
Results reported with<strong>in</strong> chapter 6 <strong>are</strong> crude odds ratios exam<strong>in</strong><strong>in</strong>g each potential risk factor or assessment<br />
of cl<strong>in</strong>ical c<strong>are</strong> and its association with poor <strong>pregnancy</strong> outcome <strong>in</strong> isolation. In order to allow for potential<br />
confound<strong>in</strong>g factors, all odds ratios <strong>we</strong>re adjusted for <strong>the</strong> effect of maternal age and deprivation on<br />
<strong>pregnancy</strong> outcome and <strong>the</strong>se <strong>are</strong> also displayed. These adjusted odds ratios <strong>are</strong> displayed throughout<br />
chapters 7-9. It is possible, ho<strong>we</strong>ver, that <strong>the</strong>re <strong>are</strong> additional confound<strong>in</strong>g factors or <strong>in</strong>teractions which<br />
have not been allo<strong>we</strong>d for <strong>in</strong> this analysis.<br />
4.11 The diabetes neonatal enquiry<br />
Details on <strong>the</strong> methodology and derivation of recommendations for <strong>the</strong> diabetes neonatal enquiry<br />
can be found <strong>in</strong> Chapter 12.<br />
References<br />
1. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health: Pregnancy <strong>in</strong> women with type 1 and<br />
type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
2. Mac<strong>in</strong>tosh M, Flem<strong>in</strong>g K, Bailey J, Doyle P, Modder J, Acolet D, et al. Per<strong>in</strong>atal mortality and<br />
congenital anomalies <strong>in</strong> babies of women with type 1 or type 2 diabetes <strong>in</strong> England, Wales and<br />
Nor<strong>the</strong>rn Ireland: population based study. BMJ, Jul 22 2006 333 (7560):177.<br />
3. Confi dential Enquiry <strong>in</strong>to Stillbirths and Deaths <strong>in</strong> Infancy. Project 27/28: An Enquiry <strong>in</strong>to quality<br />
of c<strong>are</strong> and its effect on <strong>the</strong> survival of babies born at 27-28 <strong>we</strong>eks. The Stationery Offi ce:<br />
London; 2003.<br />
17
5. A description of women and babies <strong>in</strong> <strong>the</strong> enquiry<br />
5.1 Introduction<br />
This chapter describes <strong>the</strong> 442 women and 442 offspr<strong>in</strong>g <strong>in</strong> <strong>the</strong> enquiry module of <strong>the</strong> CEMACH <strong>Diabetes</strong><br />
Programme, after exclud<strong>in</strong>g <strong>the</strong> additional 79 pregnant women with type 2 diabetes sampled for <strong>the</strong><br />
purpose of carry<strong>in</strong>g out a comparison bet<strong>we</strong>en type 1 and type 2 diabetes (see Chapters 4 and 11).<br />
Multiple births <strong>we</strong>re excluded before sampl<strong>in</strong>g from <strong>the</strong> 3808 pregnancies <strong>in</strong> <strong>the</strong> descriptive study (see<br />
Chapter 4 for details of sampl<strong>in</strong>g methods). All babies who died from 20 <strong>we</strong>eks gestation up to 28 days<br />
after delivery, and all fetal congenital anomalies, <strong>we</strong>re sampled for enquiry, toge<strong>the</strong>r with a random sample<br />
of controls (s<strong>in</strong>gleton babies without a congenital anomaly surviv<strong>in</strong>g to day 28) so that <strong>the</strong>re was one<br />
control for each case sampled. Women with poor <strong>pregnancy</strong> outcomes <strong>the</strong>refore represented a higher<br />
proportion of <strong>the</strong> enquiry sample than of <strong>the</strong> 3808 pregnancies <strong>in</strong> <strong>the</strong> descriptive study (approximately 50%<br />
of pregnancies <strong>in</strong> <strong>the</strong> enquiry module versus less than 10% of all pregnancies <strong>in</strong> <strong>the</strong> descriptive study). 1<br />
5.2 The women<br />
5.2.1 Socio-demographic characteristics<br />
The women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re very similar to <strong>the</strong> whole population sampled from with respect to sociodemographic<br />
characteristics (table 5.1). Slightly more women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re <strong>in</strong> <strong>the</strong> more deprived<br />
qu<strong>in</strong>tiles comp<strong>are</strong>d to women <strong>in</strong> <strong>the</strong> descriptive study.<br />
5.2.2 <strong>Diabetes</strong> complications<br />
T<strong>we</strong>lve percent of 359 women <strong>in</strong> <strong>the</strong> enquiry had nephropathy (panel guidance was that this could be<br />
<strong>in</strong>cipient with microalbum<strong>in</strong>uria or established with persistent dipstick positive prote<strong>in</strong>uria and/or serum<br />
creat<strong>in</strong><strong>in</strong>e greater than 130mmol/l).<br />
Thirty two percent of 316 women had ret<strong>in</strong>opathy (pre-exist<strong>in</strong>g or diagnosed for <strong>the</strong> fi rst time <strong>in</strong> <strong>pregnancy</strong>)<br />
(table 5.2). Fifty one percent of 400 women <strong>in</strong> <strong>the</strong> enquiry had recurrent hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong><br />
and 20% of 311 women had at least one severe hypoglycaemic episode requir<strong>in</strong>g external help.<br />
Information on specifi c diabetes complications was not collected for <strong>the</strong> descriptive study of 3808<br />
pregnancies so direct comparisons cannot be made. Chapter 6 presents <strong>the</strong> proportions of women<br />
with poor <strong>pregnancy</strong> outcome and good <strong>pregnancy</strong> outcome who had diabetes complications.<br />
18
Table 5.1<br />
Characteristics of women (all fi gures <strong>are</strong> % unless o<strong>the</strong>rwise stated)<br />
Socio-demographic characteristics Women <strong>in</strong> <strong>the</strong> enquiry<br />
n (%)<br />
(N=442)<br />
Women <strong>in</strong> <strong>the</strong> CEMACH descriptive study 1<br />
n (%)<br />
(N=3808)<br />
Type of diabetes<br />
Type 1 324 (73) 2767 (73)<br />
Type 2 118 (27) 1041 (27)<br />
Median age at delivery (years) [IQR] 31 [25, 34] 31 [27, 35]<br />
Ethnicity:<br />
White 354 (80) 3059 (80)<br />
Black African 16 (4) 121 (3)<br />
Black Caribbean 9 (2) 84 (2)<br />
Black O<strong>the</strong>r 0 (0) 14 (0.4)<br />
Indian 15 (3) 110 (3)<br />
Pakistani 24 (5) 203 (5)<br />
Bangladeshi 8 (2) 86 (2)<br />
Ch<strong>in</strong>ese 1 (0.2) 7 (0.2)<br />
O<strong>the</strong>r 13 (3) 116 (3)<br />
Not known 2 (0.5) 8 (0.2)<br />
Primigravidas 192 (43) 1507 (40)<br />
Median age at onset of diabetes<br />
19 [10, 26] 20 [11, 28]<br />
(years) [IQR]<br />
Median duration of diabetes (years)<br />
9 [4, 17] 9 [4, 17]<br />
[IQR]<br />
Deprivation qu<strong>in</strong>tile:<br />
1 59 (14) 496 (14)<br />
2 60 (15) 581 (17)<br />
3 72 (18) 638 (18)<br />
4 89 (22) 728 (21)<br />
5 128 (31) 1002 (29)<br />
Miss<strong>in</strong>g or resident <strong>in</strong> Wales or<br />
Nor<strong>the</strong>rn Ireland<br />
34 363<br />
19
A description of women and babies <strong>in</strong> <strong>the</strong> enquiry<br />
Table 5.2<br />
Specifi c diabetes complications <strong>in</strong> women <strong>in</strong> <strong>the</strong> enquiry<br />
Specific diabetes complication<br />
Women <strong>in</strong> <strong>the</strong> enquiry<br />
n/N (%)<br />
Recurrent hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong> 203/400 (51)<br />
Hypoglycaemia requir<strong>in</strong>g external help 63/311 (20)<br />
Pre-exist<strong>in</strong>g ret<strong>in</strong>opathy 73/316 (23)<br />
New ret<strong>in</strong>opathy 29/316 (9)<br />
Nephropathy 42/359 (12)<br />
5.3 The babies<br />
5.3.1 Pregnancy outcomes<br />
The outcomes of all pregnancies <strong>in</strong> <strong>the</strong> enquiry <strong>are</strong> shown <strong>in</strong> table 5.3.<br />
Table 5.3<br />
Outcome of pregnancies <strong>in</strong> <strong>the</strong> enquiry<br />
No congenital anomaly<br />
(N=315)<br />
Congenital anomaly<br />
(N=127)<br />
Total<br />
(N=442)<br />
Alive at 28 days 220 66 286<br />
Loss before 20 <strong>we</strong>eks N/A a 19 19<br />
Late fetal loss 13 26 39<br />
Stillbirth 71 6 77<br />
Early neonatal death 9 4 13<br />
Late neonatal death 2 6 8<br />
a<br />
Not with<strong>in</strong> defi nition of pregnancies sampled for enquiry<br />
Gender was known for 385 of 442 offspr<strong>in</strong>g. There <strong>we</strong>re 192 males, 192 females and one<br />
<strong>in</strong>determ<strong>in</strong>ate sex.<br />
5.3.2 Fetal growth restriction<br />
Thirty seven babies <strong>in</strong> <strong>the</strong> enquiry had documented antenatal evidence of fetal growth restriction or poor<br />
growth velocity (table 5.4). Seventy percent (26/37) of <strong>the</strong>se babies had a poor outcome (death and/or fetal<br />
congenital anomaly) comp<strong>are</strong>d with 50% (222/442) of all babies <strong>in</strong> <strong>the</strong> enquiry. There was no difference <strong>in</strong><br />
<strong>the</strong> distribution of type of diabetes or ethnicity amongst women whose babies had fetal growth restriction<br />
(table 5.4). Ho<strong>we</strong>ver, 31% of <strong>the</strong> women whose babies had antenatal evidence of fetal growth restriction<br />
had nephropathy comp<strong>are</strong>d to 12% of women <strong>in</strong> <strong>the</strong> whole enquiry sample (p=0.002).<br />
20
Table 5.4<br />
Characteristics of women whose babies had antenatal evidence of fetal growth restriction<br />
Maternal characteristics<br />
Women with antenatal evidence of<br />
fetal growth restriction<br />
n (%)<br />
(N=37)<br />
All women <strong>in</strong> <strong>the</strong> enquiry<br />
n (%)<br />
(N=442)<br />
Type of diabetes<br />
Type 1 26 (70) 324 (73)<br />
Type 2 11 (30) 118 (27)<br />
Ethnicity<br />
White 31 (84) 354 (80)<br />
Black 3 (8) 25 (6)<br />
Asian 2 (5) 47 (11)<br />
Ch<strong>in</strong>ese and O<strong>the</strong>r 1 (3) 14 (3)<br />
Median maternal age (years) [IQR] 33 [30, 34] 31 [25, 34]<br />
Nephropathy 10/32 (31) 42/359 (12)<br />
5.3.3 Macrosomia<br />
One hundred and t<strong>we</strong>nty n<strong>in</strong>e babies had documented antenatal evidence of macrosomia (<strong>the</strong> guidance<br />
given to panels was evidence of fetal size greater than <strong>the</strong> 90th centile for gestational age). Forty one<br />
percent (53/129) of <strong>the</strong>se babies had a poor outcome; this was similar to <strong>the</strong> proportion (50%, 222/442) of<br />
all babies <strong>in</strong> <strong>the</strong> enquiry hav<strong>in</strong>g a poor outcome. There was a slightly greater proportion of type 1 diabetes<br />
and White ethnicity <strong>in</strong> women whose babies had antenatal evidence of macrosomia comp<strong>are</strong>d to all women<br />
<strong>in</strong> <strong>the</strong> enquiry sample, but this did not reach significance (p=0.13 and p=0.08 respectively) (table 5.5).<br />
Table 5.5<br />
Characteristics of women whose babies had antenatal evidence of macrosomia<br />
Maternal characteristics<br />
Women with antenatal evidence<br />
of fetal macrosomia<br />
n (%) a<br />
(N=129)<br />
All women <strong>in</strong> <strong>the</strong> enquiry<br />
n (%)<br />
(N=442)<br />
Type of diabetes<br />
Type 1 103 (80) 324 (73)<br />
Type 2 26 (20) 118 (27)<br />
Ethnicity<br />
White 112 (88) 354 (80)<br />
Black 7 (5) 25 (6)<br />
Asian 6 (5) 47 (10)<br />
Ch<strong>in</strong>ese and O<strong>the</strong>r 3 (2) 14 (3.2)<br />
Maternal age (years) [IQR] 31 [26, 34] 31 [25, 34]<br />
Nephropathy 10/102 (10) 42/359 (12)<br />
a<br />
Percentages <strong>are</strong> <strong>the</strong> proportion of women <strong>in</strong> a category out of <strong>the</strong> total number of women with a valid response, i.e. exclud<strong>in</strong>g ‘not<br />
applicable’ and ‘miss<strong>in</strong>g’.<br />
21
A description of women and babies <strong>in</strong> <strong>the</strong> enquiry<br />
5.3.4 Fetal congenital anomalies<br />
A total of 127 offspr<strong>in</strong>g of women <strong>in</strong> <strong>the</strong> enquiry had a confi rmed major congenital anomaly, us<strong>in</strong>g <strong>the</strong><br />
European Surveillance of Congenital Anomalies (EUROCAT) classifi cation system. 2 Over half of <strong>the</strong>se<br />
babies survived beyond <strong>the</strong> neonatal period (table 5.3). Two thirds of <strong>the</strong> anomalies <strong>we</strong>re detected<br />
antenatally. More details about fetal congenital anomalies <strong>in</strong> <strong>the</strong> CEMACH programme can be<br />
found elsewhere. 1,3<br />
5.3.5 Deaths<br />
A total of 137 babies <strong>in</strong> <strong>the</strong> enquiry died from 20 <strong>we</strong>eks gestation up to 28 days after delivery. Forty two<br />
(31%) of <strong>the</strong>se babies had a confi rmed major congenital anomaly (table 5.3).<br />
The cause of death for stillbirths and neonatal deaths (babies who died from 24 <strong>we</strong>eks of gestation up<br />
to 28 days after delivery) was categorised accord<strong>in</strong>g to <strong>the</strong> Extended Wigglesworth classifi cation 4 us<strong>in</strong>g<br />
<strong>in</strong>formation with<strong>in</strong> <strong>the</strong> medical records, <strong>in</strong>clud<strong>in</strong>g postmortem where available. The distribution of causes<br />
of death by major category was comp<strong>are</strong>d to <strong>the</strong> general maternity population (table 5.6). There was a<br />
greater proportion of unexpla<strong>in</strong>ed antepartum stillbirths amongst babies of women with diabetes than <strong>in</strong> <strong>the</strong><br />
general maternity population. There <strong>we</strong>re a greater proportion of deaths due to immaturity <strong>in</strong> <strong>the</strong> general<br />
maternity population, despite <strong>the</strong> fact that <strong>the</strong> preterm delivery rate for women with diabetes was fi ve times<br />
higher than <strong>in</strong> <strong>the</strong> general population. 1 Fur<strong>the</strong>r work needs to be done to <strong>in</strong>vestigate <strong>the</strong> possible reasons<br />
for this difference.<br />
Table 5.6<br />
Cause of death of stillbirths and neonatal deaths (Extended Wigglesworth classifi cation)<br />
Extended Wigglesworth<br />
classification*<br />
Stillbirths and neonatal deaths<br />
<strong>in</strong> enquiry<br />
n (%)<br />
(N=98)<br />
Stillbirths and neonatal<br />
deaths <strong>in</strong> general maternity<br />
population (2002)5<br />
n (%)<br />
(N=5756)<br />
P-value<br />
Congenital defect / malformation<br />
18 (18) 1087 (19) 0.68<br />
(lethal or severe)<br />
Unexpla<strong>in</strong>ed antepartum fetal death 58 (59) 2516 (44) 0.002<br />
Death from <strong>in</strong>trapartum causes 10 (10) 429 (8) 0.30<br />
Immaturity 4 (4) 1027 (18)
was no <strong>in</strong>formation available to panels as to why <strong>the</strong> postmortem exam<strong>in</strong>ation was not carried out despite<br />
be<strong>in</strong>g offered. In one case only external exam<strong>in</strong>ation was performed, and for one case it was documented<br />
<strong>in</strong> <strong>the</strong> medical records that postmortem exam<strong>in</strong>ation was not needed. Overall, 45% (62/137) of babies who<br />
died <strong>we</strong>re documented to have had a postmortem exam<strong>in</strong>ation, which is slightly higher than <strong>the</strong> national<br />
average of 40% <strong>in</strong> 2002-03. 5<br />
Postmortem exam<strong>in</strong>ation fi nd<strong>in</strong>gs <strong>we</strong>re available to <strong>the</strong> panel for 57 out of 62 babies and <strong>are</strong> reported <strong>in</strong><br />
table 5.7. The reported <strong>in</strong>cidence of islet cell hyperplasia and eos<strong>in</strong>ophilic <strong>in</strong>fi ltrates <strong>in</strong> <strong>the</strong> pancreas was<br />
lo<strong>we</strong>r <strong>in</strong> this group of babies than <strong>in</strong> previous reports. 6 It is diffi cult to be certa<strong>in</strong> of <strong>the</strong> reasons for this<br />
difference, but possibilities <strong>in</strong>clude under-report<strong>in</strong>g due to advanced autolysis, a particular problem<br />
<strong>in</strong> <strong>the</strong> pancreas.<br />
Table 5.7<br />
Postmortem exam<strong>in</strong>ation fi nd<strong>in</strong>gs <strong>in</strong> babies who died after 20 <strong>we</strong>eks gestation hav<strong>in</strong>g a postmortem<br />
Specific f<strong>in</strong>d<strong>in</strong>gs reported n (%)<br />
(N=57)* †<br />
Islet cell hyperplasia 6 (11)<br />
Eos<strong>in</strong>ophilic pancreatitis 1 (2)<br />
Cardiomegaly 10 (18)<br />
Vascular thrombosis 0 (0)<br />
No abnormality reported on postmortem 41 (72)<br />
* 5 postmortem exam<strong>in</strong>ation reports <strong>we</strong>re not available.<br />
† There may have been more than one fi nd<strong>in</strong>g reported for any baby undergo<strong>in</strong>g postmortem exam<strong>in</strong>ation.<br />
5.4 Conclusions<br />
Women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re similar to women <strong>in</strong> <strong>the</strong> descriptive study with respect to socio-demographic<br />
characteristics. Due to <strong>the</strong> sampl<strong>in</strong>g methodology for <strong>the</strong> enquiry (see Chapter 4), half of <strong>the</strong> women <strong>in</strong> <strong>the</strong><br />
enquiry had a poor <strong>pregnancy</strong> outcome.<br />
T<strong>we</strong>lve percent of women <strong>in</strong> <strong>the</strong> enquiry had nephropathy and 32% had ret<strong>in</strong>opathy (pre-exist<strong>in</strong>g or<br />
diagnosed for <strong>the</strong> fi rst time <strong>in</strong> <strong>pregnancy</strong>). About half of women <strong>in</strong> <strong>the</strong> enquiry had recurrent hypoglycaemia<br />
dur<strong>in</strong>g <strong>pregnancy</strong> and a fi fth had at least one severe hypoglycaemic episode requir<strong>in</strong>g external help.<br />
Babies with antenatal evidence of fetal growth restriction had a higher proportion of mo<strong>the</strong>rs with<br />
nephropathy comp<strong>are</strong>d to all babies <strong>in</strong> <strong>the</strong> enquiry, and 70% had a poor outcome. Forty one per cent<br />
of babies with antenatal evidence of macrosomia had a poor outcome, which was similar to <strong>the</strong> 50% of<br />
babies <strong>in</strong> <strong>the</strong> whole enquiry sample with a poor outcome.<br />
Sixteen percent of babies who died from 24 <strong>we</strong>eks of gestation up to 28 days after delivery had a cause<br />
of death classifi ed as ‘severe or lethal congenital anomaly’. Women <strong>in</strong> <strong>the</strong> enquiry had a higher proportion<br />
of unexpla<strong>in</strong>ed antepartum fetal death and a lo<strong>we</strong>r proportion of deaths due to immaturity than <strong>the</strong> general<br />
maternity population. Nearly half of all babies who died had a postmortem exam<strong>in</strong>ation.<br />
23
A description of women and babies <strong>in</strong> <strong>the</strong> enquiry<br />
References<br />
1. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Pregnancy <strong>in</strong> women with type 1 and<br />
type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
2. EUROCAT Report 8: Surveillance of Congenital Anomalies <strong>in</strong> Europe 1980-1999. European<br />
Registration of Congenital Anomalies. University of Ulster: Belfast; 2002.<br />
3. Mac<strong>in</strong>tosh MCM, Flem<strong>in</strong>g KM, Bailey JA, Doyle P, Modder J, Acolet D, et al. Per<strong>in</strong>atal mortality<br />
and congenital anomalies <strong>in</strong> babies of women with type 1 or type 2 diabetes <strong>in</strong> England, Wales<br />
and Nor<strong>the</strong>rn Ireland: population based study. BMJ 2006; 333:177.<br />
4. Confi dential Enquiry <strong>in</strong>to Stillbirths and Deaths <strong>in</strong> Infancy. 4th Annual Report 1 January – 31<br />
December 1995. Maternal and Child Health Research Consortium: London; 1997.<br />
5. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Stillbirth, Neonatal and Post-neonatal<br />
Mortality 2000 – 2003, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
6. Jaffe R. In Wigglesworth JS, S<strong>in</strong>ger DB eds. The pancreas. Textbook of Fetal and Per<strong>in</strong>atal<br />
Pathology. Black<strong>we</strong>ll: Massacussetts: 900-932.<br />
24
6. Factors associated with poor <strong>pregnancy</strong> outcome<br />
<strong>in</strong> women with type 1 and type 2 diabetes<br />
6.1 Introduction<br />
Women with type 1 and type 2 diabetes cont<strong>in</strong>ue to have an <strong>in</strong>creased risk of adverse <strong>pregnancy</strong><br />
outcomes, <strong>in</strong>clud<strong>in</strong>g miscarriage, fetal congenital anomaly and per<strong>in</strong>atal death. 1-4 A case-control<br />
approach was utilised with<strong>in</strong> <strong>the</strong> enquiry module to exam<strong>in</strong>e <strong>the</strong> association of demographic and cl<strong>in</strong>ical<br />
characteristics, social and lifestyle factors and cl<strong>in</strong>ical c<strong>are</strong> with poor <strong>pregnancy</strong> outcome.<br />
6.2 Methodology<br />
Poor <strong>pregnancy</strong> outcome was defi ned as a s<strong>in</strong>gleton baby with a major congenital anomaly who delivered<br />
at any gestation and/or a baby who died from 20 <strong>we</strong>eks gestation up to 28 days after delivery.<br />
There <strong>we</strong>re 222 cases that met <strong>the</strong> defi nition of poor <strong>pregnancy</strong> outcome. These comprised:<br />
• Sixty one s<strong>in</strong>gleton babies with a major congenital anomaly who died at any gestation dur<strong>in</strong>g<br />
<strong>pregnancy</strong> and up to 28 days after delivery. This <strong>in</strong>cluded term<strong>in</strong>ations of <strong>pregnancy</strong> for fetal<br />
congenital anomaly.<br />
• N<strong>in</strong>ety fi ve s<strong>in</strong>gleton babies without a major congenital anomaly who died from 20 <strong>we</strong>eks gestation<br />
up to 28 days after delivery.<br />
• Sixty six babies with a major congenital anomaly who survived to 28 days after delivery.<br />
There <strong>we</strong>re 220 controls (s<strong>in</strong>gleton babies without a major congenital anomaly who survived to day<br />
28 after delivery).<br />
Odds ratios and associated 95% confi dence <strong>in</strong>tervals <strong>we</strong>re calculated to exam<strong>in</strong>e each factor identifi ed by<br />
panels and its association with adverse outcomes. Odds ratios <strong>are</strong> also displayed adjust<strong>in</strong>g for maternal<br />
age and deprivation, where appropriate, to allow for <strong>the</strong> potential confound<strong>in</strong>g by <strong>the</strong>se factors.<br />
6.2.1 Additional analyses<br />
In addition to <strong>the</strong> primary analysis (section 6.2), associations of different factors with outcome <strong>we</strong>re also<br />
analysed us<strong>in</strong>g three separate case defi nitions:<br />
• All major fetal congenital anomalies<br />
• All deaths from 20 <strong>we</strong>eks gestation up to 28 days after delivery<br />
• Deaths from 20 <strong>we</strong>eks gestation up to 28 days after delivery, exclud<strong>in</strong>g major fetal<br />
congenital anomalies.<br />
The results of <strong>the</strong>se analyses can be found <strong>in</strong> Appendices C, D and E. In most cases <strong>the</strong> direction of<br />
association was <strong>the</strong> same regardless of <strong>the</strong> case defi nition used. Any notable differences <strong>are</strong> highlighted<br />
throughout <strong>the</strong> text.<br />
6.3 Results<br />
Associations of factors with poor <strong>pregnancy</strong> outcome <strong>are</strong> presented below. Each group of factors is<br />
discussed <strong>in</strong> more detail <strong>in</strong> <strong>the</strong> relevant chapter <strong>in</strong> this report.<br />
25
Factors associated with poor <strong>pregnancy</strong> outcome<br />
<strong>in</strong> women with type 1 and type 2 diabetes<br />
6.3.1 Socio-demographic characteristics<br />
Associations with poor <strong>pregnancy</strong> outcome <strong>we</strong>re <strong>in</strong>vestigated for specifi c social and demographic<br />
characteristics, <strong>in</strong>clud<strong>in</strong>g age, ethnicity, social deprivation, and gravidity (table 6.1).<br />
Table 6.1<br />
Association of demographic characteristics <strong>in</strong> women with type 1 and type 2 diabetes with poor <strong>pregnancy</strong> outcome<br />
Demographic characteristic<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR<br />
[95% CI]<br />
Age - - 1.0 [1.0, 1.0] 1.0 [1.0, 1.0] b<br />
Black, Asian or O<strong>the</strong>r Ethnic<br />
M<strong>in</strong>ority group 47/222 (21) 41/220 (19) 1.2 [0.7, 1.9] 0.9 [0.5, 1.5] a<br />
Primigravidity 100/222 (45) 92/220 (42) 1.1 [0.8, 1.7] 1.3 [0.9, 2.0] a<br />
Maternal social deprivation d - - 1.2 [1.1, 1.4] 1.2 [1.1, 1.4] c<br />
a<br />
adjusted for maternal age and deprivation.<br />
b<br />
adjusted for maternal deprivation.<br />
c<br />
adjusted for maternal age. Odds ratio is for one year <strong>in</strong>crease <strong>in</strong> maternal age.<br />
d<br />
Qu<strong>in</strong>tile of social deprivation derived from postcode of residence. Odds ratio is for unit <strong>in</strong>crease <strong>in</strong> deprivation qu<strong>in</strong>tile.<br />
Maternal deprivation was associated with poor <strong>pregnancy</strong> outcome for women with type 1 and type 2<br />
diabetes. This was similar to <strong>the</strong> general maternity population nationally, with over one third of all stillbirths<br />
and neonatal deaths <strong>in</strong> 2004 be<strong>in</strong>g born to mo<strong>the</strong>rs resident <strong>in</strong> <strong>the</strong> most deprived qu<strong>in</strong>tile. 5<br />
Ho<strong>we</strong>ver, ethnicity was not associated with poor <strong>pregnancy</strong> outcome for women <strong>in</strong> <strong>the</strong> enquiry sample,<br />
which is different to previous fi nd<strong>in</strong>gs for <strong>the</strong> general maternity population. 5,6 CEMACH is committed to<br />
fur<strong>the</strong>r <strong>in</strong>vestigat<strong>in</strong>g <strong>the</strong> contribution of ethnicity and deprivation to specifi c <strong>pregnancy</strong> outcomes for women<br />
with type 1 and type 2 diabetes.<br />
6.3.2 Cl<strong>in</strong>ical characteristics<br />
The cl<strong>in</strong>ical characteristics exam<strong>in</strong>ed <strong>in</strong>cluded characteristics of <strong>the</strong> women such as Body Mass Index<br />
(BMI); known complications of diabetes before <strong>pregnancy</strong>; ret<strong>in</strong>opathy, nephropathy and hypoglycaemia<br />
dur<strong>in</strong>g <strong>pregnancy</strong>; and evidence of fetal growth restriction or macrosomia dur<strong>in</strong>g <strong>pregnancy</strong>. The results<br />
<strong>are</strong> shown <strong>in</strong> table 6.2. Women with pre-exist<strong>in</strong>g diabetes complications <strong>we</strong>re more likely to have a poor<br />
<strong>pregnancy</strong> outcome. Ho<strong>we</strong>ver, nephropathy and recurrent or severe hypoglycaemia <strong>in</strong> <strong>pregnancy</strong> <strong>we</strong>re not<br />
shown to be associated with poor <strong>pregnancy</strong> outcome. Antenatal evidence of fetal growth restriction was<br />
associated with poor <strong>pregnancy</strong> outcome but antenatal evidence of fetal macrosomia was not.<br />
26
Table 6.2<br />
Association of cl<strong>in</strong>ical characteristics of women with type 1 and type 2 diabetes and <strong>the</strong>ir babies, with poor<br />
<strong>pregnancy</strong> outcome<br />
Cl<strong>in</strong>ical characteristics<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
[95% CI]<br />
Body Mass Index (BMI) ≥30 40/136 (29) 33/137 (24) 1.3 [0.8, 2.3] 1.1 [0.6, 1.9]<br />
Pre-exist<strong>in</strong>g diabetes complications 37/182 (20) 16/197 (8) 2.9 [1.5, 5.5] 2.6 [1.3, 4.9]<br />
Ret<strong>in</strong>opathy <strong>in</strong> <strong>pregnancy</strong> 55/149 (37) 50/167 (30) 1.4 [0.9, 2.2] 1.4 [0.9, 2.4]<br />
Diabetic nephropathy <strong>in</strong> <strong>pregnancy</strong> 28/174 (16) 14/185 (8) 2.3 [1.2, 4.7] 2.0 [1.0, 4.2]<br />
Recurrent episodes of hypoglycaemia 98/195 (50) 105/205 (51) 1.0 [0.7, 1.4] 1.1 [0.7, 1.7]<br />
dur<strong>in</strong>g <strong>pregnancy</strong><br />
Severe hypogylacemia dur<strong>in</strong>g <strong>pregnancy</strong><br />
(one or more episode of hypoglycaemia 31/144 (22) 32/167 (19) 1.2 [0.7, 2.0] 1.3 [0.7, 2.3]<br />
requir<strong>in</strong>g external help)<br />
Antenatal evidence of fetal growth<br />
restriction 26/186 (14) 11/218 (5) 3.1 [1.5, 6.4] 2.9 [1.4, 6.3]<br />
Antenatal evidence of macrosomia<br />
(fetal size >90th centile) 53/179 (30) 76/216 (35) 0.8 [0.5, 1.2] 0.8 [0.5, 1.3]<br />
a<br />
adjusted for maternal age and deprivation.<br />
6.3.3 Social and lifestyle factors<br />
In <strong>the</strong> enquiry, a number of social and lifestyle factors <strong>we</strong>re signifi cantly associated with poor <strong>pregnancy</strong><br />
outcome (table 6.3), and <strong>the</strong>se <strong>are</strong> fur<strong>the</strong>r discussed <strong>in</strong> Chapter 7. There appears to be an urgent need<br />
for fur<strong>the</strong>r research <strong>in</strong>to <strong>the</strong> socio-cultural factors affect<strong>in</strong>g women’s behaviour; education programmes for<br />
women and health professionals; and consideration of how <strong>best</strong> to develop diabetes maternity services.<br />
Table 6.3<br />
Association of social and lifestyle factors <strong>in</strong> women with type 1 and type 2 diabetes with poor <strong>pregnancy</strong> outcome<br />
Social and lifestyle factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
[95% CI]<br />
Unplanned <strong>pregnancy</strong> 72/141 (51) 55/144 (38) 1.7 [1.1, 2.7] 1.8 [1.0, 2.9]<br />
No contraceptive use <strong>in</strong> <strong>the</strong> 12 months before<br />
<strong>pregnancy</strong> 71/108 (66) 54/121 (45) 2.4 [1.4, 4.1] 2.3 [1.3, 4.0]<br />
No folic acid commenced prior to <strong>pregnancy</strong> 83/120 (69) 66/131 (50) 2.2 [1.3, 3.8] 2.2 [1.3, 3.9]<br />
Smok<strong>in</strong>g 63/183 (34) 44/182 (24) 1.7 [1.0, 2.6] 1.9 [1.2, 3.2]<br />
Assessment of suboptimal approach<br />
of <strong>the</strong> woman to manag<strong>in</strong>g her diabetes<br />
137/160 (83) 88/154 (57) 4.5 [2.5, 7.9] 4.9 [2.7, 8.8]<br />
before <strong>pregnancy</strong><br />
Assessment of suboptimal approach<br />
of <strong>the</strong> woman to manag<strong>in</strong>g her diabetes<br />
dur<strong>in</strong>g <strong>pregnancy</strong><br />
118/197 (60) 56/207 (27) 4.0 [2.6, 6.3] 3.9 [2.5, 6.1]<br />
a<br />
adjusted for maternal age and deprivation.<br />
27
Factors associated with poor <strong>pregnancy</strong> outcome<br />
<strong>in</strong> women with type 1 and type 2 diabetes<br />
6.3.4 Glycaemic control<br />
A test of glycaemic control before <strong>pregnancy</strong>, local glycaemic control targets, and panel assessments of<br />
glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong>, <strong>we</strong>re exam<strong>in</strong>ed <strong>in</strong> relation to poor <strong>pregnancy</strong> outcome<br />
(table 6.4). A lack of local glycaemic control targets, and suboptimal glycaemic control before and dur<strong>in</strong>g<br />
<strong>pregnancy</strong> <strong>we</strong>re associated with poor <strong>pregnancy</strong> outcome. These issues <strong>are</strong> discussed fur<strong>the</strong>r <strong>in</strong><br />
Chapters 7 and 8.<br />
Table 6.4<br />
Association of factors related to glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong> <strong>in</strong> women with type 1 and type 2<br />
diabetes, with poor <strong>pregnancy</strong> outcome<br />
Factor related to glycaemic control<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
[95% CI]<br />
No test of glycaemic control <strong>in</strong> <strong>the</strong><br />
12 months prior to <strong>pregnancy</strong> 36/139 (26) 24/139 (17) 1.7 [0.9, 3.0] 1.5 [0.8, 2.8]<br />
No local targets set for glycaemic control 44/90 (49) 28/86 (33) 2.0 [1.1, 3.7] 2.0 [1.0, 3.8]<br />
Assessment of suboptimal preconception<br />
glycaemic control 165/187 (88) 115/167 (69) 3.4 [1.9, 6.0] 3.9 [2.2, 7.0]<br />
Assessment of suboptimal 1st trimester<br />
glycaemic control 171/204 (84) 118/192 (61) 3.3 [2.0, 5.3] 3.4 [2.1, 5.7]<br />
Assessment of suboptimal glycaemic<br />
control after 1st trimester 146/205 (71) 76/209 (37) 4.3 [2.8, 6.7] 5.2 [3.3, 8.2]<br />
Assessment of suboptimal glycaemic<br />
control dur<strong>in</strong>g labour and delivery 80/162 (49) 96/202 (48) 0.9 [0.6, 1.4] 1.0 [0.7, 1.6]<br />
No <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose<br />
dur<strong>in</strong>g labour and/or delivery 48/208 (23) 31/217 (14) 1.8 [1.1, 3.0] 1.8 [1.1, 3.0]<br />
a<br />
adjusted for maternal age and deprivation.<br />
6.3.5 Preconception c<strong>are</strong> <strong>in</strong> <strong>the</strong> 12 months prior to <strong>pregnancy</strong><br />
Specifi c preconception c<strong>are</strong> factors, based on <strong>the</strong> medical records held by adult diabetes services<br />
or general practitioners, <strong>we</strong>re <strong>in</strong>vestigated for association with poor <strong>pregnancy</strong> outcome. The results<br />
<strong>are</strong> shown <strong>in</strong> table 6.5 and <strong>are</strong> discussed fur<strong>the</strong>r <strong>in</strong> chapter 8. These fi nd<strong>in</strong>gs <strong>we</strong>re dependent on<br />
documentation <strong>in</strong> <strong>the</strong> medical records, and poor documentation by health professionals of <strong>the</strong> c<strong>are</strong> and<br />
advice given to women may have <strong>in</strong>fl uenced <strong>the</strong> app<strong>are</strong>nt association with poor <strong>pregnancy</strong> outcome.<br />
28
Table 6.5<br />
Association of specifi c preconception c<strong>are</strong> factors <strong>in</strong> women with type 1 and type 2 diabetes with poor <strong>pregnancy</strong><br />
outcome<br />
Preconception c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
[95% CI]<br />
No contraceptive advice provided<br />
before <strong>pregnancy</strong> 28/85 (33) 19/83 (23) 1.7 [0.8, 3.3] 1.7 [0.8, 3.5]<br />
No discussion of <strong>the</strong> follow<strong>in</strong>g<br />
specifi c diabetes issues:<br />
Alcohol <strong>in</strong>take 31/70 (44) 19/66 (29) 2.0 [1.0, 4.1] 2.5 [1.1, 5.4]<br />
Diet 20/103 (19) 12/100 (12) 1.8 [0.8, 3.9] 1.8 [0.8, 4.1]<br />
Poor glycaemic control 18/118 (15) 14/117 (12) 1.3 [0.6, 2.8] 1.2 [0.5, 2.5]<br />
Ret<strong>in</strong>opathy 25/83 (30) 25/96 (26) 1.2 [0.6, 2.4] 1.1 [0.6, 2.3]<br />
Nephropathy 28/74 (38) 29/76 (38) 1.0 [0.5, 1.9] 0.8 [0.4, 1.7]<br />
Hypertension 27/71 (38) 23/75 (31) 1.4 [0.7, 2.8] 1.1 [0.5, 2.3]<br />
No discussion of <strong>the</strong> follow<strong>in</strong>g <strong>pregnancy</strong> issues:<br />
Increased diabetes surveillance 13/123 (11) 7/124 (6) 2.0 [0.8, 5.2] 1.7 [0.6, 4.5]<br />
Increased <strong>pregnancy</strong> surveillance 13/117 (11) 8/124 (6) 1.8 [0.7, 4.6] 1.5 [0.6, 4.0]<br />
Increased risk of <strong>in</strong>duction 21/83 (25) 14/110 (13) 2.3 [1.1, 5.0] 2.2 [1.0, 4.9]<br />
Possible caes<strong>are</strong>an section 20/95 (21) 11/110 (10) 2.4 [1.1, 5.4] 2.4 [1.0, 5.8]<br />
Fetal risks <strong>in</strong> diabetic <strong>pregnancy</strong> 17/98 (17) 7/114 (6) 3.2 [1.3, 8.2] 2.9 [1.1, 8.2]<br />
No dietetic review 46/129 (36) 42/135 (61) 1.2 [0.7, 2.1] 1.2 [0.7, 2.1]<br />
No assessment of <strong>the</strong> follow<strong>in</strong>g diabetes<br />
complications <strong>in</strong> <strong>the</strong> 12 months prior to<br />
<strong>pregnancy</strong>:<br />
Basel<strong>in</strong>e ret<strong>in</strong>al exam<strong>in</strong>ation 36/141 (26) 18/137 (13) 2.3 [1.2, 4.3] 2.3 [1.2, 4.5]<br />
Basel<strong>in</strong>e test of renal function 26/130 (20) 15/133 (11) 2.0 [1.0, 3.9] 2.0 [0.9, 4.3]<br />
Assessment of album<strong>in</strong>uria 41/116 (35) 30/109 (28) 1.4 [0.8, 2.6] 1.5 [0.8, 2.8]<br />
Assessment of suboptimal preconception c<strong>are</strong><br />
(exclud<strong>in</strong>g glycaemic control) 116/133 (87) 80/134 (60) 4.6 [2.4, 8.8] 5.2 [2.7, 10.1]<br />
a<br />
adjusted for maternal age and deprivation.<br />
6.3.6 <strong>Diabetes</strong> c<strong>are</strong> (exclud<strong>in</strong>g glycaemic control)<br />
<strong>Diabetes</strong> c<strong>are</strong> <strong>in</strong> <strong>the</strong> enquiry referred to monitor<strong>in</strong>g for diabetes complications, <strong>in</strong>clud<strong>in</strong>g ret<strong>in</strong>al<br />
assessments and tests of renal function. F<strong>in</strong>d<strong>in</strong>gs <strong>are</strong> shown <strong>in</strong> table 6.6 and <strong>are</strong> discussed fur<strong>the</strong>r <strong>in</strong><br />
Chapter 9.<br />
29
Factors associated with poor <strong>pregnancy</strong> outcome<br />
<strong>in</strong> women with type 1 and type 2 diabetes<br />
Table 6.6<br />
Association of diabetes c<strong>are</strong> factors (exclud<strong>in</strong>g glycaemic control) <strong>in</strong> women with type 1 and type 2 diabetes,<br />
with poor <strong>pregnancy</strong> outcome<br />
<strong>Diabetes</strong> c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
[95% CI]<br />
No ret<strong>in</strong>al assessment dur<strong>in</strong>g fi rst trimester<br />
or at book<strong>in</strong>g if later 70/194 (36) 49/183 (27) 1.5 [1.0, 2.4] 1.4 [0.9, 2.2]<br />
No referral to ophthalmologist<br />
(if ret<strong>in</strong>opathy present) 10/45 (22) 21/44 (48) 0.3 [0.1, 0.8] 0.2 [0.1, 0.7]<br />
No monitor<strong>in</strong>g for nephropathy 46/209 (22) 26/206 (13) 2.0 [1.2, 3.3] 1.9 [1.1, 3.3]<br />
No test of renal function<br />
(if nephropathy present) 12/26 (46) 5/14 (36) 1.5 [0.4, 6.0] 1.9 [0.3, 6.0]<br />
Assessment of suboptimal diabetes<br />
c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong> 146/204 (72) 118/204 (58) 1.8 [1.2, 2.8] 1.7 [1.1, 2.6]<br />
a<br />
adjusted for maternal age and deprivation.<br />
6.3.7 Maternity c<strong>are</strong><br />
The association of maternity c<strong>are</strong> factors with poor <strong>pregnancy</strong> outcome <strong>are</strong> shown <strong>in</strong> table 6.7. It is of<br />
concern that suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong> and suboptimal antenatal fetal surveillance of big<br />
babies <strong>we</strong>re associated with poor <strong>pregnancy</strong> outcome. This, toge<strong>the</strong>r with issues relat<strong>in</strong>g to discussion of<br />
mode and tim<strong>in</strong>g of delivery, <strong>are</strong> discussed fur<strong>the</strong>r <strong>in</strong> Chapter 9.<br />
Table 6.7<br />
Association of maternity c<strong>are</strong> factors <strong>in</strong> women with type 1 and type 2 diabetes with poor <strong>pregnancy</strong> outcome<br />
Maternity c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR<br />
[95% CI]<br />
Assessment of suboptimal fetal<br />
monitor<strong>in</strong>g (with antenatal evidence<br />
6/24 (25) 1/11 (9) 3.3 [0.3, 34.1] 2.3 [0.2, 26.3]<br />
of growth restricted baby)<br />
Assessment of suboptimal fetal<br />
monitor<strong>in</strong>g (with antenatal evidence<br />
35/52 (67) 27/73 (37) 3.5 [1.7, 7.4] 5.3 [2.4, 12.0]<br />
of fetal size > 90th centile)<br />
No discussion of mode and tim<strong>in</strong>g of delivery 15/178 (8) 4/202 (2) 4.6 [1.5, 14.2] 4.0 [1.2, 12.7]<br />
No adm<strong>in</strong>istration of antenatal corticosteroids b 14/41 (34) 12/33 (36) 0.9 [0.4, 2.4] 0.9 [0.3, 2.5]<br />
Assessment of suboptimal maternity<br />
c<strong>are</strong> dur<strong>in</strong>g <strong>the</strong> antenatal period 125/215 (58) 95/215 (44) 1.8 [1.2, 2.6] 1.9 [1.2, 2.8]<br />
Assessment of suboptimal maternity<br />
c<strong>are</strong> dur<strong>in</strong>g labour and delivery 78/199 (39) 72/213 (34) 1.3 [0.8, 1.9] 1.3 [0.8, 1.9]<br />
a<br />
adjusted for maternal age and deprivation.<br />
b<br />
Analysis restricted to babies deliver<strong>in</strong>g from 24+0 to 35+6 <strong>we</strong>eks gestation and exclud<strong>in</strong>g antepartum stillbirths.<br />
6.3.8 Postnatal c<strong>are</strong><br />
Although postnatal c<strong>are</strong> factors could not have been causative to poor <strong>pregnancy</strong> outcome, women who<br />
had a poor <strong>pregnancy</strong> outcome <strong>we</strong>re more likely to have suboptimal postnatal diabetes c<strong>are</strong> and no<br />
contraceptive advice before discharge from hospital (table 6.8). This is discussed fur<strong>the</strong>r <strong>in</strong> Chapter 9.<br />
30
Table 6.8<br />
Association of postnatal c<strong>are</strong> factors with poor <strong>pregnancy</strong> outcome <strong>in</strong> women with type 1 and type 2 diabetes<br />
Postnatal c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
[95% CI]<br />
No postnatal contraceptive advice 63/143 (44) 26/163 (16) 4.2 [2.4, 7.3] 4.2 [2.4, 7.4]<br />
No written plan for post-delivery<br />
diabetes management 31/184 (17) 25/188 (13) 1.3 [0.8, 2.3] 1.4 [0.8, 2.6]<br />
Assessment of suboptimal<br />
postnatal diabetes c<strong>are</strong> 133/203 (66) 106/211 (50) 1.9 [1.3, 2.8] 1.8 [1.2, 2.7]<br />
a<br />
adjusted for maternal age and deprivation.<br />
6.4 Conclusions<br />
The case-control analysis has noted a number of associations bet<strong>we</strong>en demographic, social and lifestyle<br />
factors and cl<strong>in</strong>ical c<strong>are</strong> with poor <strong>pregnancy</strong> outcome, and <strong>the</strong>se <strong>are</strong> discussed fur<strong>the</strong>r <strong>in</strong> <strong>the</strong> relevant<br />
chapters <strong>in</strong> this report. It should be noted that <strong>the</strong>se factors <strong>are</strong> based on documentation <strong>in</strong> <strong>the</strong> medical<br />
records and on panels’ assessment of behaviour or c<strong>are</strong>, which <strong>in</strong>troduce potential problems, fi rstly with<br />
<strong>the</strong> high proportion of miss<strong>in</strong>g results for some data items, and secondly with potential bias due to lack<br />
of bl<strong>in</strong>d<strong>in</strong>g of <strong>the</strong> panel assessors. There may also be confound<strong>in</strong>g factors and although attempts have<br />
been made to adjust for some of <strong>the</strong>se <strong>in</strong> <strong>the</strong> analysis, <strong>the</strong>re may still be o<strong>the</strong>r factors that have not been<br />
taken <strong>in</strong>to account. Overall, ho<strong>we</strong>ver, <strong>the</strong> fi nd<strong>in</strong>gs support <strong>the</strong> argument that preparation for <strong>pregnancy</strong>,<br />
glycaemic control, and <strong>the</strong> standard of preconception and <strong>pregnancy</strong> c<strong>are</strong> need to be improved if better<br />
<strong>pregnancy</strong> outcomes <strong>are</strong> to be achieved for women with diabetes.<br />
References<br />
1. Mac<strong>in</strong>tosh M, Flem<strong>in</strong>g K, Bailey J, Doyle P, Modder J, Acolet D, et al. Per<strong>in</strong>atal mortality and<br />
congenital anomalies <strong>in</strong> babies of women with type 1 or type 2 diabetes <strong>in</strong> England, Wales and<br />
Nor<strong>the</strong>rn Ireland: population based study. BMJ, Jul 22 2006 333 (7560):177.<br />
2. Evers I, de Valk H, Visser G. Risk of complications of <strong>pregnancy</strong> <strong>in</strong> women with type 1 diabetes:<br />
nationwide prospective study <strong>in</strong> <strong>the</strong> Ne<strong>the</strong>rlands. BMJ, Apr 17 2004 328(7445):915.<br />
3. Verheijen E, Critchley J, Whitelaw D, Tuffnell D. Outcomes of pregnancies <strong>in</strong> women with<br />
pre-exist<strong>in</strong>g type 1 or type 2 diabetes, <strong>in</strong> an ethnically mixed population. BJOG, Nov 2005<br />
112(11):1500-3.<br />
4. Jensen D, Damm P, Moelsted-Pedersen L, Ovesen P, Westergaard J, Moeller M, et al. Outcomes<br />
<strong>in</strong> type 1 diabetic pregnancies: a nationwide, population-based study. <strong>Diabetes</strong> C<strong>are</strong>, Dec 2004<br />
27(12):2819-23.<br />
5. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Per<strong>in</strong>atal Mortality Surveillance, 2004: England,<br />
Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2006.<br />
6. Coll<strong>in</strong>gwood Bakeo A. Investigat<strong>in</strong>g variations <strong>in</strong> <strong>in</strong>fant mortality <strong>in</strong> England and Wales by mo<strong>the</strong>r’s<br />
country of birth, 1983 – 2001. Paediatric and Per<strong>in</strong>atal Epidemiology, Mar 2006 20(2):127-39.<br />
31
7. Social and lifestyle issues<br />
Learn<strong>in</strong>g po<strong>in</strong>ts<br />
• Women with diabetes do not appear to be adequately prep<strong>are</strong>d for <strong>pregnancy</strong>.<br />
• Two thirds of women with diabetes had suboptimal glycaemic control before and dur<strong>in</strong>g <strong>the</strong> fi rst<br />
trimester of <strong>pregnancy</strong>.<br />
• Suboptimal glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong>, and a suboptimal approach of <strong>the</strong><br />
woman to manag<strong>in</strong>g her diabetes, <strong>we</strong>re associated with poor <strong>pregnancy</strong> outcome.<br />
• The ma<strong>in</strong> underly<strong>in</strong>g issues for women with diabetes <strong>we</strong>re:<br />
- non-attendance at planned appo<strong>in</strong>tments<br />
- non-adherence to medical advice about diabetes management<br />
- unplanned <strong>pregnancy</strong><br />
- social factors <strong>in</strong>clud<strong>in</strong>g language diffi culties and domestic circumstances.<br />
7.1 Introduction<br />
The prevalence of diabetes <strong>in</strong> <strong>the</strong> UK is <strong>in</strong>creas<strong>in</strong>g, with an <strong>in</strong>creas<strong>in</strong>g number of young people be<strong>in</strong>g<br />
diagnosed. 1-3 There <strong>are</strong> an estimated 131 000 women diagnosed with diabetes of childbear<strong>in</strong>g age <strong>in</strong><br />
England (<strong>Diabetes</strong> UK, personal communication) . The CEMACH report on 3808 pregnancies to women<br />
with type 1 and type 2 diabetes has shown that women <strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland <strong>are</strong> poorly<br />
prep<strong>are</strong>d for <strong>pregnancy</strong>. 4<br />
This chapter exam<strong>in</strong>es some of <strong>the</strong> underly<strong>in</strong>g issues that <strong>we</strong>re identifi ed dur<strong>in</strong>g panel reviews of<br />
442 s<strong>in</strong>gleton pregnancies to women with diabetes <strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland.<br />
7.2 Preparation for <strong>pregnancy</strong><br />
Development of <strong>the</strong> fetal organs occurs dur<strong>in</strong>g <strong>the</strong> fi rst three months of <strong>pregnancy</strong>, and <strong>the</strong>re is evidence<br />
that good glycaemic control <strong>in</strong> <strong>the</strong> preconception period and dur<strong>in</strong>g <strong>the</strong> fi rst trimester of <strong>pregnancy</strong><br />
decreases <strong>the</strong> risk of fetal congenital anomaly and miscarriage. 5-7 Women with diabetes of childbear<strong>in</strong>g<br />
age need to use an effective and reliable method of contraception to avoid unplanned <strong>pregnancy</strong>, and it<br />
is recommended that women plann<strong>in</strong>g a <strong>pregnancy</strong> should cont<strong>in</strong>ue contraception until good glycaemic<br />
control has been achieved. 8 In addition, it has been shown that high dose (5mg) folic acid commenced<br />
before <strong>pregnancy</strong> decreases <strong>the</strong> risk of fetal neural tube defects <strong>in</strong> high risk populations 9 and this is<br />
recommended for women with diabetes. 1,10 Smok<strong>in</strong>g <strong>in</strong>creases <strong>the</strong> risk of diabetes vascular complications<br />
and placental <strong>in</strong>suffi ciency, and women should be advised and encouraged to stop smok<strong>in</strong>g.<br />
7.2.1 Enquiry fi nd<strong>in</strong>gs<br />
Less than half (41%, 158/384) of women <strong>in</strong> <strong>the</strong> enquiry (35% of 197 cases a and 48% of 187 controls b )<br />
<strong>we</strong>re documented to have planned <strong>the</strong>ir current <strong>pregnancy</strong>, comp<strong>are</strong>d to a planned <strong>pregnancy</strong> rate of 58%<br />
<strong>in</strong> 2001-02 <strong>in</strong> <strong>the</strong> general maternity population. 11 T<strong>we</strong>nty seven percent (107/32) of women (19% of 196<br />
cases and 36% of 196 controls) <strong>we</strong>re documented to have been us<strong>in</strong>g any form of contraception <strong>in</strong> <strong>the</strong><br />
12 months before conception. T<strong>we</strong>nty seven percent of 380 women <strong>we</strong>re documented to have commenced<br />
32
folic acid before <strong>pregnancy</strong> (19% of 193 cases and 35% of 187 controls). This is comparable to <strong>the</strong> general<br />
maternity population <strong>in</strong> <strong>the</strong> UK, where <strong>the</strong> uptake of folic acid has been shown to range from less than 10%<br />
to 50% <strong>in</strong> different studies. 12 Only 33 women <strong>we</strong>re documented to be on high dose (5mg daily) folic acid.<br />
Women who did not have a record of any form of contraceptive use <strong>in</strong> <strong>the</strong> 12 months before <strong>pregnancy</strong><br />
<strong>we</strong>re more likely to have a poor <strong>pregnancy</strong> outcome (OR 2.3, 95% CI 1.3 - 4.0 adjusted for maternal age<br />
and deprivation, see Chapter 6). In <strong>the</strong> additional case-control analysis (see Appendices C, D and E) <strong>the</strong><br />
specifi c association was with fetal or neonatal death from 20 <strong>we</strong>eks gestation and not with fetal congenital<br />
anomaly. This suggests that <strong>the</strong>se women <strong>we</strong>re not aw<strong>are</strong> of <strong>the</strong> importance of us<strong>in</strong>g contraception until<br />
optimal glycaemic control had been achieved prior to conception, and may have been unaw<strong>are</strong> of <strong>the</strong><br />
importance of good <strong>pregnancy</strong> preparation <strong>in</strong> order to reduce <strong>the</strong> risks of adverse <strong>pregnancy</strong> outcomes.<br />
T<strong>we</strong>nty eight percent (107/386) of women with diabetes <strong>we</strong>re documented as smok<strong>in</strong>g before<br />
<strong>pregnancy</strong> (32% of 197 cases and 23% of 189 controls). This comp<strong>are</strong>s to a rate of 35% <strong>in</strong> <strong>the</strong> general<br />
maternity population. 11<br />
7.3 Panel assessment of glycaemic control<br />
Optimal glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong> is one of <strong>the</strong> ma<strong>in</strong> pr<strong>in</strong>ciples of management for<br />
women with pre-exist<strong>in</strong>g diabetes, as this decreases <strong>the</strong> risk of adverse <strong>pregnancy</strong> outcomes. 5-7 This<br />
can be challeng<strong>in</strong>g for women who already have to cope with <strong>the</strong> ongo<strong>in</strong>g demands of <strong>the</strong>ir diabetes,<br />
and health professionals and women need to work <strong>in</strong> partnership to achieve good control.<br />
The guidance given to enquiry panels was that optimal glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong><br />
referred to an HbA1c of less than 7%. Ho<strong>we</strong>ver, it was emphasised that panel assessors may have<br />
additional <strong>in</strong>formation available to <strong>the</strong>m at enquiry, and <strong>in</strong> this case should base <strong>the</strong>ir assessment on<br />
all <strong>the</strong> available <strong>in</strong>formation.<br />
Enquiry panels assessed that 64% of 440 women (74% of 222 cases and 53% of 218 of controls) had<br />
suboptimal glycaemic control before <strong>pregnancy</strong> and 66% of 439 women (77% of 222 cases and 54% of<br />
217 controls) had suboptimal control dur<strong>in</strong>g <strong>the</strong> fi rst trimester of <strong>pregnancy</strong>. After <strong>the</strong> fi rst trimester and up<br />
to labour and delivery, this decreased to 51% of 443 women (68% of 215 cases and 35% of 218 controls)<br />
of women with cont<strong>in</strong>u<strong>in</strong>g pregnancies. Suboptimal glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong> was<br />
associated with poor <strong>pregnancy</strong> outcome (OR 3.9, 95% CI 2.2 - 7.0 pre-<strong>pregnancy</strong>; OR 3.4, 95%<br />
CI 2.1 - 5.7 <strong>in</strong> fi rst trimester; OR 5.2 , 95% CI 3.3 - 8.2 after fi rst trimester (all OR adjusted for maternal<br />
age and deprivation, see Chapter 6).<br />
a<br />
In this chapter, a case refers to a woman who had a poor <strong>pregnancy</strong> outcome, defi ned as a s<strong>in</strong>gleton baby with a major congenital<br />
anomaly who delivered at any gestation and/or a baby who died from 20 <strong>we</strong>eks gestation up to 28 days after delivery.<br />
b<br />
In this chapter, a control refers to a woman who had a good <strong>pregnancy</strong> outcome, defi ned as a s<strong>in</strong>gleton baby without a congenital<br />
anomaly who survived to day 28 after delivery.<br />
33
Social and lifestyle issues<br />
7.3.1 Panel comments on suboptimal preconception glycaemic control<br />
Enquiry panels made a total of 334 comments for 280 women with suboptimal preconception glycaemic<br />
control. The majority of <strong>the</strong>se comments related to social and lifestyle issues (table 7.1). T<strong>we</strong>nty percent<br />
of women with suboptimal glycaemic control did not attend planned appo<strong>in</strong>tments, Ten percent had an<br />
unplanned <strong>pregnancy</strong> and 19% did not follow advice about <strong>the</strong> management of <strong>the</strong>ir diabetes. Eleven<br />
percent of women <strong>we</strong>re socially vulnerable (ma<strong>in</strong>ly language diffi culties and domestic circumstances)<br />
or had erratic or busy lifestyles.<br />
Table 7.1<br />
Panel comments on suboptimal preconception glycaemic control (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation<br />
of free text)<br />
Women with suboptimal preconception<br />
glycaemic control<br />
Good <strong>pregnancy</strong> outcome<br />
(N=115)<br />
Poor <strong>pregnancy</strong> outcome<br />
(N=165)<br />
No. of comments % of women No. of comments % of women<br />
Total comments a 68 119<br />
Medical, social and lifestyle factors b 32 - 48 -<br />
Unplanned <strong>pregnancy</strong> 12 10 16 10<br />
Social vulnerability or lifestyle problems 9 8 22 13<br />
Medical factors 11 10 9 5<br />
Poor education / understand<strong>in</strong>g<br />
of diabetes<br />
0 - 1 1<br />
Woman did not attend appo<strong>in</strong>tments 14 12 41 25<br />
Non adherence to diet, HBGM c<br />
or <strong>in</strong>sul<strong>in</strong> 22 19 30 18<br />
a<br />
There <strong>we</strong>re 81 additional comments where <strong>the</strong> issues <strong>we</strong>re not described by panels; 18 comments where <strong>the</strong>re was a lack of<br />
preconception c<strong>are</strong> with <strong>the</strong> reason be<strong>in</strong>g unclear to panels; and 48 comments about cl<strong>in</strong>ical c<strong>are</strong>. These comments <strong>are</strong> not<br />
<strong>in</strong>cluded <strong>in</strong> <strong>the</strong> table.<br />
b<br />
A s<strong>in</strong>gle woman could have more than one comment <strong>in</strong> <strong>the</strong> medical, social and lifestyle category, <strong>the</strong>refore % of women calculated<br />
only for <strong>in</strong>dividual factors.<br />
c<br />
Home blood glucose monitor<strong>in</strong>g.<br />
7.3.2 Panel comments on suboptimal glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong><br />
Panels made a total of 154 comments about social and lifestyle issues <strong>in</strong> <strong>the</strong> fi rst trimester and 94<br />
comments about social and lifestyle issues <strong>in</strong> <strong>the</strong> second trimester . The ma<strong>in</strong> issues <strong>we</strong>re non-adherence<br />
to medical advice and failure to attend planned appo<strong>in</strong>tments. ‘Medical, lifestyle or social factors’ <strong>in</strong>cluded<br />
concerns about erratic lifestyles and social problems (table 7.2).<br />
34
Table 7.2<br />
Panel comments on social and lifestyle issues underly<strong>in</strong>g suboptimal glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong> <strong>in</strong> women<br />
with pre-exist<strong>in</strong>g diabetes (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation of free text)<br />
Women assessed to have suboptimal<br />
glycaemic control <strong>in</strong> <strong>the</strong> 1st trimester<br />
Good <strong>pregnancy</strong><br />
outcome<br />
(N=118)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Poor <strong>pregnancy</strong><br />
outcome<br />
(N=171)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Women assessed to have suboptimal<br />
glycaemic control after <strong>the</strong> 1st trimester<br />
Good <strong>pregnancy</strong><br />
outcome<br />
(N=76)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Poor <strong>pregnancy</strong><br />
outcome<br />
(N=146)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Total<br />
comments* 57 - 97 - 27 - 67 -<br />
Non adherence<br />
to medical 19 16 36 21 11 14 26 18<br />
advice<br />
Medical,<br />
lifestyle or 8 7 9 5 4 5 11 8<br />
social factors<br />
Duration and<br />
severity of 6 5 8 5 4 5 10 7<br />
diabetes<br />
Woman did not<br />
attend planned 10 8 21 12 5 7 14 10<br />
appo<strong>in</strong>tments<br />
Actively chose<br />
not to follow 1 1 3 2 3 4 6 4<br />
medical advice<br />
Late booker 6 5 14 8 0 0 0 0<br />
Unplanned<br />
<strong>pregnancy</strong> 7 6 6 4 0 0 0 0<br />
* There <strong>we</strong>re 178 comments made about cl<strong>in</strong>ical c<strong>are</strong> issues; <strong>the</strong>se comments <strong>are</strong> not <strong>in</strong>cluded <strong>in</strong> this table but <strong>are</strong> <strong>in</strong>cluded <strong>in</strong><br />
table 9.1 (Chapter 9).<br />
7.4 Women’s approach to manag<strong>in</strong>g <strong>the</strong>ir diabetes<br />
Women with diabetes may have an <strong>in</strong>creased burden on <strong>the</strong>ir work and personal lives both before and<br />
dur<strong>in</strong>g <strong>pregnancy</strong>, due to <strong>the</strong> additional issues which arise at this time. This can sometimes lead to a<br />
suboptimal approach to manag<strong>in</strong>g <strong>the</strong>ir diabetes.<br />
7.4.1 Panel assessment of women’s approach to manag<strong>in</strong>g <strong>the</strong>ir diabetes<br />
Enquiry panels assessed that 51% of 434 women had a suboptimal approach to manag<strong>in</strong>g <strong>the</strong>ir diabetes<br />
before <strong>pregnancy</strong> (62% of 216 cases and 40% of 218 controls) and 40% of 434 women had a suboptimal<br />
approach to manag<strong>in</strong>g <strong>the</strong>ir diabetes dur<strong>in</strong>g <strong>pregnancy</strong> (55% of 216 cases and 26% of 218 controls).<br />
A suboptimal approach of <strong>the</strong> woman to manag<strong>in</strong>g her diabetes ei<strong>the</strong>r before or dur<strong>in</strong>g <strong>pregnancy</strong> was<br />
associated with poor <strong>pregnancy</strong> outcome (OR 4.9, 95% CI 2.7 - 8.8 and OR 3.9 , 95% CI 2.5 - 6.1<br />
respectively, adjusted for maternal age and deprivation, see Chapter 6).<br />
35
Social and lifestyle issues<br />
7.4.2 Panel comments on suboptimal approach of <strong>the</strong> woman to manag<strong>in</strong>g her diabetes<br />
Panels made 283 comments for 222 women before <strong>pregnancy</strong> and 199 comments for 174 women dur<strong>in</strong>g<br />
<strong>pregnancy</strong> (table 7.3). The ma<strong>in</strong> issues <strong>we</strong>re non-adherence to medical advice, non-attendance at planned<br />
appo<strong>in</strong>tments, and social factors <strong>in</strong>clud<strong>in</strong>g unplanned <strong>pregnancy</strong>, poor motivation and poor understand<strong>in</strong>g<br />
of diabetes.<br />
Table 7.3<br />
Panel comments on suboptimal approach of <strong>the</strong> woman to manag<strong>in</strong>g her diabetes (table conta<strong>in</strong>s <strong>in</strong>formation<br />
follow<strong>in</strong>g categorisation of free text)<br />
Women assessed to have suboptimal<br />
approach to diabetes management before<br />
<strong>pregnancy</strong><br />
Good <strong>pregnancy</strong><br />
outcome<br />
(N=88)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Poor <strong>pregnancy</strong><br />
outcome<br />
(N=134)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Women assessed to have suboptimal<br />
approach to diabetes management dur<strong>in</strong>g<br />
<strong>pregnancy</strong><br />
Good <strong>pregnancy</strong><br />
outcome<br />
(N=56)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Poor <strong>pregnancy</strong><br />
outcome<br />
(N=118)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Total comments* 110 167 65 106<br />
Medical,<br />
lifestyle, social 42 - 65 - 16 - 38 -<br />
factors †<br />
Unplanned<br />
<strong>pregnancy</strong> or no 14 16 22 16 1 2 2 2<br />
contraception<br />
Poorly motivated 8 9 8 6 4 7 2 2<br />
Poor education or<br />
understand<strong>in</strong>g of 3 3 6 4 3 5 4 3<br />
diabetes<br />
O<strong>the</strong>r social or<br />
lifestyle factors 15 17 29 22 4 7 16 14<br />
Medical factors 2 2 0 - 4 7 14 12<br />
Non-adherence to<br />
medical advice 32 36 45 34 27 48 38 32<br />
Woman did<br />
not attend<br />
25 28 46 34 13 23 18 15<br />
appo<strong>in</strong>tments<br />
Woman actively<br />
chose not to<br />
follow medical<br />
advice<br />
8 9 7 5 7 13 9 8<br />
Duration or<br />
severity of<br />
diabetes<br />
3 3 4 3 2 4 3 3<br />
* There <strong>we</strong>re 6 comments on cl<strong>in</strong>ical c<strong>are</strong> before <strong>pregnancy</strong> and 28 comments on cl<strong>in</strong>ical c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong>; <strong>the</strong>se comments <strong>are</strong><br />
not <strong>in</strong>cluded <strong>in</strong> <strong>the</strong> table.<br />
†<br />
A s<strong>in</strong>gle woman could have more than one comment <strong>in</strong> <strong>the</strong> medical, social and lifestyle category, <strong>the</strong>refore % of women calculated<br />
only for <strong>in</strong>dividual factors.<br />
36
7.5 Conclusions<br />
One of <strong>the</strong> key fi nd<strong>in</strong>gs of <strong>the</strong> previous CEMACH report 4 was that women with diabetes <strong>in</strong> England, Wales<br />
and Nor<strong>the</strong>rn Ireland <strong>are</strong> poorly prep<strong>are</strong>d for <strong>pregnancy</strong>, and many enter <strong>pregnancy</strong> with poor glycaemic<br />
control. Fur<strong>the</strong>r exploration of <strong>the</strong> underly<strong>in</strong>g issues for <strong>the</strong> 442 women <strong>in</strong> <strong>the</strong> enquiry has confi rmed that<br />
two thirds of women had suboptimal glycaemic control before and <strong>in</strong> early <strong>pregnancy</strong>, as assessed by<br />
enquiry panels. It is of concern that <strong>the</strong> ma<strong>in</strong> underly<strong>in</strong>g factors appe<strong>are</strong>d to be social issues and women’s<br />
approach to manag<strong>in</strong>g <strong>the</strong>ir diabetes.<br />
Suboptimal glycaemic control and a suboptimal approach by women to diabetes management is<br />
associated with poor <strong>pregnancy</strong> outcome (see Chapter 6), and <strong>the</strong> above issues need to be considered<br />
as a matter of urgency if education programmes and preconception services <strong>are</strong> to reach those women<br />
who need support to improve <strong>the</strong>ir <strong>pregnancy</strong> outcomes. Fur<strong>the</strong>r research is needed <strong>in</strong>to <strong>the</strong> possible<br />
social, cultural and emotional factors affect<strong>in</strong>g women’s preconception behaviour and how <strong>the</strong>se can<br />
be addressed. Primary and secondary c<strong>are</strong> providers <strong>are</strong> likely to need to work toge<strong>the</strong>r with local<br />
communities <strong>in</strong> order to engage with women with diabetes before <strong>the</strong>y enter <strong>pregnancy</strong>.<br />
Some quotes from <strong>the</strong> panel discussions<br />
Social and lifestyle issues:<br />
• 'HbA1c 8.8. Communication problems (husband acted as <strong>in</strong>terpreter). Cultural problems: woman<br />
fast<strong>in</strong>g dur<strong>in</strong>g festivals. Suspected educational problems.'<br />
• 'HbA1c 9.3 at 4 <strong>we</strong>eks. Patient not monitor<strong>in</strong>g. Overseas refugee, language diffi culties' .<br />
• ‘Lifestyle – hours of work - busy life.’<br />
• 'Her obesity, social factors 'domestic turmoil'. No evidence of regular diabetes review - seems to<br />
have lost contact with professionals.'<br />
• 'Unplanned <strong>pregnancy</strong>' .<br />
• Non-adherence to medical advice:<br />
• 'patient did not take dietary recommendations and did not take <strong>in</strong>sul<strong>in</strong> regularly' .<br />
• 'HbA1c pre-<strong>pregnancy</strong> range 11.5 - 7.4%, but non-compliant with diet, forgets <strong>in</strong>jection, regular<br />
hypo's, lack of carbohydrates.'<br />
• 'patient did not test her levels for optimal c<strong>are</strong> (average three per <strong>we</strong>ek)' .<br />
Non-attendance at planned appo<strong>in</strong>tments:<br />
• 'No pre-<strong>pregnancy</strong> c<strong>are</strong>. 5 appo<strong>in</strong>tments sent by midwife and DSN. Not check<strong>in</strong>g blood sugars' .<br />
• 'Inconsistent attendances at cl<strong>in</strong>ic. ? Lifestyle problems - s<strong>in</strong>gle mo<strong>the</strong>r with 2 small children' .<br />
• HBA1c 10.4 at book<strong>in</strong>g, brittle diabetic disease process. Woman was poor attender. Diabetic<br />
coma three months prior to <strong>pregnancy</strong>' .<br />
37
Social and lifestyle issues<br />
7.6 Recommendations<br />
Cl<strong>in</strong>ical<br />
1. Preconception and maternity services related to <strong>pregnancy</strong> should be easily accessible and<br />
responsive to all women with diabetes, and provide appropriate c<strong>are</strong> and <strong>in</strong>formation.<br />
2. There should be mechanisms <strong>in</strong> place to identify vulnerable communities and <strong>in</strong>dividuals, so that<br />
additional services can be provided as appropriate to women of childbear<strong>in</strong>g age with diabetes,<br />
<strong>the</strong>reby ensur<strong>in</strong>g optimal preconception c<strong>are</strong>.<br />
3. Providers of diabetes c<strong>are</strong> should develop educational strategies that will enable all women of<br />
childbear<strong>in</strong>g age with diabetes to prep<strong>are</strong> adequately for <strong>pregnancy</strong> .<br />
Audit and research<br />
4. Research should be carried out to:<br />
• identify <strong>the</strong> barriers to access<strong>in</strong>g preconception c<strong>are</strong><br />
• identify possible strategies to support self-c<strong>are</strong> and <strong>pregnancy</strong> plann<strong>in</strong>g by women with diabetes.<br />
References<br />
1. National Service Framework for <strong>Diabetes</strong> (England) Standards. Department of Health: The<br />
Stationery Offi ce: London 2001.<br />
2. Newham A, Ryan R. Prevalence of diagnosed diabetes mellitus <strong>in</strong> general practice <strong>in</strong> England and<br />
Wales, 1994 to 1998. Health Statistics Quarterly 14 Summer 2002.<br />
3. The emergence of type 2 diabetes <strong>in</strong> childhood. Ehtisham S. Annals of Cl<strong>in</strong>ical Biochemistry 41(Pt1),<br />
Jan 2004: 10-6.<br />
4. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Pregnancy <strong>in</strong> women with type 1 and<br />
type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
5. Pregnancy outcomes <strong>in</strong> <strong>the</strong> <strong>Diabetes</strong> Complications Trial. The <strong>Diabetes</strong> Control and Complications<br />
Trial Research Group. Am J Obstet Gynecol; 1996 174: 1343-53.<br />
6. Suhonen L, Hiilesmaa V, Teramo K. Glycaemic control dur<strong>in</strong>g early <strong>pregnancy</strong> and fetal<br />
malformations <strong>in</strong> women with type 1 diabetes mellitus.. Diabetologia 2000; 43:79-82.<br />
7. Kitzmiller JL, Gav<strong>in</strong> LA, G<strong>in</strong> GD et al. Preconception c<strong>are</strong> of diabetes. Glycemic control prevents<br />
congenital anomalies. JAMA: 1991 265: 731-6.<br />
8. <strong>Diabetes</strong> UK C<strong>are</strong> Recommendation. Preconception c<strong>are</strong> for women with diabetes.<br />
[http://www.diabetes.org.uk/About_us/Our_Views/C<strong>are</strong>_recommendations/Preconception_c<strong>are</strong>_<br />
for_women_with_diabetes/] accessed 9 December 2006.<br />
9. Lumley J, Watson L, Watson M, Bo<strong>we</strong>r C. Periconceptional supplementation with folate and/or<br />
multivitam<strong>in</strong>s for prevent<strong>in</strong>g neural tube defects. Cochrane Pregnancy and Childbirth Group.<br />
Cochrane Database of Systematic Reviews, 2006 3.<br />
10. <strong>Diabetes</strong> UK C<strong>are</strong> Recommendation. Folic acid supplementation <strong>in</strong> <strong>pregnancy</strong>. June 2005<br />
[http://www.diabetes.org.uk/About_us/Our_Views/C<strong>are</strong>_recommendations/Folic_acid/<br />
supplementation_<strong>in</strong>_<strong>pregnancy</strong>/] accessed 9 December 2006.<br />
38
11.Dex S, Hea<strong>the</strong>r J (eds). Millennium Cohort Study First Survey: a user’s guide to <strong>in</strong>itial fi nd<strong>in</strong>gs.<br />
Centre for Longitud<strong>in</strong>al Studies: London; 2004.<br />
12. Ray JG, S<strong>in</strong>gh G, Burrows RF. Evidence for suboptimal use of periconceptional folic acid<br />
supplements globally. BJOG 2004;111:399-408.<br />
Commentary<br />
Kirsty Samuel<br />
CEMACH lay panel assessor, Legal assessor, woman with type 1 diabetes and mo<strong>the</strong>r of two children.<br />
As a lay panel assessor <strong>in</strong> <strong>the</strong> CEMACH diabetes enquiry, a woman with diabetes and a mo<strong>the</strong>r of two<br />
children, I feel this chapter highlights a number of important <strong>are</strong>as <strong>in</strong> expla<strong>in</strong><strong>in</strong>g <strong>the</strong> unacceptably high<br />
number of adverse <strong>pregnancy</strong> outcomes for women with diabetes. Ho<strong>we</strong>ver it is <strong>the</strong> reasons beh<strong>in</strong>d <strong>the</strong><br />
fi gures that <strong>are</strong> of relevance <strong>in</strong> go<strong>in</strong>g forward. Why is suboptimal glycaemic control before and dur<strong>in</strong>g<br />
<strong>pregnancy</strong> so common and why is <strong>the</strong> woman’s approach to manag<strong>in</strong>g her diabetes less than ideal?<br />
These two questions <strong>are</strong>, <strong>in</strong> my op<strong>in</strong>ion, <strong>in</strong>extricably l<strong>in</strong>ked. The ans<strong>we</strong>r lies <strong>in</strong> <strong>the</strong> lack of accessible<br />
diabetes education and pre-<strong>pregnancy</strong> counsell<strong>in</strong>g. Women do not realise <strong>the</strong> importance of good control,<br />
and <strong>the</strong>refore do not ‘follow <strong>the</strong> advice given’, as it does not seem ei<strong>the</strong>r signifi cant or achievable to <strong>the</strong>m.<br />
Women with diabetes of childbear<strong>in</strong>g age need to be made more aw<strong>are</strong> of <strong>the</strong> potential impact of poor<br />
glycaemic control on <strong>pregnancy</strong> outcomes. This <strong>in</strong>formation should be made available before <strong>pregnancy</strong><br />
is seriously contemplated so that HbA1c levels can be reduced <strong>in</strong> preparation for <strong>pregnancy</strong> and<br />
unplanned pregnancies can be avoided. Women with type 2 diabetes particularly need to be targeted<br />
as many wrongly believe that <strong>the</strong>ir condition is less serious than type 1 diabetes and <strong>the</strong>refore will have<br />
less of an impact on <strong>pregnancy</strong>.<br />
In conjunction with this counsell<strong>in</strong>g, women need to be told of <strong>the</strong> tangible benefi ts of good control and<br />
<strong>the</strong> greatly <strong>in</strong>creased likelihood of hav<strong>in</strong>g a healthy baby, as fear of complications and congenital<br />
anomalies also has a part to play <strong>in</strong> non-attendance at cl<strong>in</strong>ics.<br />
As optimal glycaemic control is central to diabetes management <strong>in</strong> <strong>pregnancy</strong>, <strong>the</strong> means to achieve it has<br />
to be provided more effectively. The practicalities of atta<strong>in</strong><strong>in</strong>g near perfect control for such a long period of<br />
time <strong>are</strong> frighten<strong>in</strong>g and off-putt<strong>in</strong>g to many women, who fi nd good control hard enough to achieve without<br />
<strong>the</strong> additional burden of <strong>pregnancy</strong>. Realistic targets must be set, and ongo<strong>in</strong>g support and reassurance<br />
provided. Women need to know that <strong>the</strong>ir blood sugar levels will fl uctuate, and should be taught how<br />
to deal with <strong>the</strong>se fl uctuations <strong>in</strong> practical terms - how to adjust <strong>the</strong>ir <strong>in</strong>sul<strong>in</strong>, when and how to test <strong>the</strong>ir<br />
ur<strong>in</strong>e for ketones, and when to seek medical help. This will require a great deal of additional support and<br />
resources but by teach<strong>in</strong>g women how to manage <strong>the</strong>ir glycaemic control more effectively, <strong>the</strong>y will feel<br />
more <strong>in</strong>volved, more secure and more able to deal with <strong>the</strong> realities of <strong>pregnancy</strong>.<br />
Non-attendance at appo<strong>in</strong>tments will hopefully decrease <strong>in</strong> <strong>the</strong> future with <strong>in</strong>creased public knowledge and<br />
aw<strong>are</strong>ness of <strong>the</strong> importance of adher<strong>in</strong>g to medical advice. Ho<strong>we</strong>ver this, along with a fear of be<strong>in</strong>g ‘told<br />
off’ for fail<strong>in</strong>g to meet targets, is only one element of non-attendance at cl<strong>in</strong>ics. Practical problems such as<br />
39
Social and lifestyle issues<br />
long wait<strong>in</strong>g times, especially for women with children, must be addressed. If more women actually saw all<br />
<strong>the</strong> relevant physicians dur<strong>in</strong>g one cl<strong>in</strong>ic appo<strong>in</strong>tment this would reduce <strong>the</strong> time spent at <strong>the</strong> hospital, <strong>the</strong><br />
burden of multiple appo<strong>in</strong>tments, and would <strong>in</strong>crease women’s motivation to attend fur<strong>the</strong>r appo<strong>in</strong>tments.<br />
The fi nd<strong>in</strong>gs of this report all po<strong>in</strong>t to <strong>the</strong> need for a widespread diabetes education programme for<br />
all women with type 1 and type 2 diabetes of childbear<strong>in</strong>g age and <strong>the</strong> development of an effective<br />
preconception service. While many women <strong>are</strong> far from ‘perfect’ <strong>in</strong> terms of knowledge, attitude and<br />
co-operation, this can only change <strong>in</strong> a signifi cant way if <strong>the</strong> basic education and support systems <strong>are</strong><br />
<strong>in</strong> place. Women need to have <strong>the</strong> knowledge, and <strong>the</strong> means to achieve good control, so that <strong>the</strong>y<br />
can <strong>in</strong>crease <strong>the</strong>ir chances of a positive <strong>pregnancy</strong> outcome.<br />
40
8. Cl<strong>in</strong>ical c<strong>are</strong> issues: preconception<br />
Learn<strong>in</strong>g po<strong>in</strong>ts<br />
• In <strong>the</strong> CEMACH survey of maternity services, only 17% of maternity units <strong>in</strong> England, Wales and<br />
Nor<strong>the</strong>rn Ireland reported provid<strong>in</strong>g structured multidiscipl<strong>in</strong>ary preconception c<strong>are</strong> for women<br />
with diabetes. A quarter of women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re reported to have had preconception c<strong>are</strong><br />
at a multidiscipl<strong>in</strong>ary hospital cl<strong>in</strong>ic.<br />
• Two thirds of women <strong>in</strong> <strong>the</strong> enquiry had suboptimal preconception c<strong>are</strong>. One of <strong>the</strong> ma<strong>in</strong><br />
underly<strong>in</strong>g issues was failure of health professionals to provide appropriate c<strong>are</strong> such as<br />
preconception advice and higher dose folic acid. There was poor documentation of<br />
pre-<strong>pregnancy</strong> counsell<strong>in</strong>g.<br />
• Suboptimal preconception c<strong>are</strong> was associated with poor <strong>pregnancy</strong> outcome.<br />
8.1 Introduction<br />
Women with type 1 and type 2 diabetes represent a high-risk population dur<strong>in</strong>g <strong>pregnancy</strong>. Cl<strong>in</strong>icians have<br />
a responsibility to provide appropriate <strong>in</strong>formation, effective fetal and maternal surveillance, and timely<br />
health c<strong>are</strong> <strong>in</strong>terventions to achieve <strong>the</strong> <strong>best</strong> possible outcome for <strong>the</strong> woman and her baby. The <strong>Diabetes</strong><br />
National Service Framework (NSF) emphasises <strong>the</strong> importance of an effective multidiscipl<strong>in</strong>ary team, both<br />
to support and empo<strong>we</strong>r women to plan <strong>the</strong>ir pregnancies, optimise glycaemic control before conception<br />
and improve <strong>the</strong> quality of antenatal c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong>. 1 Ho<strong>we</strong>ver, <strong>the</strong> recent CEMACH descriptive<br />
study of 3808 pregnancies to women with type 1 and type 2 diabetes found that <strong>the</strong> majority of women<br />
with pre-exist<strong>in</strong>g diabetes <strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland <strong>are</strong> poorly prep<strong>are</strong>d for <strong>pregnancy</strong>. 2<br />
8.2 Preconception c<strong>are</strong> services<br />
The <strong>in</strong>creased risk of fetal congenital anomalies (with <strong>the</strong> ma<strong>in</strong> contributors be<strong>in</strong>g neural tube and cardiac<br />
defects) 3 and per<strong>in</strong>atal death <strong>in</strong> babies of women with pre-exist<strong>in</strong>g diabetes 2 can be m<strong>in</strong>imised by ensur<strong>in</strong>g<br />
good glycaemic control before and dur<strong>in</strong>g <strong>pregnancy</strong> 4 and by commenc<strong>in</strong>g high dose (5mg daily) folic acid<br />
before conception. 5<br />
Dur<strong>in</strong>g <strong>the</strong> CEMACH survey of maternity services (2004) 6 , only 17% of maternity units <strong>in</strong> England, Wales<br />
and Nor<strong>the</strong>rn Ireland reported that <strong>the</strong>y provided a multidiscipl<strong>in</strong>ary diabetes preconception service. The<br />
CEMACH descriptive study found that only 35% of women <strong>we</strong>re documented <strong>in</strong> <strong>the</strong> medical notes to have<br />
had pre-<strong>pregnancy</strong> counsell<strong>in</strong>g, with only a tenth of <strong>the</strong>se seen <strong>in</strong> a formal preconception cl<strong>in</strong>ic. 2 Dur<strong>in</strong>g <strong>the</strong><br />
enquiry, general practitioners and adult diabetes services <strong>we</strong>re also asked where preconception c<strong>are</strong> had<br />
been provided.<br />
41
Cl<strong>in</strong>ical c<strong>are</strong> issues: preconception<br />
8.2.1 Enquiry fi nd<strong>in</strong>gs<br />
28% of 442 women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re reported to have had preconception c<strong>are</strong> <strong>in</strong> <strong>the</strong> adult diabetes cl<strong>in</strong>ic<br />
and 15% with <strong>the</strong>ir general practitioner. 26% <strong>we</strong>re reported to have had c<strong>are</strong> at a hospital multidiscipl<strong>in</strong>ary<br />
cl<strong>in</strong>ic, although it was not specifi ed as to whe<strong>the</strong>r this <strong>in</strong>cluded a maternity component. For a fur<strong>the</strong>r 4%<br />
<strong>the</strong> venue of preconception c<strong>are</strong> was reported as ‘o<strong>the</strong>r’. Information about where preconception c<strong>are</strong> was<br />
provided was not available for 27% of 442 women.<br />
8.3 Pre-<strong>pregnancy</strong> counsell<strong>in</strong>g<br />
Women need to be aw<strong>are</strong> of <strong>the</strong> importance of <strong>pregnancy</strong> plann<strong>in</strong>g, good glycaemic control, and screen<strong>in</strong>g<br />
for specifi c diabetes complications before <strong>pregnancy</strong>, and should be supported to have a healthy diet<br />
and lifestyle. They <strong>are</strong> also more likely than <strong>the</strong> general maternity population to have medical <strong>in</strong>tervention<br />
dur<strong>in</strong>g <strong>pregnancy</strong> 1,2 and this may be perceived as negative or frighten<strong>in</strong>g unless it is discussed at an<br />
early stage. It is <strong>the</strong>refore important to discuss <strong>pregnancy</strong> risks, planned <strong>pregnancy</strong> surveillance and any<br />
possible <strong>in</strong>terventions, <strong>in</strong> <strong>the</strong> preconception period.<br />
For each woman, <strong>the</strong> general practitioner or adult diabetes service was asked if <strong>the</strong>re was documented<br />
evidence that <strong>the</strong>se issues had been discussed <strong>in</strong> <strong>the</strong> 12 months before <strong>pregnancy</strong>.<br />
8.3.1 Enquiry fi nd<strong>in</strong>gs<br />
Just over half (53%, 203/382) of women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re documented to have had a discussion<br />
about glycaemic control before <strong>pregnancy</strong>. Forty fi ve percent of 382 women <strong>we</strong>re recorded to have had<br />
a discussion about diet and 46% of 380 women to have been revie<strong>we</strong>d by a dietitian before <strong>pregnancy</strong>.<br />
Contraception was recorded to have been discussed with only 32% of 380 women. Documentation of<br />
discussion about specifi c diabetes complications ranged from 24% of 381 women for nephropathy to<br />
34% of 380 women for ret<strong>in</strong>opathy. Alcohol <strong>in</strong>take was discussed with just over a fi fth of women (table 8.1).<br />
Table 8.1<br />
<strong>Diabetes</strong>-related issues discussed with women before <strong>pregnancy</strong><br />
Specific issue discussed<br />
Women with poor<br />
<strong>pregnancy</strong> outcome<br />
n/N (%)<br />
Women with good<br />
<strong>pregnancy</strong> outcome<br />
n/N (%)<br />
All women <strong>in</strong> <strong>the</strong><br />
enquiry<br />
n/N (%)<br />
Glycaemic control 100/197 (51) 103/185 (56) 203/382 (53)<br />
Diet 83/196 (42) 88/185 (48) 171/381 (45)<br />
Ret<strong>in</strong>opathy 58/196 (30) 71/184 (39) 129/380 (34)<br />
Contraception 37/196 (19) 67/186 (36) 121/382 (32)<br />
Hypertension 44/196 (22) 52/184 (28) 96/380 (25)<br />
Nephropathy 46/196 (23) 47/185 (25) 93/381 (24)<br />
Alcohol <strong>in</strong>take 39/196 (20) 47/185 (25) 86/381 (23)<br />
Sixty percent of 381 women (54% of 191 cases a and 62% of 187 controls b ) <strong>we</strong>re recorded to have had a<br />
discussion about <strong>the</strong> need for <strong>in</strong>creased <strong>pregnancy</strong> surveillance. Ho<strong>we</strong>ver, discussion about fetal risks<br />
was documented for just 50% of 380 women (42% of 194 cases and 58% of 186 controls). The <strong>in</strong>creased<br />
42
chance of <strong>in</strong>duction of labour was recorded as discussed with 42% of 380 women (32% of 193 cases<br />
and 51% of 187 controls); and <strong>the</strong> possibility of caes<strong>are</strong>an delivery was recorded as discussed with 46%<br />
of 381 women (39% of 194 cases and 53% of 187 controls). Women who did not have a discussion<br />
about fetal risks and <strong>the</strong> possibility of caes<strong>are</strong>an delivery <strong>we</strong>re more likely to have a poor <strong>pregnancy</strong><br />
outcome (OR 2.9, 95% CI 1.1, 8.2; and 2.4, 95% CI 1.0– 5.8 respectively, adjusted for maternal age<br />
and deprivation, see Chapter 6). Additional case-control analysis (see Appendices C, D and E) sho<strong>we</strong>d<br />
that <strong>the</strong> specifi c association was with fetal or neonatal death from 20 <strong>we</strong>eks gestation and not with fetal<br />
congenital anomaly. Women who did not receive appropriate <strong>in</strong>formation about <strong>the</strong> risks and strategies of<br />
management before <strong>pregnancy</strong> may have been less aw<strong>are</strong> of <strong>the</strong> importance of optimal glycaemic control<br />
and <strong>the</strong> need for c<strong>are</strong>ful diabetes management through <strong>pregnancy</strong>.<br />
a<br />
In this chapter, a case refers to a woman who had a poor <strong>pregnancy</strong> outcome, defi ned as a s<strong>in</strong>gleton<br />
baby with a major congenital anomaly who delivered at any gestation and/or a baby who died from 20<br />
<strong>we</strong>eks gestation up to 28 days after delivery.<br />
b<br />
In this chapter, a control refers to a woman who had a good <strong>pregnancy</strong> outcome, defi ned as a s<strong>in</strong>gleton<br />
baby without a congenital anomaly who survived to day 28 after delivery.<br />
8.4 Screen<strong>in</strong>g for diabetes complications<br />
Pregnancy can cause deterioration of diabetes complications such as ret<strong>in</strong>opathy and renal disease,<br />
and screen<strong>in</strong>g for diabetes complications should be undertaken so that any necessary treatment can<br />
be provided prior to <strong>pregnancy</strong>.<br />
8.4.1 Enquiry fi nd<strong>in</strong>gs<br />
In <strong>the</strong> year before <strong>pregnancy</strong>, only 59% of 382 women (54% of 196 cases and 64% of 186 controls) had<br />
a ret<strong>in</strong>al exam<strong>in</strong>ation, and 58% of 382 women (53% of 195 cases and 63% of 187 controls) had a renal<br />
function test (creat<strong>in</strong><strong>in</strong>e, electrolytes and urea). Women who did not have a ret<strong>in</strong>al exam<strong>in</strong>ation <strong>in</strong> <strong>the</strong> year<br />
before <strong>pregnancy</strong> <strong>we</strong>re more likely to have a poor <strong>pregnancy</strong> outcome (OR 2.3, 95% CI 1.2 - 4.5, adjusted<br />
for maternal age and deprivation, see Chapter 6). In <strong>the</strong> additional case-control analysis (see Appendices<br />
C, D and E) <strong>the</strong> specifi c association was with fetal or neonatal death from 20 <strong>we</strong>eks gestation and not<br />
with fetal congenital anomaly. These women may have been less likely to access diabetes services before<br />
<strong>pregnancy</strong>, ei<strong>the</strong>r for cultural and societal reasons or due to <strong>in</strong>accessible services; and may not have been<br />
aw<strong>are</strong> of <strong>the</strong> importance of <strong>pregnancy</strong> preparation and <strong>the</strong> risks of diabetic <strong>pregnancy</strong>.<br />
8.5 Panel assessment of preconception c<strong>are</strong><br />
The enquiry panels assessed that 73% of 267 women (87% of 133 cases and 60% of 134 controls) had<br />
suboptimal preconception c<strong>are</strong>. Women hav<strong>in</strong>g suboptimal c<strong>are</strong> <strong>we</strong>re more likely to go on to have a poor<br />
<strong>pregnancy</strong> outcome (OR 5.2, 95% CI 2.7 - 10.1, adjusted for maternal age and deprivation, see Chapter 6).<br />
Additional case-control analysis (see Appendices C, D and E) sho<strong>we</strong>d an association with fetal congenital<br />
anomaly but not with fetal or neonatal death from 20 <strong>we</strong>eks <strong>in</strong> babies without a congenital anomaly.<br />
43
Cl<strong>in</strong>ical c<strong>are</strong> issues: preconception<br />
8.5.1 Panel comments on suboptimal preconception c<strong>are</strong><br />
Enquiry panels made 349 comments about preconception c<strong>are</strong>. There <strong>we</strong>re approximately equal numbers<br />
of comments about cl<strong>in</strong>ical c<strong>are</strong> issues and social and lifestyle issues. The social and lifestyle issues<br />
identifi ed <strong>we</strong>re identical to those described <strong>in</strong> Chapter 7, and <strong>are</strong> not reported aga<strong>in</strong> here. With respect<br />
to cl<strong>in</strong>ical c<strong>are</strong> issues, health professionals did not take <strong>the</strong> opportunity to give preconception advice,<br />
<strong>in</strong>clud<strong>in</strong>g advice about contraception and folic acid, for 43% of women with suboptimal preconception c<strong>are</strong><br />
(table 8.2). There <strong>we</strong>re concerns about screen<strong>in</strong>g and management of diabetes complications for nearly a<br />
tenth of <strong>the</strong> women.<br />
Table 8.2<br />
Panel comments on suboptimal preconception c<strong>are</strong> <strong>in</strong> women with pre-exist<strong>in</strong>g diabetes (table conta<strong>in</strong>s <strong>in</strong>formation<br />
follow<strong>in</strong>g categorisation of free text)<br />
Women assessed to have suboptimal preconception c<strong>are</strong><br />
Good <strong>pregnancy</strong> outcome<br />
(N=80)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Poor <strong>pregnancy</strong> outcome<br />
(N=116)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Total comments* 51 88<br />
Suboptimal cl<strong>in</strong>ical practice 47 - 74 -<br />
Folic acid not advised or prescribed 16 20 21 18<br />
Did not take opportunity to give<br />
preconception advice 12 15 20 17<br />
Poor screen<strong>in</strong>g or management<br />
of diabetes complications 8 10 9 8<br />
Contraception not advised 6 8 10 9<br />
Suboptimal review of medication 1 1 8 7<br />
O<strong>the</strong>r 4 5 7 6<br />
Communication bet<strong>we</strong>en health<br />
professionals or bet<strong>we</strong>en health service<br />
2 3 9 8<br />
and woman<br />
Miscellaneous 2 3 5 4<br />
* There <strong>we</strong>re 70 comments where <strong>the</strong> woman did not receive folic acid and 3 comments where she did not have preconception<br />
c<strong>are</strong>, where it was unclear as to whe<strong>the</strong>r this was a cl<strong>in</strong>ical c<strong>are</strong> or social and lifestyle issue; <strong>the</strong>se comments <strong>are</strong> not <strong>in</strong>cluded <strong>in</strong> <strong>the</strong><br />
table. There <strong>we</strong>re 137 comments on social and lifestyle issues, ho<strong>we</strong>ver <strong>the</strong>se <strong>we</strong>re identical to <strong>the</strong> <strong>the</strong>mes underly<strong>in</strong>g suboptimal<br />
preconception glycaemic control (Chapter 7) and <strong>are</strong> not described fur<strong>the</strong>r <strong>in</strong> this report.<br />
8.6 Glycaemic control tests and targets<br />
Regular test<strong>in</strong>g of long term glycaemic control us<strong>in</strong>g glycosylated haemoglob<strong>in</strong> (HbA1c) is important <strong>in</strong><br />
order to <strong>in</strong>form <strong>the</strong> management of glycaemic control (<strong>Diabetes</strong> NSF 2001). 1 Targets for glycaemic control<br />
should be set and discussed with women before <strong>pregnancy</strong>, so that <strong>the</strong>y can take control of manag<strong>in</strong>g <strong>the</strong>ir<br />
diabetes more effectively.<br />
44
8.6.1 Enquiry fi nd<strong>in</strong>gs<br />
Just over half (58%, 218/379) of women <strong>in</strong> <strong>the</strong> enquiry (54% of 192 cases and 62% of 187 controls)<br />
<strong>we</strong>re reported to have had a test of glycaemic control <strong>in</strong> <strong>the</strong> 12 months before <strong>pregnancy</strong>. This comp<strong>are</strong>s<br />
favourably with <strong>the</strong> 37% reported for <strong>the</strong> full cohort of 3808 diabetic pregnancies. 2 This may be because<br />
<strong>the</strong> enquiry data related to 12 months before conception ra<strong>the</strong>r than just 6 months as for <strong>the</strong> full cohort,<br />
and may also be due to <strong>the</strong> fact that <strong>in</strong>formation for <strong>the</strong> full cohort was dependent upon medical records at<br />
secondary c<strong>are</strong>, while <strong>in</strong> <strong>the</strong> enquiry module <strong>the</strong> general practitioner and adult diabetes service <strong>we</strong>re also<br />
approached for <strong>in</strong>formation.<br />
Sixteen percent of 379 women did not have a glycaemic control test <strong>in</strong> <strong>the</strong> year before <strong>pregnancy</strong>, and for<br />
more than a quarter (27%, 101/379) of women <strong>the</strong>re was no documentation available.<br />
There was evidence that targets for glycaemic control had been set before <strong>pregnancy</strong> for only 28% of 369<br />
women (24% of 188 cases and 32% of 181 controls); for 52% of women, <strong>the</strong>re was no documentation <strong>in</strong><br />
<strong>the</strong> medical records (ei<strong>the</strong>r at primary or secondary c<strong>are</strong>) about targets.<br />
8.7 Panel assessment of glycaemic control before <strong>pregnancy</strong><br />
The enquiry panels assessed that 79% of 354 women with available documentation (88% of 187 cases<br />
and 69% of 167 controls) had suboptimal glycaemic control before <strong>pregnancy</strong>. Women who had suboptimal<br />
preconception glycaemic control <strong>we</strong>re more likely to go on to have a poor <strong>pregnancy</strong> outcome (OR 3.89,<br />
95% CI 2.15 - 7.02, adjusted for maternal age and deprivation, see Chapter 6).<br />
8.7.1 Panel comments on suboptimal preconception glycaemic control<br />
The majority of enquiry panel comments related to social and lifestyle issues, and <strong>the</strong>se <strong>are</strong> described <strong>in</strong><br />
Chapter 7. Ho<strong>we</strong>ver, <strong>the</strong>re <strong>we</strong>re 48 comments about cl<strong>in</strong>ical c<strong>are</strong> (table 8.3). The ma<strong>in</strong> concerns about<br />
cl<strong>in</strong>ical practice <strong>we</strong>re a lack of timely cl<strong>in</strong>ical <strong>in</strong>put by health professionals to improve glycaemic control,<br />
and also concerns that <strong>the</strong> <strong>in</strong>sul<strong>in</strong> regime advised was <strong>in</strong>adequate to achieve tighter control. Suboptimal<br />
communication referred ma<strong>in</strong>ly to poor follow-up of non-attenders and women who had lost contact with<br />
<strong>the</strong> health service.<br />
45
Cl<strong>in</strong>ical c<strong>are</strong> issues: preconception<br />
Table 8.3<br />
Panel comments about cl<strong>in</strong>ical c<strong>are</strong> issues related to suboptimal preconception glycaemic control (table conta<strong>in</strong>s<br />
<strong>in</strong>formation follow<strong>in</strong>g categorisation of free text)<br />
Women assessed to have suboptimal<br />
preconception glycaemic control<br />
Good <strong>pregnancy</strong> outcome<br />
(N=115)<br />
Poor <strong>pregnancy</strong> outcome<br />
(N=165)<br />
No. of comments % of women No. of comments % of women<br />
Total comments* † 20 28<br />
Suboptimal cl<strong>in</strong>ical practice 15 13 11 7<br />
Suboptimal communication 5 4 16 10<br />
Miscellaneous 0 0 1 1<br />
* There <strong>we</strong>re 81 comments where <strong>the</strong> issues <strong>we</strong>re not described by panels and 18 comments where <strong>the</strong>re was a lack of<br />
preconception c<strong>are</strong> with <strong>the</strong> reason be<strong>in</strong>g unclear to panels; <strong>the</strong>se comments <strong>are</strong> not <strong>in</strong>cluded <strong>in</strong> this table.<br />
† 187 comments <strong>we</strong>re made on social and lifestyle issues; <strong>the</strong>se <strong>are</strong> described <strong>in</strong> Chapter 7.<br />
8.8 Conclusions<br />
Prior to <strong>pregnancy</strong>, cl<strong>in</strong>ical support and <strong>in</strong>formation for women appe<strong>are</strong>d to be poor:<br />
• Just over half of women had a ret<strong>in</strong>al exam<strong>in</strong>ation and a renal function test <strong>in</strong> <strong>the</strong> 12 months before<br />
<strong>pregnancy</strong>.<br />
• Only a quarter of women had evidence of glycaemic control targets be<strong>in</strong>g set and just over half<br />
had documented evidence of a discussion about glycaemic control <strong>in</strong> <strong>the</strong> 12 months prior to<br />
<strong>pregnancy</strong>.<br />
• Less than half of women had documented evidence that diet, contraception, or diabetes<br />
complications had been discussed <strong>in</strong> <strong>the</strong> 12 months before <strong>pregnancy</strong>.<br />
• Less than half of women <strong>we</strong>re documented to be <strong>in</strong>formed about fetal risks, <strong>the</strong> <strong>in</strong>creased chance<br />
of <strong>in</strong>duction of labour and <strong>the</strong> possibility of caes<strong>are</strong>an delivery.<br />
• Documentation of pre-<strong>pregnancy</strong> counsell<strong>in</strong>g was poor.<br />
Enquiry panels found that health professionals often missed <strong>the</strong> opportunity to provide pre-<strong>pregnancy</strong><br />
counsell<strong>in</strong>g, and did not appear to advise about or prescribe folic acid or contraception before <strong>pregnancy</strong>.<br />
There <strong>we</strong>re also concerns about a lack of timely <strong>in</strong>put by <strong>the</strong> diabetes team and whe<strong>the</strong>r <strong>in</strong>sul<strong>in</strong> regimes <strong>in</strong><br />
<strong>the</strong> preconception period <strong>we</strong>re appropriate to achieve tight glycaemic control.<br />
These fi nd<strong>in</strong>gs suggest that <strong>the</strong> majority of women with diabetes <strong>are</strong> not hav<strong>in</strong>g effective annual diabetes<br />
reviews, and that <strong>the</strong> maternity component of preconception c<strong>are</strong> (contraception, folic acid, <strong>in</strong>formation<br />
about <strong>the</strong> impact of diabetes on <strong>pregnancy</strong>) is miss<strong>in</strong>g for many women.<br />
46
Some quotes from <strong>the</strong> panel discussions<br />
Preconception c<strong>are</strong>:<br />
• 'No folic acid prescribed or started, even though <strong>the</strong> <strong>pregnancy</strong> was planned and <strong>the</strong> woman was<br />
hav<strong>in</strong>g treatment to aid fertility.'<br />
• 'Only one pre-<strong>pregnancy</strong> appo<strong>in</strong>tment, no folate, no smok<strong>in</strong>g advice, or advice about<br />
contraception' .<br />
• 'No ret<strong>in</strong>al screen<strong>in</strong>g. Planned <strong>pregnancy</strong> no adequate monitor<strong>in</strong>g. Inadequate c<strong>are</strong> by GP and<br />
primary c<strong>are</strong>. Low dose folic acid.'<br />
• 'Despite 16 visits no evidence of <strong>in</strong>put from a consultant physician.'<br />
• 'No ret<strong>in</strong>al checks or discussion of diabetes control.'<br />
• 'Evidence of ret<strong>in</strong>opathy & microalbum<strong>in</strong>uria present but not given an appo<strong>in</strong>tment for one year.<br />
Woman's attendance and compliance was poor, but no documentation of a defi nite plan. ACE<br />
<strong>in</strong>hibitor prescribed. Not a planned <strong>pregnancy</strong> - folic acid not given.'<br />
• 'No folic acid. Type 2 diabetes on metform<strong>in</strong>. ACE <strong>in</strong>hibitor (Per<strong>in</strong>dopril) not stopped. BMI 52. No<br />
recorded thyroid function test, on thyrox<strong>in</strong>e for hypothyroidism 1 year.'<br />
Glycaemic control:<br />
• 'HbA1c>8 Panel felt: Health c<strong>are</strong> professionals could have done more to help patient to reduce<br />
HbA1c. Panel felt that this woman may have needed <strong>in</strong>sul<strong>in</strong>. Patient did no follow diet.'<br />
• 'HBA1c 10.2. Sought pre-<strong>pregnancy</strong> advice. Documented advice by consultant physician to GP to<br />
change <strong>in</strong>sul<strong>in</strong>, this was not acted upon.'<br />
• 'Pre-<strong>pregnancy</strong> HbA1c was 14.4% but mo<strong>the</strong>r not revie<strong>we</strong>d for 6 <strong>we</strong>eks, HbA1c <strong>the</strong>n 13.8%.<br />
Inappropriate small doses of <strong>in</strong>sul<strong>in</strong>'<br />
• 'HBA1c 7.7%. Twice daily <strong>in</strong>sul<strong>in</strong> regime that was not adequate. No evidence of pre-<strong>pregnancy</strong><br />
plann<strong>in</strong>g. Physician quotes that control good, this may have misled woman re <strong>pregnancy</strong> risks.<br />
Overcautious to avoid hypos'<br />
8.9 Recommendations<br />
Cl<strong>in</strong>ical<br />
1. Commissioners of services must ensure that all women with diabetes <strong>are</strong> provided with specialist<br />
preconception services, with access to all members of <strong>the</strong> specialist multidiscipl<strong>in</strong>ary team. As a<br />
m<strong>in</strong>imum, <strong>the</strong>se services should <strong>in</strong>clude:<br />
• Clear signpost<strong>in</strong>g to different aspects of c<strong>are</strong><br />
• Diet and lifestyle advice<br />
• Provision of appropriate contraception<br />
• Higher dose folic acid supplementation<br />
• Smok<strong>in</strong>g cessation support<br />
• Assessment and management of diabetes complications<br />
47
Cl<strong>in</strong>ical c<strong>are</strong> issues: preconception<br />
• Sett<strong>in</strong>g of glycaemic control targets and regular discussion of results of self-monitor<strong>in</strong>g, to enable<br />
<strong>the</strong> woman to achieve control that is as near to normal as possible before conception<br />
• Discussion of diabetes <strong>pregnancy</strong> risks and expected management strategies<br />
• Clear documentation of c<strong>are</strong> and counsell<strong>in</strong>g, ideally us<strong>in</strong>g a standard template.<br />
Audit and research<br />
2. Preconception services should be audited to ensure that m<strong>in</strong>imum standards <strong>are</strong> be<strong>in</strong>g met.<br />
References<br />
1. National Service Framework for <strong>Diabetes</strong> (England) Standards. Department of Health.<br />
The Stationery Offi ce: London: 2001.<br />
2. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Pregnancy <strong>in</strong> women with type 1 and<br />
type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
3. Mac<strong>in</strong>tosh M, Flem<strong>in</strong>g K, Bailey J, Doyle P, Modder J, Acolet D, et al. Per<strong>in</strong>atal mortality and<br />
congenital anomalies <strong>in</strong> babies of women with type 1 or type 2 diabetes <strong>in</strong> England, Wales and<br />
Nor<strong>the</strong>rn Ireland: population based study. BMJ, 22 Jul 2006: 333 (7560):177.<br />
4. Pregnancy outcomes <strong>in</strong> <strong>the</strong> <strong>Diabetes</strong> Complications Trial. The <strong>Diabetes</strong> Control and Complications<br />
Trial Research Group. Am J Obstet Gynecol; 1996; 174: 1343-53.<br />
5. Lumley J, Watson L, Watson M, Bo<strong>we</strong>r C. Cochrane Pregnancy and Childbirth Group.<br />
Periconceptional supplementation with folate and/or multivitam<strong>in</strong>s for prevent<strong>in</strong>g neural tube defects.<br />
Cochrane Database of Systematic Reviews. 2006, 3.<br />
6. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Survey of maternity services for women with<br />
type 1 and type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London;<br />
2005.<br />
Commentary<br />
Sue Roberts<br />
National Cl<strong>in</strong>ical Director for <strong>Diabetes</strong><br />
Consultant <strong>Diabetes</strong> Physician, North Tyneside General Hospital<br />
This chapter pa<strong>in</strong>ts a disturb<strong>in</strong>g picture of a lack of diabetes preconception c<strong>are</strong> services across England,<br />
Wales and Nor<strong>the</strong>rn Ireland, and a lack of knowledge both on <strong>the</strong> part of healthc<strong>are</strong> professionals<br />
and women with diabetes, about <strong>the</strong> importance of preconception c<strong>are</strong>. The evidence <strong>in</strong>dicates that<br />
preconception c<strong>are</strong> is vital <strong>in</strong> try<strong>in</strong>g to ensure that both mo<strong>the</strong>rs and babies have as safe and healthy<br />
a <strong>pregnancy</strong> and birth as possible. The fi nd<strong>in</strong>gs <strong>in</strong> this report suggest that when <strong>the</strong>re is suboptimal<br />
preconception c<strong>are</strong>, <strong>pregnancy</strong> outcomes can be devastat<strong>in</strong>g for <strong>the</strong> mo<strong>the</strong>r-to-be and her baby.<br />
Adult diabetes services and primary c<strong>are</strong> professionals <strong>are</strong> often <strong>in</strong> contact with women prior to <strong>pregnancy</strong>,<br />
and <strong>the</strong>refore have a real responsibility to provide relevant <strong>in</strong>formation and monitor<strong>in</strong>g, both <strong>in</strong> <strong>the</strong><br />
immediate pre-<strong>pregnancy</strong> period and as part of women’s rout<strong>in</strong>e c<strong>are</strong>. In <strong>the</strong> current situation, many<br />
women <strong>are</strong> miss<strong>in</strong>g out on <strong>in</strong>formation and monitor<strong>in</strong>g as part of <strong>the</strong>ir rout<strong>in</strong>e c<strong>are</strong> on a year by year basis.<br />
48
Apart from <strong>the</strong> explanation of <strong>pregnancy</strong> risks and <strong>the</strong> need to ma<strong>in</strong>ta<strong>in</strong> good glycaemic control, some<br />
drugs which may be prescribed for women with type 2 diabetes, such as ACE <strong>in</strong>hibitors, <strong>are</strong> harmful <strong>in</strong><br />
<strong>pregnancy</strong>. This emphasis on <strong>in</strong>form<strong>in</strong>g women of <strong>the</strong> risks and <strong>the</strong> preventive actions <strong>the</strong>y can take,<br />
means that diabetes services for women of child bear<strong>in</strong>g age should be planned <strong>in</strong> a slightly different way<br />
to o<strong>the</strong>r diabetes services. This is supported by <strong>the</strong> recently developed diabetes workforce competencies c<br />
that specifi cally address <strong>the</strong> needs of women of child bear<strong>in</strong>g age with diabetes, as <strong>we</strong>ll as those actively<br />
seek<strong>in</strong>g to become pregnant, and those who <strong>are</strong> already pregnant.<br />
The current absence of structured preconception c<strong>are</strong> needs to be set with<strong>in</strong> <strong>the</strong> context of <strong>the</strong> <strong>in</strong>creas<strong>in</strong>g<br />
number of women of child bear<strong>in</strong>g age with diabetes – ma<strong>in</strong>ly type 2 diabetes. This rise has been fuelled<br />
by a number of factors, <strong>in</strong>clud<strong>in</strong>g <strong>the</strong> <strong>in</strong>creas<strong>in</strong>g obesity of <strong>the</strong> general population, chang<strong>in</strong>g ethnic<br />
demographics and reduc<strong>in</strong>g levels of exercise and fi tness. An additional factor is that women from ethnic<br />
m<strong>in</strong>ority groups with an <strong>in</strong>creased risk of type 2 diabetes, tend to have larger families. The General<br />
Household Survey 1988-2001 d found that women of Bangladeshi orig<strong>in</strong> tended on average to have<br />
families twice as large as <strong>the</strong> White population.<br />
The <strong>Diabetes</strong> National Service Framework (NSF) recommends that all diabetes services should be<br />
effectively planned, but it is clear that this is currently not <strong>the</strong> case for <strong>the</strong> majority of local services across<br />
<strong>the</strong> country, ei<strong>the</strong>r for rout<strong>in</strong>e or preconception c<strong>are</strong>. While <strong>pregnancy</strong> <strong>in</strong> women with diabetes used to be<br />
considered a specialist activity, <strong>the</strong>re is now a critical need for services to be planned jo<strong>in</strong>tly <strong>in</strong> primary<br />
as <strong>we</strong>ll as secondary c<strong>are</strong> <strong>in</strong> order to achieve <strong>in</strong>tegrated models of preconception and <strong>pregnancy</strong> c<strong>are</strong>.<br />
This is an immense challenge, and diabetes networks have a crucial role <strong>in</strong> support<strong>in</strong>g this plann<strong>in</strong>g and<br />
commission<strong>in</strong>g process by enabl<strong>in</strong>g each of <strong>the</strong> stakeholders to identify needs and priorities.<br />
Although it may be diffi cult to accept, <strong>we</strong> must understand that <strong>pregnancy</strong> for women with diabetes will<br />
always be high risk. Ho<strong>we</strong>ver, it is our responsibility to discover new ways of work<strong>in</strong>g with women that<br />
will reduce <strong>the</strong> risks and ensure <strong>the</strong> <strong>best</strong> possible outcomes, both for <strong>the</strong>m and <strong>the</strong>ir babies.<br />
c<br />
Skills for Health, <strong>Diabetes</strong> Workforce Competencies, 2006.<br />
d<br />
Sources: Census 2001, Offi ce for National Statistics; General Register Offi ce for Scotland.<br />
49
9. Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong><br />
Learn<strong>in</strong>g po<strong>in</strong>ts<br />
• Suboptimal glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong> was associated with poor <strong>pregnancy</strong> outcome.<br />
The ma<strong>in</strong> cl<strong>in</strong>ical issues identifi ed <strong>we</strong>re failure to change <strong>in</strong>sul<strong>in</strong> regimes to achieve good<br />
glycaemic control, and a non-responsive local strategy of diabetes antenatal c<strong>are</strong>.<br />
• Suboptimal maternity c<strong>are</strong> and diabetes c<strong>are</strong> (exclud<strong>in</strong>g glycaemic control) dur<strong>in</strong>g <strong>pregnancy</strong><br />
was associated with poor <strong>pregnancy</strong> outcome. Underly<strong>in</strong>g issues <strong>in</strong>cluded suboptimal fetal and<br />
maternal surveillance and suboptimal monitor<strong>in</strong>g of diabetes complications.<br />
• For babies with antenatal evidence of macrosomia, suboptimal antenatal fetal surveillance was<br />
associated with poor <strong>pregnancy</strong> outcome, with <strong>the</strong> ma<strong>in</strong> issues be<strong>in</strong>g lack of timely follow up and<br />
poor <strong>in</strong>terpretation of ultrasound scans.<br />
• Women who had a poor <strong>pregnancy</strong> outcome <strong>we</strong>re more likely not to receive postnatal<br />
contraceptive advice and more likely to have suboptimal postnatal diabetes c<strong>are</strong>.<br />
9.1 Introduction<br />
Dur<strong>in</strong>g <strong>pregnancy</strong>, <strong>the</strong>re <strong>are</strong> often rapid changes <strong>in</strong> glycaemic control due to <strong>in</strong>creas<strong>in</strong>g <strong>in</strong>sul<strong>in</strong> resistance.<br />
Suboptimal glycaemic control has been associated with fetal congenital anomaly, 1 an <strong>in</strong>creased risk of<br />
miscarriage 2 and fetal macrosomia; 3 and <strong>the</strong>re may also be placental <strong>in</strong>sufficiency (particularly associated<br />
with nephropathy) result<strong>in</strong>g <strong>in</strong> fetal growth restriction. Women <strong>the</strong>mselves may have complications<br />
<strong>in</strong>clud<strong>in</strong>g hypoglycaemia, ret<strong>in</strong>opathy, nephropathy, diabetic ketoacidosis and pre-eclampsia. Cl<strong>in</strong>icians and<br />
health services have an important role <strong>in</strong> build<strong>in</strong>g relationships with women before and dur<strong>in</strong>g <strong>pregnancy</strong>,<br />
empo<strong>we</strong>r<strong>in</strong>g <strong>the</strong>m to manage <strong>the</strong>ir diabetes, and provid<strong>in</strong>g effective maternal and fetal surveillance.<br />
9.2 Glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong>, labour and delivery<br />
Tight glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong> is one of <strong>the</strong> ma<strong>in</strong> pr<strong>in</strong>ciples of management for women with<br />
pre-exist<strong>in</strong>g diabetes. Dur<strong>in</strong>g labour and delivery, good glycaemic control should be ma<strong>in</strong>ta<strong>in</strong>ed to reduce<br />
<strong>the</strong> risk of neonatal hypoglycaemia. 4<br />
The 2005 CEMACH report 5 on pregnant women with pre-exist<strong>in</strong>g diabetes found that although<br />
approximately three quarters of 2732 women had a glycosylated haemoglob<strong>in</strong> test (HbA1c) performed<br />
dur<strong>in</strong>g <strong>the</strong> fi rst trimester of <strong>pregnancy</strong>, just over a third of <strong>the</strong>se women achieved an HbA1c value less<br />
than 7%. This improved <strong>in</strong> <strong>the</strong> second and third trimesters, with two thirds of women with an HbA1c test<br />
achiev<strong>in</strong>g a result less than 7%.<br />
9.2.1 Enquiry fi nd<strong>in</strong>gs<br />
Enquiry panels assessed that <strong>the</strong> majority of women <strong>in</strong> <strong>the</strong> enquiry had suboptimal glycaemic control<br />
dur<strong>in</strong>g <strong>pregnancy</strong> (84% of 204 cases and 61% of 192 controls <strong>in</strong> <strong>the</strong> fi rst trimester; 71% of 205 cases and<br />
37% of 209 controls after <strong>the</strong> fi rst trimester). Suboptimal glycaemic control at any time dur<strong>in</strong>g <strong>pregnancy</strong><br />
50
was associated with poor <strong>pregnancy</strong> outcome (OR 3.4, 95% CI 2.1 - 5.7 <strong>in</strong> fi rst trimester and OR 5.2,<br />
95% CI 3.3 - 8.2 after fi rst trimester, both ORs adjusted for maternal age and deprivation, see Chapter 6).<br />
Fifty percent (176/354) of women (49% of 162 cases, 48% of 202 controls) with ongo<strong>in</strong>g pregnancies after<br />
24 <strong>we</strong>eks <strong>we</strong>re assessed by panels to have suboptimal glycaemic control dur<strong>in</strong>g labour and/or delivery.<br />
9.2.2 Panel comments on suboptimal glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong><br />
The majority of panel comments related to social and lifestyle issues and <strong>the</strong>se <strong>are</strong> described <strong>in</strong> Chapter<br />
7. Ho<strong>we</strong>ver, <strong>the</strong>re <strong>we</strong>re 178 panel comments made on cl<strong>in</strong>ical c<strong>are</strong> issues, with <strong>the</strong> ma<strong>in</strong> concern be<strong>in</strong>g<br />
suboptimal cl<strong>in</strong>ical practice (table 9.1). This <strong>in</strong>cluded failure to change <strong>in</strong>sul<strong>in</strong> regimes to achieve good<br />
glycaemic control, and a non-responsive local strategy of diabetes antenatal c<strong>are</strong>, <strong>in</strong>clud<strong>in</strong>g lack of<br />
support, failure to follow up women, and poor <strong>in</strong>tegration of <strong>the</strong> c<strong>are</strong> provided by different discipl<strong>in</strong>es.<br />
Problems with<strong>in</strong> <strong>the</strong> diabetes multidiscipl<strong>in</strong>ary team <strong>in</strong>cluded lack of <strong>in</strong>volvement of consultant obstetricians<br />
or diabetes physicians, and lack of dietetic <strong>in</strong>put.<br />
Table 9.1<br />
Panel comments on suboptimal glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong> <strong>in</strong> women with type 1 and type 2 diabetes<br />
(table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation of free text)<br />
Women assessed to have suboptimal<br />
glycaemic control <strong>in</strong> 1st trimester<br />
Good <strong>pregnancy</strong><br />
outcome<br />
(N=118)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Poor <strong>pregnancy</strong><br />
outcome<br />
(N=171)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Women assessed to have suboptimal<br />
glycaemic control after 1st trimester<br />
Good <strong>pregnancy</strong><br />
outcome<br />
(N=76)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Poor <strong>pregnancy</strong><br />
outcome<br />
(N=146)<br />
No. of<br />
comments<br />
% of<br />
women<br />
Total comments* 34 - 46 35 - 63<br />
Suboptimal cl<strong>in</strong>ical<br />
practice 30 - 32 - 27 - 47 -<br />
Failure to change<br />
<strong>in</strong>sul<strong>in</strong> regime 13 11 9 5 11 14 18 12<br />
Non-responsive local<br />
strategy of diabetes 7 6 9 5 9 12 15 10<br />
antenatal c<strong>are</strong><br />
Problems<br />
with<strong>in</strong> diabetes<br />
multidiscipl<strong>in</strong>ary<br />
team<br />
8 7 4 2 6 8 10 7<br />
Lack of<br />
preconception c<strong>are</strong> 2 2 5 3 0 - 2 1<br />
Inappropriate<br />
management (o<strong>the</strong>r 0 - 4 2 1 1 2 1<br />
than <strong>in</strong>sul<strong>in</strong>)<br />
Did not follow<br />
guidel<strong>in</strong>e 0 - 1 1 0 - 0 -<br />
Poor<br />
documentation /<br />
communication<br />
4 3 14 8 8 11 16 11<br />
* 248 comments <strong>we</strong>re made on social and lifestyle issues. In 198 comments, panels did not describe <strong>the</strong> specifi c issue underly<strong>in</strong>g<br />
suboptimal glycaemic control.<br />
51
Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong><br />
9.2.3 Panel comments on suboptimal glycaemic control dur<strong>in</strong>g labour and delivery<br />
The guidance given to enquiry panels was that optimal glycaemic control dur<strong>in</strong>g labour and delivery<br />
referred to blood glucose values bet<strong>we</strong>en 3.5 – 8 mmols/l, although this was not prescriptive. The target<br />
range recommended by <strong>Diabetes</strong> UK for labour and delivery is 4– 6 mmol/l 6 and <strong>the</strong> <strong>Diabetes</strong> NSF<br />
recommends tight blood glucose control dur<strong>in</strong>g labour. 7<br />
Panels made 211 comments for 176 women about suboptimal glycaemic control dur<strong>in</strong>g labour and<br />
delivery. The ma<strong>in</strong> issue identifi ed was suboptimal cl<strong>in</strong>ical practice, particularly concerns about <strong>in</strong>adequate<br />
<strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong>/dextrose regimes, delays <strong>in</strong> commenc<strong>in</strong>g <strong>in</strong>travenous regimes and <strong>the</strong> subsequent<br />
management of those regimes (table 9.2).<br />
Table 9.2<br />
Panel comments on suboptimal glycaemic control dur<strong>in</strong>g labour and delivery (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g<br />
categorisation of free text)<br />
Women assessed to have suboptimal glycaemic control dur<strong>in</strong>g<br />
labour and delivery<br />
Good <strong>pregnancy</strong> outcome<br />
n=96<br />
Poor <strong>pregnancy</strong> outcome<br />
n=80<br />
No. of comments % of women No. of comments % of women<br />
Total comments* 98 - 70 -<br />
Suboptimal cl<strong>in</strong>ical practice 90 - 62 -<br />
Inappropriate <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong>/<br />
dextrose regime 26 27 8 11<br />
Delay <strong>in</strong> start<strong>in</strong>g <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong>/<br />
dextrose regime 19 19 14 20<br />
Poor management of slid<strong>in</strong>g scale 17 17 17 24<br />
Suboptimal blood glucose monitor<strong>in</strong>g 15 15 10 14<br />
Hypoglycaemia due to cl<strong>in</strong>ical practice 2 2 4 6<br />
Poor management of hypoglycaemia 4 4 2 3<br />
O<strong>the</strong>r cl<strong>in</strong>ical practice issues 7 7 7 10<br />
Communication issues 4 4 6 9<br />
Resource issues 2 2 0 0<br />
Patient issues 2 2 2 3<br />
* The underly<strong>in</strong>g issues <strong>we</strong>re not described <strong>in</strong> 43 comments made by panels.<br />
9.3 Glycaemic control targets<br />
It is important that women should be <strong>in</strong>formed of what short and long term glycaemic control targets <strong>the</strong>y<br />
<strong>are</strong> try<strong>in</strong>g to achieve, to enable <strong>the</strong>m to optimise <strong>the</strong>ir control.<br />
9.3.1 Enquiry fi nd<strong>in</strong>gs<br />
Target ranges for glycaemic control <strong>we</strong>re documented <strong>in</strong> <strong>the</strong> medical records or local hospital guidel<strong>in</strong>es for<br />
just over half of women dur<strong>in</strong>g <strong>pregnancy</strong> (53%, 232/440 of women <strong>in</strong> <strong>the</strong> fi rst trimester and 54%, 239/441<br />
52
of women after <strong>the</strong> fi rst trimester up to labour and delivery). This improved dur<strong>in</strong>g labour and delivery,<br />
with 79% of <strong>the</strong> 384 women deliver<strong>in</strong>g after 24 <strong>we</strong>eks hav<strong>in</strong>g a target range documented.<br />
When a target range was present dur<strong>in</strong>g <strong>pregnancy</strong>, <strong>the</strong>re was evidence that this had been communicated<br />
to <strong>the</strong> woman for only 48% of <strong>the</strong> 232 women <strong>in</strong> <strong>the</strong> fi rst trimester and 51% of <strong>the</strong> 239 women after <strong>the</strong><br />
fi rst trimester.<br />
9.4 <strong>Diabetes</strong> c<strong>are</strong> - monitor<strong>in</strong>g for diabetes complications<br />
In addition to achiev<strong>in</strong>g good glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong>, women with diabetes also need ongo<strong>in</strong>g<br />
monitor<strong>in</strong>g and treatment for diabetes complications. There may be development of new ret<strong>in</strong>opathy<br />
or deterioration of pre-exist<strong>in</strong>g ret<strong>in</strong>opathy dur<strong>in</strong>g <strong>pregnancy</strong>, 8 and women should have a full ret<strong>in</strong>al<br />
assessment dur<strong>in</strong>g <strong>the</strong> fi rst trimester, 7 with prompt referral to an ophthalmologist if an abnormality is found.<br />
Women with diabetes nephropathy <strong>are</strong> at <strong>in</strong>creased risk of hypertensive disease of <strong>pregnancy</strong>, adverse<br />
fetal outcomes, and progressive deterioration of renal disease. 9-11 Enquiry panels <strong>we</strong>re not provided with<br />
an explicit standard of monitor<strong>in</strong>g for nephropathy, but <strong>we</strong>re provided with <strong>the</strong> guidance that appropriate<br />
monitor<strong>in</strong>g <strong>in</strong>cluded test<strong>in</strong>g for microalbum<strong>in</strong>uria (<strong>in</strong>cipient nephropathy), prote<strong>in</strong> dipstick test<strong>in</strong>g of ur<strong>in</strong>e<br />
or serum creat<strong>in</strong><strong>in</strong>e.<br />
9.4.1 Enquiry fi nd<strong>in</strong>gs<br />
Just over half of women (59%, 258/441), had a ret<strong>in</strong>al assessment documented dur<strong>in</strong>g <strong>the</strong> fi rst trimester<br />
or at <strong>the</strong> fi rst book<strong>in</strong>g visit. Only 55% of <strong>the</strong>se 258 assessments <strong>we</strong>re recorded to have been done through<br />
dilated pupils; for 40% of women, details about <strong>the</strong> ret<strong>in</strong>al assessment procedure <strong>we</strong>re not documented.<br />
Seventy eight percent (343/441) of women <strong>we</strong>re monitored for signs of nephropathy. Lack of monitor<strong>in</strong>g<br />
for nephropathy was associated with poor <strong>pregnancy</strong> outcome (OR 1.9, 95% CI 1.1 - 3.3, adjusted for<br />
maternal age and deprivation, see Chapter 6). Ho<strong>we</strong>ver, <strong>in</strong> <strong>the</strong> additional case-control analysis (see<br />
Appendices C, D and E), lack of monitor<strong>in</strong>g for nephropathy was associated only with fetal congenital<br />
anomaly and not with fetal or neonatal death after 20 <strong>we</strong>eks gestation, and is <strong>the</strong>refore unlikely to have<br />
been causative for poor <strong>pregnancy</strong> outcome. Nephropathy itself was not associated with poor <strong>pregnancy</strong><br />
outcome.<br />
Enquiry panels assessed that 60% (264/440) of women (72% of 204 cases and 58% of 204 controls)<br />
had suboptimal diabetes c<strong>are</strong> (c<strong>are</strong> o<strong>the</strong>r than glycaemic control management) dur<strong>in</strong>g <strong>pregnancy</strong>. These<br />
women <strong>we</strong>re more likely to have a poor <strong>pregnancy</strong> outcome (OR 1.7, 95% CI 1.1 - 2.6, adjusted for<br />
maternal age and deprivation, see Chapter 6). Additional case-control analysis (see Appendices C, D<br />
and E) sho<strong>we</strong>d an association with fetal or neonatal death from 20 <strong>we</strong>eks gestation and not with fetal<br />
congenital anomaly.<br />
9.4.2 Panel comments on suboptimal diabetes c<strong>are</strong> <strong>in</strong> <strong>pregnancy</strong><br />
Panels made 432 comments for 264 women about suboptimal diabetes c<strong>are</strong> <strong>in</strong> <strong>pregnancy</strong>, with <strong>the</strong><br />
majority of <strong>the</strong>se be<strong>in</strong>g concerns about suboptimal cl<strong>in</strong>ical practice (table 9.3).<br />
53
Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong><br />
Table 9.3<br />
Panel comments on suboptimal diabetes c<strong>are</strong> (exclud<strong>in</strong>g glycaemic control) <strong>in</strong> <strong>pregnancy</strong> (table conta<strong>in</strong>s <strong>in</strong>formation<br />
follow<strong>in</strong>g categorisation of free text)<br />
Women assessed to have suboptimal diabetes c<strong>are</strong> <strong>in</strong> <strong>pregnancy</strong><br />
Good <strong>pregnancy</strong> outcome<br />
n=118<br />
Poor <strong>pregnancy</strong> outcome<br />
n=146<br />
No. of comments % of women No. of comments % of women<br />
Total comments* 174 - 224 -<br />
Suboptimal cl<strong>in</strong>ical practice 159 196<br />
Lack of /suboptimal ret<strong>in</strong>al screen<strong>in</strong>g/<br />
management 72 61 71 49<br />
Suboptimal renal function monitor<strong>in</strong>g/<br />
management 38 32 49 34<br />
Lack of multidiscipl<strong>in</strong>ary <strong>in</strong>volvement 25 21 31 21<br />
Lack of senior <strong>in</strong>put 2 2 7 5<br />
Poor management of glycaemic control<br />
dur<strong>in</strong>g steroid adm<strong>in</strong>istration 1 1 1 1<br />
Suboptimal management of<br />
pre-<strong>pregnancy</strong> medication 0 0 2 1<br />
Suboptimal management of o<strong>the</strong>r<br />
complications e.g. prote<strong>in</strong>uria +/-BP,<br />
6 5 12 8<br />
ketonuria<br />
Infrequent cl<strong>in</strong>ic appo<strong>in</strong>tments 2 2 9 6<br />
O<strong>the</strong>r 13 11 14 10<br />
Communication issues 5 4 9 6<br />
Patient factors 10 8 19 13<br />
* 34 comments <strong>we</strong>re about social and lifestyle issues.<br />
9.5 Antenatal fetal surveillance<br />
C<strong>are</strong>ful fetal surveillance is important <strong>in</strong> diabetic <strong>pregnancy</strong>, <strong>in</strong>clud<strong>in</strong>g serial ultrasound scans for fetal<br />
growth dur<strong>in</strong>g <strong>the</strong> third trimester and consideration of cardiotocograph monitor<strong>in</strong>g from 36 <strong>we</strong>eks. 7 Enquiry<br />
panels assessed that fetal surveillance was suboptimal for 20% of 37 babies with antenatal evidence of<br />
fetal growth restriction and for 45% of 129 babies with antenatal evidence of macrosomia (defi ned for<br />
panel enquiries as fetal size >90th centile). For babies with antenatal evidence of macrosomia, suboptimal<br />
fetal surveillance was associated with poor <strong>pregnancy</strong> outcome (OR 5.3, 95% CI 2.4 -12.0, adjusted for<br />
maternal age and deprivation, see Chapter 6). Additional case-control analysis (see Appendices C, D<br />
and E) sho<strong>we</strong>d an association with fetal or neonatal death after 20 <strong>we</strong>eks gestation and not with fetal<br />
congenital anomaly.<br />
54
9.5.1 Panel comments on suboptimal antenatal fetal surveillance<br />
Panels made 89 comments for 65 women about suboptimal antenatal fetal surveillance. The ma<strong>in</strong> issue for<br />
both macrosomic and growth restricted babies was a lack of timely follow-up (table 9.4). For macrosomic<br />
babies, <strong>the</strong>re <strong>we</strong>re also concerns about poor <strong>in</strong>terpretation of ultrasound scans and about actions taken as<br />
a response to tests.<br />
Table 9.4<br />
Panel comments on suboptimal antenatal fetal surveillance <strong>in</strong> women with pre-exist<strong>in</strong>g diabetes (table conta<strong>in</strong>s<br />
<strong>in</strong>formation follow<strong>in</strong>g categorisation of free text)<br />
Babies assessed to have suboptimal antenatal fetal surveillance<br />
Growth restricte<br />
babies<br />
(N=7)<br />
Macrosomic<br />
babies<br />
(N=58)<br />
No. of comments % of babies No. of comments % of babies<br />
Total comments* 8 - 74 -<br />
Suboptimal cl<strong>in</strong>ical practice 8 - 73 -<br />
Lack of timely follow-up 6 86 47 81<br />
Should have had additional<br />
<strong>in</strong>vestigations 0 - 2 3<br />
Poor <strong>in</strong>terpretation of surveillance 1 14 11 19<br />
Incorrect actions taken 1 14 11 19<br />
Poor standard of <strong>in</strong>vestigative<br />
procedure 0 - 2 3<br />
Poor communication 0 - 1 2<br />
* There <strong>we</strong>re 4 comments where <strong>the</strong> issues <strong>we</strong>re not described by panels, and 3 comments about social and lifestyle issues.<br />
9.6 Management of antenatal steroid adm<strong>in</strong>istration<br />
Women with pre-exist<strong>in</strong>g diabetes have a higher preterm delivery and spontaneous preterm labour rate<br />
comp<strong>are</strong>d to <strong>the</strong> general maternity population. 5 Women who <strong>are</strong> at risk of preterm delivery and require<br />
prophylactic antenatal steroids need c<strong>are</strong>ful management of glycaemic control to m<strong>in</strong>imise <strong>the</strong> risk of<br />
diabetic ketoacidosis, and it is recommended that additional <strong>in</strong>sul<strong>in</strong> should be given dur<strong>in</strong>g this time. 6,7<br />
9.6.1 Management of glycaemic control with antenatal steroids<br />
In <strong>the</strong> 2005 CEMACH study, 70% of women deliver<strong>in</strong>g a live born baby before 34 <strong>we</strong>eks received<br />
prophylactic steroids. 5<br />
In <strong>the</strong> enquiry, 56 women deliver<strong>in</strong>g before 34 <strong>we</strong>eks gestation received antenatal steroids. The majority<br />
of <strong>the</strong>se women (68%, 38/56), <strong>we</strong>re commenced on an <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose <strong>in</strong>fusion dur<strong>in</strong>g<br />
treatment. Ho<strong>we</strong>ver, a tenth of women did not have any change <strong>in</strong> glycaemic control management despite<br />
hav<strong>in</strong>g been given antenatal steroids (table 9.5).<br />
55
Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong><br />
Table 9.5<br />
Management of glycaemic control dur<strong>in</strong>g antenatal steroid adm<strong>in</strong>istration <strong>in</strong> women with diabetes deliver<strong>in</strong>g before<br />
34 <strong>we</strong>eks gestation<br />
Management of glycaemic control with antenatal steroid<br />
adm<strong>in</strong>istration<br />
No. of women receiv<strong>in</strong>g corticosteroids<br />
n(%)<br />
(N=56)<br />
No change from prior management 6 (11)<br />
Increased check<strong>in</strong>g of blood glucose only 3 (5)<br />
Subcutaneous <strong>in</strong>sul<strong>in</strong> regime changed* 3 (5)<br />
Intravenous <strong>in</strong>sul<strong>in</strong> and dextrose <strong>in</strong>fusion started* 38 (68)<br />
Information not available 6 (11)<br />
* Women who had a change <strong>in</strong> subcutaneous <strong>in</strong>sul<strong>in</strong> regime or who started <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose <strong>in</strong>fusion, also had<br />
<strong>in</strong>creased check<strong>in</strong>g of blood glucose.<br />
9.7 Discussion of mode and tim<strong>in</strong>g of delivery<br />
Women with pre-exist<strong>in</strong>g diabetes have high rates of obstetric <strong>in</strong>tervention, with a 39% <strong>in</strong>duction of labour<br />
rate and a 67% caes<strong>are</strong>an section rate. 5 It is important that women should be <strong>in</strong>volved <strong>in</strong> <strong>the</strong> decisionmak<strong>in</strong>g<br />
process regard<strong>in</strong>g mode and tim<strong>in</strong>g of delivery.<br />
9.7.1 Enquiry fi nd<strong>in</strong>gs<br />
A discussion about mode and tim<strong>in</strong>g of delivery was documented <strong>in</strong> <strong>the</strong> medical records for 86% (329/384)<br />
of women who delivered after 24+0 <strong>we</strong>eks gestation. The fi rst discussion occurred at a median of 35<br />
<strong>we</strong>eks (range 5 - 40 <strong>we</strong>eks). A lack of discussion of mode and tim<strong>in</strong>g of delivery was associated with poor<br />
<strong>pregnancy</strong> outcome (OR 4.0, 95% CI 1.2 - 12.7, adjusted for maternal age and deprivation, see Chapter 6).<br />
Additional case-control analysis (see Appendices C, D and E) sho<strong>we</strong>d an association with fetal or neonatal<br />
death from 20 <strong>we</strong>eks gestation but not with fetal congenital anomaly. Ho<strong>we</strong>ver, women who did not have<br />
a documented discussion delivered at an earlier gestation than women who had evidence of a discussion<br />
(median gestation at delivery 35 <strong>we</strong>eks versus 37 <strong>we</strong>eks), and <strong>the</strong>re may <strong>the</strong>refore have been o<strong>the</strong>r factors<br />
contribut<strong>in</strong>g to poor outcome.<br />
9.8 Maternity c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong>, labour and delivery<br />
Women with pre-exist<strong>in</strong>g diabetes have an <strong>in</strong>creased risk of fetal and maternal complications and it is<br />
important that <strong>the</strong>re is ongo<strong>in</strong>g fetal and maternal surveillance throughout <strong>pregnancy</strong>, labour and delivery<br />
to identify and manage any risks.<br />
Enquiry panels assessed that maternity c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong> was suboptimal for 51% of 430 women<br />
(58% of 215 cases and 44% of 215 controls), and <strong>the</strong>se women <strong>we</strong>re more likely to have a poor <strong>pregnancy</strong><br />
outcome (OR 1.9, 95% CI 1.2 - 2.8, adjusted for maternal age and deprivation, see Chapter 6). Additional<br />
case-control analysis (see Appendices C, D and E) sho<strong>we</strong>d an association with fetal or neonatal death<br />
from 20 <strong>we</strong>eks gestation but not with fetal congenital anomaly.<br />
56
Dur<strong>in</strong>g labour and delivery, <strong>the</strong> majority of women <strong>we</strong>re assessed to have optimal maternity c<strong>are</strong>. C<strong>are</strong><br />
was assessed to be suboptimal for 35% of 382 women , with no association bet<strong>we</strong>en suboptimal c<strong>are</strong> and<br />
<strong>pregnancy</strong> outcome (see Chapter 6).<br />
9.8.1 Panel comments on suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong><br />
Panels made 378 comments for 228 women, with nearly all of <strong>the</strong>se be<strong>in</strong>g about cl<strong>in</strong>ical c<strong>are</strong> issues.<br />
The two largest categories related to suboptimal fetal surveillance (ultrasound monitor<strong>in</strong>g of fetal growth<br />
and fetal heart rate monitor<strong>in</strong>g) and management of maternal risks. Problems with <strong>the</strong> antenatal diabetes<br />
multidiscipl<strong>in</strong>ary team, communication and <strong>the</strong> level of seniority of obstetric staff <strong>in</strong>volved <strong>in</strong> <strong>the</strong> woman’s<br />
c<strong>are</strong> <strong>we</strong>re also noted (table 9.6).<br />
Table 9.6<br />
Panel comments on suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong> for women with pre-exist<strong>in</strong>g diabetes (table<br />
conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation of free text)<br />
Women assessed to have suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g<br />
<strong>pregnancy</strong><br />
Good <strong>pregnancy</strong> outcome<br />
(N=95)<br />
Poor <strong>pregnancy</strong> outcome<br />
(N=125)<br />
No. of comments % of women No. of comments % of women<br />
Total comments* 147 - 209 -<br />
Suboptimal cl<strong>in</strong>ical practice 141 - 178 -<br />
Fetal surveillance 47 49 58 46<br />
Management of maternal risks 29 31 39 31<br />
Problem with <strong>the</strong> multidiscipl<strong>in</strong>ary team 17 18 28 22<br />
Need for more senior obstetrician <strong>in</strong>put 11 12 24 19<br />
Mode and tim<strong>in</strong>g of delivery 20 21 10 8<br />
No plan of c<strong>are</strong> 7 7 15 12<br />
Steroids not given/full course<br />
not completed 4 4 2 2<br />
O<strong>the</strong>r 6 6 2 2<br />
Communication 6 6 31 25<br />
* 22 comments <strong>we</strong>re made about social and lifestyle issues; <strong>the</strong>se comments <strong>are</strong> not <strong>in</strong>cluded <strong>in</strong> this table.<br />
9.8.2 Panel comments on suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g labour and delivery<br />
Enquiry panels made 245 comments for 150 women. The most frequent issues noted <strong>we</strong>re poor<br />
management of maternal risks, <strong>in</strong>appropriate decisions relat<strong>in</strong>g to delivery and <strong>in</strong>adequate fetal<br />
surveillance dur<strong>in</strong>g labour or delay <strong>in</strong> act<strong>in</strong>g on signs of fetal compromise (table 9.7).<br />
57
Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong><br />
Table 9.7<br />
Panel comments on suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g labour and delivery<br />
Women assessed to have suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g labour<br />
and delivery<br />
Good <strong>pregnancy</strong> outcome<br />
(N=72)<br />
Poor <strong>pregnancy</strong> outcome<br />
(N=78)<br />
No. of comments % of women No. of comments % of women<br />
Total comments* 123 - 120 -<br />
Suboptimal cl<strong>in</strong>ical practice 90 - 96 -<br />
Poor management of maternal risks 19 26 28 36<br />
Inappropriate decisions relat<strong>in</strong>g<br />
to delivery † 26 36 14 18<br />
Inadequate fetal surveillance/delay <strong>in</strong><br />
act<strong>in</strong>g on evidence of fetal compromise 20 28 18 23<br />
Insuffi cient senior obstetric <strong>in</strong>put 8 11 12 15<br />
Poor management of second stage 7 10 12 15<br />
Poor management of <strong>in</strong>duction/fi rst<br />
stage of labour 8 11 8 10<br />
No plan of management 2 3 4 5<br />
Communication 14 19 13 17<br />
Anaes<strong>the</strong>tic issues 4 6 3 4<br />
Resource 3 4 1 1<br />
O<strong>the</strong>r 12 17 7 9<br />
* 2 comments <strong>we</strong>re made about social and lifestyle issues; <strong>the</strong>se comments <strong>are</strong> not <strong>in</strong>cluded <strong>in</strong> this table.<br />
†<br />
<strong>in</strong>cludes <strong>in</strong>appropriate decision to expedite delivery and <strong>in</strong>appropriate mode of delivery.<br />
9.9 Postnatal c<strong>are</strong><br />
Women with diabetes will usually deliver <strong>in</strong> a consultant-led unit and be c<strong>are</strong>d for by maternity staff. Good<br />
l<strong>in</strong>es of communication bet<strong>we</strong>en maternity and diabetes teams <strong>are</strong> <strong>the</strong>refore important, and maternity<br />
staff should have easy access to expert advice about glycaemic control. A clear written plan for diabetes<br />
management <strong>in</strong> <strong>the</strong> woman’s medical records is important to help maternity staff provide appropriate c<strong>are</strong>.<br />
Cl<strong>in</strong>icians should take <strong>the</strong> opportunity to provide <strong>in</strong>formation and advice about contraception and <strong>the</strong><br />
importance of planned <strong>pregnancy</strong> before <strong>the</strong> woman is discharged from hospital. Women should have a<br />
follow up diabetes appo<strong>in</strong>tment after discharge from hospital to discuss ongo<strong>in</strong>g management of glycaemic<br />
control and cont<strong>in</strong>ue with o<strong>the</strong>r aspects of <strong>the</strong>ir diabetes c<strong>are</strong>.<br />
9.9.1 Enquiry fi nd<strong>in</strong>gs<br />
The majority of women, (81%, 312/383) deliver<strong>in</strong>g after 24 <strong>we</strong>eks gestation had a documented plan for<br />
post delivery diabetes management. Seventy three percent (280/383) of women had a follow up diabetes<br />
appo<strong>in</strong>tment arranged.<br />
58
Just 52% of 383 women (38% of 164 cases and 63% of 219 controls) <strong>we</strong>re documented to have had<br />
contraceptive advice provided before discharge from hospital. Women who had had a poor <strong>pregnancy</strong><br />
outcome <strong>we</strong>re more likely not to receive contraceptive advice than women with a good <strong>pregnancy</strong><br />
outcome (OR 4.2, 95% CI 2.4 - 7.4, adjusted for maternal age and deprivation, see Chapter 6)<br />
Enquiry panels assessed that 57% of 364 women (66% of 153 cases and 50% of 211 controls) deliver<strong>in</strong>g<br />
after 24 <strong>we</strong>eks gestation had suboptimal postnatal diabetes c<strong>are</strong> and advice. Women who had a poor<br />
<strong>pregnancy</strong> outcome <strong>we</strong>re more likely to have suboptimal postnatal diabetes c<strong>are</strong> (adjusted OR 1.8, 95%<br />
CI 1.2 - 2.7, adjusted for maternal age and deprivation, see Chapter 6).<br />
9.9.2 Panel comments on suboptimal postnatal diabetes c<strong>are</strong><br />
Panels made 267 comments for 207 women, with <strong>the</strong> majority of <strong>the</strong>se be<strong>in</strong>g related to suboptimal cl<strong>in</strong>ical<br />
c<strong>are</strong>. Concerns <strong>in</strong>cluded management of glycaemic control after delivery, <strong>in</strong>adequate plans of c<strong>are</strong> at<br />
discharge from hospital, lack of contact with <strong>the</strong> diabetes team and no contraceptive advice given to<br />
women (table 9.8).<br />
Table 9.8<br />
Panel comments about suboptimal postnatal diabetes c<strong>are</strong> (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation<br />
of free text)<br />
Women assessed to have suboptimal postnatal diabetes c<strong>are</strong><br />
Good <strong>pregnancy</strong> outcome<br />
(N=106)<br />
No. of comments % of women No. of<br />
comments<br />
Poor <strong>pregnancy</strong> outcome<br />
(N=101)<br />
% of women<br />
Total comments* 95 129<br />
Suboptimal cl<strong>in</strong>ical practice 95 - 129 -<br />
Suboptimal management of glycaemic control 40 38 31 31<br />
Inadequate plan of c<strong>are</strong> at discharge 24 23 36 36<br />
Lack of contact with diabetes team 15 14 30 30<br />
No contraceptive advice 14 13 29 29<br />
O<strong>the</strong>r 2 2 3 3<br />
* There <strong>we</strong>re 32 comments where <strong>the</strong> underly<strong>in</strong>g issues <strong>we</strong>re not described by panels, and 11 comments about social and lifestyle<br />
issues; <strong>the</strong>se comments <strong>are</strong> not <strong>in</strong>cluded <strong>in</strong> this table.<br />
9.10 Conclusions<br />
It is encourag<strong>in</strong>g that <strong>the</strong>re <strong>we</strong>re a number of <strong>are</strong>as of good practice identifi ed:<br />
• 78% of women <strong>we</strong>re monitored for nephropathy<br />
• 79% of women had evidence of glycaemic control targets for labour and delivery<br />
• 68% of women receiv<strong>in</strong>g antenatal steroids had an <strong>in</strong>sul<strong>in</strong> and dextrose <strong>in</strong>fusion commenced<br />
• 86% of women had a documented discussion about tim<strong>in</strong>g and mode of delivery<br />
• 65% of women had optimal maternity c<strong>are</strong> dur<strong>in</strong>g labour and delivery<br />
• 81% of women had a written plan for post-delivery diabetes management.<br />
59
Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong><br />
Ho<strong>we</strong>ver, <strong>the</strong>re <strong>we</strong>re a number of concerns about cl<strong>in</strong>ical c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong>. Nearly half of women<br />
<strong>in</strong> <strong>the</strong> enquiry did not have a ret<strong>in</strong>al exam<strong>in</strong>ation dur<strong>in</strong>g <strong>the</strong> fi rst trimester and <strong>the</strong>re <strong>we</strong>re concerns about<br />
failure to change <strong>in</strong>sul<strong>in</strong> regimes to achieve good glycaemic control, and a non-responsive local strategy<br />
of diabetes antenatal c<strong>are</strong>. A tenth of women did not have any additional <strong>in</strong>terventions to ensure good<br />
glycaemic control dur<strong>in</strong>g antenatal steroid adm<strong>in</strong>istration. Fetal surveillance was suboptimal for nearly half<br />
of babies with antenatal evidence of macrosomia, and this was associated with poor <strong>pregnancy</strong> outcome,<br />
specifi cally fetal or neonatal death from 20 <strong>we</strong>eks gestation (see Chapter 6 and Appendices C, D and E).<br />
It is disappo<strong>in</strong>t<strong>in</strong>g that women who had a poor <strong>pregnancy</strong> outcome <strong>we</strong>re more likely to have suboptimal<br />
diabetes c<strong>are</strong> after delivery and <strong>we</strong>re less likely to receive contraceptive advice prior to discharge<br />
from hospital. It is recognised that cl<strong>in</strong>icians <strong>are</strong> likely to need to provide more <strong>in</strong>tensive counsell<strong>in</strong>g to<br />
women who have had a fetal loss, stillbirth or a baby born with a congenital anomaly, and discussion<br />
about contraception <strong>in</strong> this situation can be diffi cult. Ho<strong>we</strong>ver, it is important that diabetes c<strong>are</strong> is not<br />
compromised for <strong>the</strong>se women, and discussion about future <strong>pregnancy</strong> preparation may help to m<strong>in</strong>imise<br />
<strong>the</strong> risk of adverse <strong>pregnancy</strong> outcome <strong>in</strong> <strong>the</strong> future.<br />
Some quotes from <strong>the</strong> panel discussions<br />
Suboptimal glycaemic control dur<strong>in</strong>g <strong>pregnancy</strong>:<br />
• 'HbA1C 10.7% - should have been put on <strong>in</strong>sul<strong>in</strong>.'<br />
• 'At 36 <strong>we</strong>eks HbA1c 8.6%. Insul<strong>in</strong> was changed to QDS at 28 <strong>we</strong>eks this should have<br />
been sooner.'<br />
• 'Fragmented C<strong>are</strong>, locum consultants. No notes from Diabetologist.'<br />
Suboptimal glycaemic control dur<strong>in</strong>g labour and delivery:<br />
• 'Slid<strong>in</strong>g scale not commenced until <strong>we</strong>ll established <strong>in</strong> labour and blood glucose high. Fixed<br />
slid<strong>in</strong>g scale that did not adequately ma<strong>in</strong>ta<strong>in</strong> blood glucose at acceptable levels.'<br />
• 'The pump became disconnected, <strong>the</strong> 3 way tap was turned off. No one noticed for some time<br />
until her BMs <strong>we</strong>nt up considerably.'<br />
<strong>Diabetes</strong> c<strong>are</strong> (exclud<strong>in</strong>g glycaemic control):<br />
• ‘Inadequate nephropathy monitor<strong>in</strong>g - no regular ur<strong>in</strong>e test<strong>in</strong>g, only 2 dipstick ur<strong>in</strong>e tests.<br />
No ret<strong>in</strong>al screen<strong>in</strong>g after 13 <strong>we</strong>eks.’<br />
• ‘Lack of evidence of holistic c<strong>are</strong>, seemed to be outside multidiscipl<strong>in</strong>ary service, no <strong>in</strong>formation<br />
about diabetes nurse specialist, dietetic or community team’s <strong>in</strong>put, no jo<strong>in</strong>t cl<strong>in</strong>ic.’<br />
Antenatal fetal surveillance:<br />
• ‘Noted <strong>in</strong>crease <strong>in</strong> abdom<strong>in</strong>al circumference with previous history of IUD and <strong>the</strong> next scan<br />
is arranged for 4 <strong>we</strong>eks. There should have been <strong>in</strong>creased surveillance.’<br />
60
• ‘No serial growth scans performed (not <strong>in</strong> protocol ei<strong>the</strong>r). The method of management; CTGs<br />
only, <strong>in</strong>appropriate.’<br />
• 'Stated USS good growth - despite AC >97th centile.'<br />
Maternity c<strong>are</strong>:<br />
• ‘Given steroids as outpatient.’<br />
• ‘Signifi cant hypertension was never treated; pre-eclampsia symptoms <strong>we</strong>re not addressed.’<br />
• ‘This lady was admitted to hospital on several occasions with vomit<strong>in</strong>g, but was not revie<strong>we</strong>d by<br />
<strong>the</strong> medical or diabetic team. The diagnosis of DKA was not picked up on one of her admissions.’<br />
Postnatal c<strong>are</strong><br />
• 'Given pre-delivery dose of <strong>in</strong>sul<strong>in</strong> post delivery, despite <strong>the</strong> Registrar record<strong>in</strong>g "use pre-delivery<br />
dose". The mo<strong>the</strong>r became hypoglycaemic.'<br />
• 'One BM stix <strong>in</strong> 3 days, no evidence of plan of c<strong>are</strong> and contraceptive advice left to GP.'<br />
9.11 Recommendations<br />
Cl<strong>in</strong>ical<br />
1. An <strong>in</strong>dividualised c<strong>are</strong> plan cover<strong>in</strong>g <strong>the</strong> <strong>pregnancy</strong> and postnatal period up to 6 <strong>we</strong>eks should be<br />
clearly documented <strong>in</strong> <strong>the</strong> notes, ideally us<strong>in</strong>g a standard template. The plan may require changes to<br />
be made depend<strong>in</strong>g on <strong>the</strong> cl<strong>in</strong>ical circumstances through <strong>pregnancy</strong>. As a m<strong>in</strong>imum, <strong>the</strong> c<strong>are</strong> plan<br />
should <strong>in</strong>clude:<br />
• Targets for glycaemic control<br />
• Ret<strong>in</strong>al screen<strong>in</strong>g schedule<br />
• Renal screen<strong>in</strong>g schedule<br />
• Fetal surveillance<br />
• Plan for delivery<br />
• <strong>Diabetes</strong> c<strong>are</strong> after delivery.<br />
2. The c<strong>are</strong> plan should be implemented from <strong>the</strong> outset of <strong>pregnancy</strong> by a multidiscipl<strong>in</strong>ary team<br />
present at <strong>the</strong> same time <strong>in</strong> <strong>the</strong> same cl<strong>in</strong>ic. As a m<strong>in</strong>imum, <strong>the</strong> multidiscipl<strong>in</strong>ary team should <strong>in</strong>clude<br />
an obstetrician, diabetes physician, diabetes specialist nurse, diabetes midwife and dietitian.<br />
3. Pregnancies with ultrasound evidence of macrosomia should have a clear management plan put <strong>in</strong><br />
place by a consultant obstetrician. This should <strong>in</strong>clude tim<strong>in</strong>g of follow-up scans, fetal surveillance<br />
and mode and tim<strong>in</strong>g of delivery.<br />
4. A c<strong>are</strong> plan for postnatal management should be clearly documented <strong>in</strong> <strong>the</strong> notes for all women.<br />
As a m<strong>in</strong>imum, this should <strong>in</strong>clude:<br />
• Plan for management of glycaemic control<br />
• Neonatal c<strong>are</strong><br />
• Contraception<br />
• Follow-up c<strong>are</strong> after discharge from hospital.<br />
61
Cl<strong>in</strong>ical c<strong>are</strong> issues: <strong>pregnancy</strong><br />
Audit and research<br />
5. Research should be carried out to <strong>in</strong>vestigate:<br />
• <strong>the</strong> most appropriate management strategy follow<strong>in</strong>g antenatal evidence of macrosomia <strong>in</strong> babies<br />
of women with diabetes<br />
• how <strong>best</strong> to achieve optimal blood glucose control dur<strong>in</strong>g <strong>pregnancy</strong>, labour and delivery.<br />
References<br />
1. Miller E, H<strong>are</strong> JW, Cloherty JP, Dunn PJ, Gleason RE, Soeldner JS, et al. Elevated maternal<br />
haemoglob<strong>in</strong> A1c <strong>in</strong> early <strong>pregnancy</strong> and major congenital anomalies <strong>in</strong> <strong>in</strong>fants of diabetic mo<strong>the</strong>r.<br />
N Engl J Med, 1981.304:1331-4.<br />
2. Mills JL, Simpson JL, Driscoll SG, Jovanovic-Peterson L, Van Allen M, Aarons JH, Metzger B, Bieber<br />
FR, Knopp RH, Holmes LB et al. Incidence of spontaneous abortion among normal women and<br />
<strong>in</strong>sul<strong>in</strong>-dependent diabetic women whose pregnancies <strong>we</strong>re identifi ed with<strong>in</strong> 21 days of conception.<br />
N Engl J Med, 1988: 319:1617-1623.<br />
3. Rey E, Attie C, Bon<strong>in</strong> A. The effects of fi rst-trimester diabetes control on <strong>the</strong> <strong>in</strong>cidence of<br />
macrosomia. Am J Obstet Gynecol, 1999; 181, 202-6.<br />
4. Taylor R, Lee C, Kyne-Grzebalski D, Marshall SM, Davison JM. Cl<strong>in</strong>ical outcomes of <strong>pregnancy</strong><br />
<strong>in</strong> women with type 1 diabetes. Obstet Gynecol, 2002; 99, 537 – 41.<br />
5. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Pregnancy <strong>in</strong> women with type 1 and<br />
type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
6. Recommendations for <strong>the</strong> management of pregnant women with diabetes (<strong>in</strong>clud<strong>in</strong>g gestational<br />
diabetes). <strong>Diabetes</strong> UK C<strong>are</strong> Recommendation. Updated June 2005.<br />
7. National Service Framework for <strong>Diabetes</strong> (England) Standards. Department of Health.<br />
The Stationery Offi ce: London; 2001.<br />
8. Sheth BP. Does <strong>pregnancy</strong> accelerate <strong>the</strong> rate of progression of diabetic ret<strong>in</strong>opathy?<br />
Current <strong>Diabetes</strong> Reports, Aug 2002: 2(4):327-30.<br />
9. Duckitt K, Harr<strong>in</strong>gton D. Risk factors for pre-eclampsia at antenatal book<strong>in</strong>g: systematic review<br />
of controlled studies. BMJ, 12 Mar 2005: 330(7491):565.<br />
10. Fischer MJ, Lehnerz SD, Hebert JR, Parikh CR. Kidney disease is an <strong>in</strong>dependent risk factor<br />
for adverse fetal and maternal outcomes <strong>in</strong> <strong>pregnancy</strong>. American Journal of Kidney Diseases.<br />
Mar 2004: 43(3):415-23.<br />
11. Irfan S, Ara<strong>in</strong> TM, Shaukat A, Shahid A. Effect of <strong>pregnancy</strong> on diabetic nephropathy and<br />
ret<strong>in</strong>opathy. J Coll Physicians Surg Pak: Feb 2004: 14(2):75-8.<br />
Commentary<br />
Stephen Walk<strong>in</strong>shaw<br />
Chair, CEMACH <strong>Diabetes</strong> Professional Advisory Group<br />
Consultant Obstetrician, Liverpool Women’s Hospital, Liverpool<br />
Although <strong>the</strong>re <strong>are</strong> many <strong>are</strong>as of good cl<strong>in</strong>ical practice dur<strong>in</strong>g <strong>pregnancy</strong> for women with diabetes,<br />
this chapter has highlighted some aspects of diabetes and maternity c<strong>are</strong> that <strong>are</strong> less impressive.<br />
62
The panel enquiries, which <strong>are</strong> <strong>in</strong> essence a detailed peer review of cl<strong>in</strong>ical c<strong>are</strong>, have identifi ed a number<br />
of underly<strong>in</strong>g issues which may help multidiscipl<strong>in</strong>ary teams to work towards improv<strong>in</strong>g c<strong>are</strong> and outcomes.<br />
It is surpris<strong>in</strong>g that b<strong>are</strong>ly half of women <strong>in</strong> <strong>the</strong> enquiry had optimal glycaemic control after <strong>the</strong> fi rst<br />
trimester. Some of <strong>the</strong> underly<strong>in</strong>g issues <strong>in</strong>cluded poor <strong>in</strong>tegration of c<strong>are</strong>, failure to follow up women and<br />
failure to change <strong>in</strong>sul<strong>in</strong> regimens to enable optimal glycaemic control. It should be feasible to address<br />
<strong>the</strong>se issues with<strong>in</strong> <strong>the</strong> organisation of multidiscipl<strong>in</strong>ary cl<strong>in</strong>ics without signifi cant additional resource.<br />
Similarly, improv<strong>in</strong>g <strong>the</strong> sett<strong>in</strong>g of blood glucose targets, ret<strong>in</strong>al and renal screen<strong>in</strong>g and more senior<br />
<strong>in</strong>volvement should be feasible with<strong>in</strong> exist<strong>in</strong>g local frameworks of c<strong>are</strong>, though ma<strong>in</strong>ta<strong>in</strong><strong>in</strong>g cont<strong>in</strong>uous<br />
senior <strong>in</strong>put at <strong>the</strong> cl<strong>in</strong>ic may be a challenge.<br />
Women with diabetes <strong>are</strong> a ‘captive’ group dur<strong>in</strong>g labour and delivery, and it cannot be acceptable that a<br />
large number <strong>we</strong>re considered to have suboptimal glycaemic control dur<strong>in</strong>g this time, especially given <strong>the</strong><br />
knowledge that <strong>the</strong> level of glycaemic control dur<strong>in</strong>g labour <strong>in</strong>fl uences <strong>the</strong> risk of neonatal hypoglycaemia.<br />
Panels noted delays <strong>in</strong> start<strong>in</strong>g <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong>, and <strong>in</strong>adequate dose regimens, which when taken<br />
toge<strong>the</strong>r with panels’ concerns about local guidel<strong>in</strong>es <strong>in</strong> Chapter 10, suggests that <strong>the</strong> organisation of<br />
diabetes c<strong>are</strong> on <strong>the</strong> labour ward needs improvement. Multidiscipl<strong>in</strong>ary teams need to consider how <strong>the</strong>y<br />
can cont<strong>in</strong>ue <strong>the</strong> high level of antenatal specialist <strong>in</strong>volvement through to <strong>the</strong> labour ward, and how <strong>the</strong>y<br />
can provide clear written guidance and practical tra<strong>in</strong><strong>in</strong>g for non-specialist staff.<br />
Suboptimal maternity c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong>, which was present <strong>in</strong> half of women <strong>in</strong> <strong>the</strong> enquiry, was<br />
associated with a two to threefold <strong>in</strong>crease <strong>in</strong> <strong>the</strong> risk of los<strong>in</strong>g a baby after 20 <strong>we</strong>eks. For babies with<br />
evidence of macrosomia, suboptimal fetal surveillance was strongly associated with an <strong>in</strong>creased risk<br />
of death after 20 <strong>we</strong>eks gestation. The ma<strong>in</strong> underly<strong>in</strong>g issues identifi ed <strong>we</strong>re poor antenatal fetal<br />
surveillance, poor management of maternal risks, and <strong>in</strong>appropriate decisions about mode and tim<strong>in</strong>g<br />
of delivery.<br />
Though <strong>the</strong>re is a relatively small evidence base for fetal surveillance <strong>in</strong> diabetic <strong>pregnancy</strong>, most women<br />
with diabetes have regular ultrasound scans and some form of fetal <strong>we</strong>ll-be<strong>in</strong>g monitor<strong>in</strong>g. There is,<br />
ho<strong>we</strong>ver, little po<strong>in</strong>t <strong>in</strong> any form of surveillance if no or <strong>in</strong>adequate action is taken <strong>in</strong> response to <strong>the</strong> results.<br />
It suggests that such surveillance is carried out ‘rout<strong>in</strong>ely’ <strong>in</strong> many cases without detailed consideration of<br />
<strong>the</strong> possible impact on <strong>the</strong> fetus, and perhaps echoes <strong>the</strong> panels’ comments about lack of senior <strong>in</strong>put.<br />
Similarly, it may be that all women with diabetes <strong>are</strong> regarded as high risk without any stratifi cation with<strong>in</strong><br />
<strong>the</strong> group, lead<strong>in</strong>g to poor management of <strong>in</strong>dividual risks and a blanket policy on mode and tim<strong>in</strong>g of<br />
delivery. Obstetric and midwifery members of <strong>the</strong> multidiscipl<strong>in</strong>ary team need to consider what tests and<br />
<strong>in</strong>terventions <strong>are</strong> actually needed, and what <strong>the</strong>se mean to <strong>the</strong> <strong>in</strong>dividual <strong>pregnancy</strong> and not for diabetic<br />
<strong>pregnancy</strong> <strong>in</strong> general. The NICE guidel<strong>in</strong>es on diabetes <strong>in</strong> <strong>pregnancy</strong>, currently under development, may<br />
give some direction to <strong>the</strong>se discussions.<br />
From <strong>the</strong> panels’ comments on postnatal c<strong>are</strong>, it does appear that <strong>the</strong> diabetes team is not as closely<br />
<strong>in</strong>volved with <strong>the</strong> woman’s c<strong>are</strong> after birth as before, even though 4 out of 5 women had a documented<br />
plan. Delivery of consistent quality <strong>in</strong> postnatal c<strong>are</strong> is a problem outwith <strong>pregnancy</strong> <strong>in</strong> women with<br />
diabetes, and this diffi cult service issue will be a challenge to improve.<br />
63
10. Cl<strong>in</strong>ical governance<br />
Learn<strong>in</strong>g po<strong>in</strong>ts<br />
• Only a fi fth of women <strong>we</strong>re reported to have had all members of <strong>the</strong> multidiscipl<strong>in</strong>ary team<br />
<strong>in</strong>volved <strong>in</strong> <strong>the</strong>ir c<strong>are</strong>.<br />
• There was poor documentation of obstetric and diabetes c<strong>are</strong> for more than half of<br />
women <strong>in</strong> <strong>the</strong> enquiry.<br />
• In a fi fth of cases <strong>the</strong>re <strong>we</strong>re concerns that <strong>the</strong> design of <strong>the</strong> maternity notes was not<br />
fi t for purpose for antenatal c<strong>are</strong> of a woman with diabetes.<br />
• There <strong>we</strong>re concerns about <strong>the</strong> standard of local maternity units’ diabetes guidel<strong>in</strong>es for nearly<br />
three quarters of women.<br />
10.1 Introduction<br />
Provid<strong>in</strong>g a high standard of cl<strong>in</strong>ical c<strong>are</strong> is a central tenet of cl<strong>in</strong>ical governance. This needs to be<br />
supported by effi cient referral pathways, multidiscipl<strong>in</strong>ary work<strong>in</strong>g, good documentation, evidencebased<br />
guidel<strong>in</strong>es and clear l<strong>in</strong>es of communication bet<strong>we</strong>en health professionals and bet<strong>we</strong>en health<br />
professionals and patients. The Cl<strong>in</strong>ical Negligence Scheme for Trusts (CNST), adm<strong>in</strong>istered by <strong>the</strong> NHS<br />
Litigation Authority (NHSLA), has defi ned m<strong>in</strong>imum standards for maternity units <strong>in</strong> all <strong>the</strong>se <strong>are</strong>as. This<br />
chapter exam<strong>in</strong>es some of <strong>the</strong> issues identifi ed by panels for women with type 1 and type 2 diabetes us<strong>in</strong>g<br />
maternity services.<br />
10.2 Access to maternity c<strong>are</strong><br />
Women with pre-exist<strong>in</strong>g diabetes should be referred promptly from primary c<strong>are</strong> to <strong>the</strong> diabetes specialist<br />
team as soon as <strong>pregnancy</strong> is confi rmed 1 , for review of glycaemic control, assessment for diabetes<br />
complications and a dat<strong>in</strong>g fi rst trimester ultrasound scan. It is encourag<strong>in</strong>g that women <strong>in</strong> <strong>the</strong> enquiry had<br />
<strong>the</strong>ir fi rst contact with a health professional at a median of 6+6 <strong>we</strong>eks, and <strong>the</strong>ir fi rst hospital appo<strong>in</strong>tment<br />
at 8+3 <strong>we</strong>eks.<br />
10.3 Multidiscipl<strong>in</strong>ary work<strong>in</strong>g<br />
Women with pre-exist<strong>in</strong>g diabetes require <strong>the</strong> cl<strong>in</strong>ical expertise of a number of different professionals<br />
dur<strong>in</strong>g <strong>pregnancy</strong>. The <strong>Diabetes</strong> NSF recommends that antenatal c<strong>are</strong> should be provided by a full<br />
multidiscipl<strong>in</strong>ary team compris<strong>in</strong>g an obstetrician, diabetes physician, diabetes specialist nurse, midwife<br />
and dietitian. 1 In <strong>the</strong> CEMACH survey of diabetes maternity services 2 , 63% of maternity units <strong>in</strong> England,<br />
Wales and Nor<strong>the</strong>rn Ireland reported a full multidiscipl<strong>in</strong>ary team, and <strong>the</strong>re had been an <strong>in</strong>crease <strong>in</strong><br />
specialist staff comp<strong>are</strong>d with <strong>the</strong> last national survey 8 years previously. 3 In particular, <strong>the</strong> availability of<br />
a dietitian <strong>in</strong> <strong>the</strong> antenatal cl<strong>in</strong>ic had doubled from 40% to 88% of units and <strong>the</strong> availability of a midwife<br />
specialist had tripled from 25% to 77% of units.<br />
64
10.3.1 Enquiry fi nd<strong>in</strong>gs<br />
Seventy five percent (329/441) of women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re reported to have c<strong>are</strong> provided <strong>in</strong> a comb<strong>in</strong>ed<br />
cl<strong>in</strong>ic. Ho<strong>we</strong>ver, only 22% of 441 women <strong>we</strong>re reported to have had all members of <strong>the</strong> multidiscipl<strong>in</strong>ary<br />
team <strong>in</strong>volved <strong>in</strong> <strong>the</strong>ir c<strong>are</strong>. The professionals most likely not to have been <strong>in</strong>volved <strong>we</strong>re <strong>the</strong> midwife and<br />
<strong>the</strong> dietitian (for 54% and 53% of 441 women respectively). This is surpris<strong>in</strong>g <strong>in</strong> view of <strong>the</strong> f<strong>in</strong>d<strong>in</strong>gs of <strong>the</strong><br />
previous CEMACH survey. A possible reason is that women <strong>we</strong>re not easily able to access dietitians and<br />
midwives even though <strong>the</strong>y <strong>we</strong>re members of <strong>the</strong> multidiscipl<strong>in</strong>ary team, perhaps due to patterns of work<strong>in</strong>g<br />
with<strong>in</strong> <strong>the</strong> antenatal cl<strong>in</strong>ic. Ho<strong>we</strong>ver, it is also possible that <strong>the</strong>re <strong>we</strong>re panel variations <strong>in</strong> <strong>in</strong>terpretation of <strong>the</strong><br />
term ‘midwife with special <strong>in</strong>terest <strong>in</strong> diabetes’ which was used <strong>in</strong> <strong>the</strong> enquiry pro forma.<br />
10.4 Documentation<br />
Clear documentation of c<strong>are</strong> given and plans of management enables different cl<strong>in</strong>icians to effectively<br />
follow up <strong>in</strong>dividual women. The CNST ‘Health Record’ standard states that a woman’s health record<br />
should provide a complete and contemporaneous record of her treatment and related features. 4<br />
10.4.1 Enquiry fi nd<strong>in</strong>gs<br />
Enquiry panels’ consensus was that <strong>the</strong>re <strong>we</strong>re defi ciencies <strong>in</strong> <strong>the</strong> standard of 44% of 436 obstetric notes<br />
and 51% of 439 diabetes notes.<br />
For both diabetes and obstetric notes, <strong>the</strong> ma<strong>in</strong> issue identifi ed for 55% and 61% of women respectively<br />
where defi ciencies <strong>we</strong>re identifi ed, was poor documentation of what c<strong>are</strong> had been given and <strong>the</strong> plan of<br />
c<strong>are</strong> (table 10.1). In many <strong>in</strong>stances diabetes <strong>in</strong>formation was so scanty that panels questioned whe<strong>the</strong>r<br />
<strong>the</strong> diabetes notes had been written elsewhere. In a fi fth of cases <strong>the</strong>re <strong>we</strong>re concerns that <strong>the</strong> design of<br />
<strong>the</strong> notes was not fi t for purpose for antenatal c<strong>are</strong> of a woman with diabetes.<br />
Table 10.1<br />
Panel comments on defi ciencies <strong>in</strong> obstetric and diabetes notes (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g<br />
categorisation of free text)<br />
Obstetric notes<br />
(N=192)<br />
<strong>Diabetes</strong> notes<br />
(N=224)<br />
No. of comments* % of notes No. of comments % of notes<br />
Total comments* 210 236<br />
Poor documentation of c<strong>are</strong> given<br />
or c<strong>are</strong> plans 105 55 136 61<br />
Poor design of notes 40 21 53 24<br />
Miss<strong>in</strong>g notes or CTGs 30 16 40 18<br />
Fetal growth not plotted on scans 14 7 - -<br />
Grade of staff not recorded 8 4 3 1<br />
Illegible writ<strong>in</strong>g 9 5 3 1<br />
Date/time not recorded 4 2 1 0<br />
* In 1 panel comment, <strong>the</strong> issue was not specifi ed.<br />
65
Cl<strong>in</strong>ical governance<br />
10.5 Maternity unit guidel<strong>in</strong>es<br />
CNST emphasises <strong>the</strong> importance of evidence-based, referenced, multidiscipl<strong>in</strong>ary guidel<strong>in</strong>es which <strong>are</strong><br />
easily accessible to <strong>the</strong> health professionals provid<strong>in</strong>g c<strong>are</strong>. 4 For each woman <strong>in</strong> <strong>the</strong> enquiry, panels <strong>we</strong>re<br />
asked to review <strong>the</strong> local maternity unit’s diabetes guidel<strong>in</strong>e (contemporaneous for 2002-2003) when <strong>the</strong>se<br />
had been provided by <strong>the</strong> unit. An <strong>in</strong>dividual unit’s guidel<strong>in</strong>e may have been revie<strong>we</strong>d more than once by<br />
panels, and <strong>the</strong> results <strong>are</strong> <strong>the</strong>refore presented as <strong>the</strong> proportion of women to whom any concerns related.<br />
Enquiry panels had concerns about local maternity units’ diabetes guidel<strong>in</strong>es for nearly three quarters<br />
(72%) of 386 women where unit guidel<strong>in</strong>es <strong>we</strong>re available.<br />
10.5.1 Panel comments on maternity unit diabetes guidel<strong>in</strong>es<br />
Panels made 386 comments about <strong>the</strong> local diabetes guidel<strong>in</strong>es for 278 women. The two most frequent<br />
issues cited <strong>we</strong>re no antenatal guidel<strong>in</strong>es and lack of clarity or <strong>in</strong>suffi cient detail (table 10.2). For nearly a<br />
quarter of <strong>the</strong> women, <strong>the</strong> panels’ view was that <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> regimes for labour <strong>we</strong>re <strong>in</strong>adequate,<br />
and for approximately a fi fth of <strong>the</strong> women <strong>the</strong> guidel<strong>in</strong>e did not <strong>in</strong>clude blood glucose targets. There was<br />
considered to be wrong or <strong>in</strong>appropriate advice <strong>in</strong> <strong>the</strong> guidel<strong>in</strong>es for more than a tenth of women assessed<br />
to have suboptimal local guidel<strong>in</strong>es.<br />
Table 10.2<br />
Panel comments on suboptimal maternity unit diabetes guidel<strong>in</strong>es (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g<br />
categorisation of free text)<br />
Number of women with suboptimal local<br />
guidel<strong>in</strong>es<br />
(N=278)<br />
No. of comments<br />
% of women<br />
Total comments* 386 -<br />
No antenatal guidel<strong>in</strong>e 80 29<br />
Not enough detail/not clear 70 25<br />
Inadequate <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> regime for labour 64 23<br />
Blood glucose issues (ma<strong>in</strong>ly no targets set) 57 21<br />
Wrong/<strong>in</strong>appropriate advice <strong>in</strong> guidel<strong>in</strong>e 35 13<br />
No postnatal guidel<strong>in</strong>e 24 9<br />
Out of date 19 7<br />
No guidance on management dur<strong>in</strong>g antenatal<br />
steroid adm<strong>in</strong>istration 16 6<br />
No advice on screen<strong>in</strong>g or management<br />
of diabetes complications 9 3<br />
Not referenced 6 2<br />
Recommends rout<strong>in</strong>e admission of baby to neonatal unit 6 2<br />
* hospital protocols not available or data miss<strong>in</strong>g for 56 women.<br />
66
10.6 Communication<br />
Effective communication bet<strong>we</strong>en health professionals, and bet<strong>we</strong>en health professionals and women, is<br />
vital to achiev<strong>in</strong>g a high standard of cl<strong>in</strong>ical c<strong>are</strong> which is responsive and puts <strong>the</strong> needs of <strong>the</strong> woman fi rst.<br />
10.6.1 Defi ciencies <strong>in</strong> communication bet<strong>we</strong>en health professionals<br />
Enquiry panels assessed that <strong>the</strong>re <strong>we</strong>re defi ciencies of communication bet<strong>we</strong>en health professionals for<br />
56% (222/398) of women (table 10.3). Poor communication bet<strong>we</strong>en maternity staff and diabetes specialist<br />
teams occurred ma<strong>in</strong>ly dur<strong>in</strong>g antenatal hospital admission and after delivery. Poor communication<br />
bet<strong>we</strong>en discipl<strong>in</strong>es alluded ma<strong>in</strong>ly to failure of <strong>the</strong> antenatal team to refer to o<strong>the</strong>r specialists such as<br />
renal physicians, cardiologists and ophthalmologists, with some comments made about poor transfer of<br />
<strong>in</strong>formation from midwifery and junior obstetric staff to more senior obstetricians dur<strong>in</strong>g labour. Problems<br />
noted with <strong>the</strong> multidiscipl<strong>in</strong>ary diabetes team <strong>in</strong>cluded a lack of a dedicated jo<strong>in</strong>t cl<strong>in</strong>ic and poor shar<strong>in</strong>g<br />
of <strong>in</strong>formation bet<strong>we</strong>en <strong>the</strong> obstetrician and diabetes physician.<br />
Table 10.3<br />
Panel comments on defi ciencies of communication bet<strong>we</strong>en health professionals car<strong>in</strong>g for women with type 1 and<br />
type 2 diabetes (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation of free text)<br />
Number of women with deficiencies <strong>in</strong><br />
communication<br />
(N=222)<br />
No. of comments<br />
% of women<br />
Total comments 258 -<br />
Poor communication bet<strong>we</strong>en secondary c<strong>are</strong> discipl<strong>in</strong>es 59 27<br />
Poor communication bet<strong>we</strong>en diabetes antenatal team<br />
and obstetric/midwifery staff 61 27<br />
Problems with<strong>in</strong> <strong>the</strong> multidiscipl<strong>in</strong>ary diabetes team 45 21<br />
Poor communication bet<strong>we</strong>en primary and secondary c<strong>are</strong> 44 20<br />
Poor documentation 20 9<br />
Issue not described 20 9<br />
Poor communication bet<strong>we</strong>en secondary c<strong>are</strong><br />
and o<strong>the</strong>r health or social agencies 9 4<br />
* 7 panel comments did not relate to communication issues<br />
10.6.2 Defi ciencies of communication bet<strong>we</strong>en health professionals and women<br />
Enquiry panels assessed that <strong>the</strong>re <strong>we</strong>re defi ciencies of communication bet<strong>we</strong>en health professionals<br />
and women for 47% (169/360) of women. The ma<strong>in</strong> issue seemed to be a lack of discussion bet<strong>we</strong>en<br />
professionals and women about risks and plans for c<strong>are</strong>, which occurred <strong>in</strong> nearly two thirds of <strong>the</strong> women<br />
for whom <strong>the</strong>re <strong>we</strong>re concerns (table 10.4).<br />
67
Cl<strong>in</strong>ical governance<br />
Table 10.4<br />
Panel comments on defi ciencies of communication bet<strong>we</strong>en health professionals and women with type 1 and type 2<br />
diabetes (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation of free text)<br />
Number of women with deficiencies <strong>in</strong><br />
communication<br />
(N=169)<br />
No. of comments % of women<br />
Total comments* 193<br />
Suboptimal discussion about risks 77 46<br />
Plan of c<strong>are</strong> not discussed 31 18<br />
Lack of professional <strong>in</strong>terpreters for women with language diffi culties 23 14<br />
Problem with<strong>in</strong> health service (poor <strong>in</strong>ter-professional communication,<br />
poor follow-up, cl<strong>in</strong>ician’s attitude etc) 19 11<br />
Communication affected by social/lifestyle factors relat<strong>in</strong>g to woman 17 10<br />
Wrong or confl ict<strong>in</strong>g <strong>in</strong>formation given 15 9<br />
Documentation 11 7<br />
* There <strong>we</strong>re 5 comments where <strong>the</strong> issues <strong>we</strong>re not described by panels<br />
10.7 Conclusions<br />
It is encourag<strong>in</strong>g that <strong>the</strong> majority of pregnant women with pre-exist<strong>in</strong>g diabetes fi rst accessed <strong>the</strong> hospital<br />
antenatal cl<strong>in</strong>ic with<strong>in</strong> <strong>the</strong> fi rst trimester of <strong>pregnancy</strong> and three quarters attended a comb<strong>in</strong>ed antenatal<br />
cl<strong>in</strong>ic. Ho<strong>we</strong>ver, just over a fi fth of women <strong>in</strong> <strong>the</strong> enquiry <strong>we</strong>re documented to have all members of <strong>the</strong><br />
multidiscipl<strong>in</strong>ary team <strong>in</strong>volved <strong>in</strong> <strong>the</strong>ir c<strong>are</strong>, with <strong>the</strong> dietitian and midwife be<strong>in</strong>g <strong>the</strong> professionals least<br />
likely to be <strong>in</strong>volved. While <strong>the</strong>re may have been variations <strong>in</strong> <strong>in</strong>terpretation of <strong>the</strong> term ‘midwife with<br />
special <strong>in</strong>terest <strong>in</strong> diabetes’, patterns of work<strong>in</strong>g should be revie<strong>we</strong>d by local multidiscipl<strong>in</strong>ary teams to<br />
ensure that all women <strong>are</strong> receiv<strong>in</strong>g equivalent c<strong>are</strong> and advice.<br />
In both <strong>the</strong> obstetric and diabetes antenatal notes, <strong>the</strong>re was poor documentation about what c<strong>are</strong> had<br />
been given and <strong>the</strong> plans for c<strong>are</strong>. Many panels had concerns that <strong>the</strong> design of <strong>the</strong> maternity hand held<br />
notes <strong>we</strong>re not fi t for purpose.<br />
For nearly two thirds of women, <strong>the</strong>re <strong>we</strong>re concerns about local diabetes guidel<strong>in</strong>es. The ma<strong>in</strong> issues<br />
<strong>we</strong>re a lack of clarity and <strong>in</strong>suffi cient detail, no antenatal guidel<strong>in</strong>es, <strong>in</strong>adequate <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong><br />
regimes and no guidance on blood glucose targets <strong>in</strong> labour.<br />
There <strong>we</strong>re concerns about communication bet<strong>we</strong>en health professionals for half of women <strong>in</strong> <strong>the</strong> enquiry.<br />
A particular issue appe<strong>are</strong>d to be poor l<strong>in</strong>es of communication bet<strong>we</strong>en <strong>the</strong> general maternity staff and <strong>the</strong><br />
diabetes specialist team, and poor <strong>in</strong>formation shar<strong>in</strong>g with<strong>in</strong> <strong>the</strong> diabetes multidiscipl<strong>in</strong>ary team.<br />
68
Some quotes from <strong>the</strong> panel discussions<br />
Documentation:<br />
• 'No difference from normal antenatal notes so no space to record observation plans relevant<br />
to diabetes.’<br />
• 'No diabetic entries <strong>in</strong> <strong>the</strong> obstetric notes (if she had attended ano<strong>the</strong>r unit <strong>the</strong>re would have<br />
been no record <strong>in</strong> her hand held notes).’<br />
• 'Big gaps <strong>in</strong> documentation. Very few glucose results <strong>in</strong>cluded <strong>in</strong> notes.'<br />
Communication:<br />
• 'Infrequent visits offered. Poor communication bet<strong>we</strong>en obstetricians and physicians dur<strong>in</strong>g<br />
<strong>pregnancy</strong>. Little or no dietitian <strong>in</strong>put.’<br />
• 'Prolonged delay after referral before be<strong>in</strong>g seen. Poor communication with diabetic team<br />
postnatally - did not seem to get response.’<br />
• 'Diffi culties with communication, <strong>in</strong>terpreter needed, relatives used <strong>in</strong>clud<strong>in</strong>g children.<br />
Missed opportunity re advice prior to Ramadan festival.'<br />
• 'Hypoglycaemia aw<strong>are</strong>ness not addressed and no app<strong>are</strong>nt warn<strong>in</strong>g re driv<strong>in</strong>g.’<br />
Guidel<strong>in</strong>es:<br />
• 'No target ranges. Slid<strong>in</strong>g scale not adequate, too restrictive, would not ma<strong>in</strong>ta<strong>in</strong> blood glucose<br />
levels appropriately.’<br />
• ‘No protocol for antenatal c<strong>are</strong> or for steroid adm<strong>in</strong>istration.’<br />
• ‘Wrong advice re Breastfeed<strong>in</strong>g - protocol stated that it <strong>in</strong>creased <strong>in</strong>sul<strong>in</strong> requirements and risk<br />
of <strong>in</strong>fection.’<br />
• 'Protocol suggest<strong>in</strong>g attendance at a comb<strong>in</strong>ed cl<strong>in</strong>ic beg<strong>in</strong>n<strong>in</strong>g only at 26/40 is considered<br />
<strong>in</strong>appropriate/poor practice.'<br />
• 'Rigid Delivery Day. No targets for blood glucose control. Rout<strong>in</strong>e admission of baby to NNU.<br />
10.8 Recommendations<br />
Cl<strong>in</strong>ical<br />
1. Commissioners should recognise <strong>the</strong> complexity of diabetes management immediately before<br />
and dur<strong>in</strong>g <strong>pregnancy</strong>, and ensure that <strong>the</strong> available service provision <strong>in</strong>cludes all members of <strong>the</strong><br />
multidiscipl<strong>in</strong>ary team.<br />
2. Patient pathways of c<strong>are</strong> <strong>in</strong>clud<strong>in</strong>g preconception counsell<strong>in</strong>g, <strong>pregnancy</strong> c<strong>are</strong> and post-<strong>pregnancy</strong><br />
management should be <strong>in</strong>corporated <strong>in</strong>to <strong>the</strong> cl<strong>in</strong>ical record.<br />
3. Services should review <strong>the</strong>ir local guidel<strong>in</strong>es. The NICE <strong>Diabetes</strong> <strong>in</strong> Pregnancy guidel<strong>in</strong>e, due to be<br />
published <strong>in</strong> November 2007, is anticipated to provide current evidence for <strong>best</strong> practice.<br />
69
Cl<strong>in</strong>ical governance<br />
4. In order to raise aw<strong>are</strong>ness, it is recommended that <strong>the</strong> specialist multidiscipl<strong>in</strong>ary team should<br />
provide regular educational days for all primary and secondary c<strong>are</strong> professionals likely to<br />
be <strong>in</strong>volved <strong>in</strong> <strong>the</strong> c<strong>are</strong> of women with diabetes <strong>in</strong> <strong>the</strong> local population, to cover all aspects of<br />
preconception, <strong>pregnancy</strong> and postnatal c<strong>are</strong>.<br />
Audit and research<br />
5. <strong>Diabetes</strong> networks should carry out regular audits of preconception and <strong>pregnancy</strong> services.<br />
References<br />
1. National Service Framework for <strong>Diabetes</strong> (England) Standards. Department of Health.<br />
The Stationery Offi ce: London: 2001.<br />
2. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Survey of maternity services for women<br />
with type 1 and type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH:<br />
London; 2004.<br />
3. Jard<strong>in</strong>e Brown C, Dawson A, Dodds R, Gamsu H, Gillmer M, Hall M, et al. Report of <strong>the</strong><br />
Pregnancy and Neonatal C<strong>are</strong> Group. Diabetic Med 1996;13:S43-S53.<br />
4. Cl<strong>in</strong>ical Negligence Scheme for Trusts Maternity Cl<strong>in</strong>ical Risk Management Standards.<br />
NHS Litigation Authority. April 2006.<br />
Commentary<br />
John Scarpello<br />
Deputy Medical Director, National Patient Safety Agency<br />
Consultant <strong>Diabetes</strong> Physician, University Hospital of North Staffordshire<br />
The CEMACH <strong>Diabetes</strong> Programme has raised important issues for those provid<strong>in</strong>g maternity services<br />
for women with diabetes. The CEMACH survey of diabetes maternity services sho<strong>we</strong>d an encourag<strong>in</strong>g<br />
<strong>in</strong>crease <strong>in</strong> <strong>the</strong> support available to women and most of <strong>the</strong> trusts surveyed had established comb<strong>in</strong>ed<br />
multidiscipl<strong>in</strong>ary cl<strong>in</strong>ics. Ho<strong>we</strong>ver, despite <strong>the</strong>se developments, <strong>are</strong>as of unsatisfactory practice rema<strong>in</strong>. All<br />
members of <strong>the</strong> multidiscipl<strong>in</strong>ary team <strong>we</strong>re only <strong>in</strong>volved <strong>in</strong> 22% of women <strong>in</strong> <strong>the</strong> enquiry and, surpris<strong>in</strong>gly,<br />
dietitians <strong>we</strong>re often absent. Dietetic support is important for both maternal and fetal nutrition but is also<br />
especially valuable <strong>in</strong> optimis<strong>in</strong>g glycaemic control, which is vital to a successful outcome.<br />
Women with type 1 and type 2 diabetes require c<strong>are</strong>ful pre-<strong>pregnancy</strong> assessment with excellent<br />
glycaemic control and folic acid supplementation before conception. Once <strong>pregnancy</strong> is confi rmed prompt<br />
referral is required to <strong>the</strong> multidiscipl<strong>in</strong>ary diabetes and obstetric team. The present enquiry has shown<br />
several <strong>are</strong>as where management is suboptimal. These <strong>in</strong>clude little evidence of pre-<strong>pregnancy</strong> plann<strong>in</strong>g<br />
and a lack of antenatal c<strong>are</strong> guidel<strong>in</strong>es.<br />
<strong>Diabetes</strong> management is now more often provided by primary c<strong>are</strong> ra<strong>the</strong>r than <strong>the</strong> secondary c<strong>are</strong><br />
specialist diabetes service. Whilst <strong>the</strong>re may be advantages to this model for many people with diabetes,<br />
<strong>the</strong> management of women with diabetes of childbear<strong>in</strong>g age demands agreed patient pathways and jo<strong>in</strong>t<br />
70
work<strong>in</strong>g bet<strong>we</strong>en primary and secondary providers. The enquiry has found evidence of poor documentation<br />
<strong>in</strong> cl<strong>in</strong>ical records, and <strong>in</strong> many cases <strong>the</strong> design of <strong>the</strong> maternity notes was described as not fi t for<br />
purpose. The enquiry has also highlighted defi ciencies <strong>in</strong> communication bet<strong>we</strong>en <strong>the</strong> multidiscipl<strong>in</strong>ary<br />
team and o<strong>the</strong>r discipl<strong>in</strong>es, for example, general maternity staff, renal physicians, cardiologists and<br />
ophthalmologists.<br />
Providers of diabetes maternity services should ensure that agreed standards have been documented<br />
<strong>in</strong> <strong>the</strong> patient c<strong>are</strong> records, <strong>in</strong>clud<strong>in</strong>g records of diabetes complications, glycaemic control and blood<br />
pressure. Postnatal c<strong>are</strong> plans should <strong>in</strong>clude contraceptive advice, <strong>in</strong>sul<strong>in</strong> management while<br />
breastfeed<strong>in</strong>g and targets for glycaemic control. Those provid<strong>in</strong>g diabetes maternity services will need to<br />
demonstrate that <strong>the</strong>ir multidiscipl<strong>in</strong>ary team is work<strong>in</strong>g to agreed patient pathways and evidence-based<br />
standards. The multi-professional team must <strong>in</strong>clude specialists (diabetes specialist nurses, obstetric and<br />
diabetology consultants, midwives and dietitians) tra<strong>in</strong>ed <strong>in</strong> <strong>the</strong> management of diabetes <strong>pregnancy</strong>.<br />
Unfortunately, <strong>the</strong> outcomes of <strong>pregnancy</strong> for women with diabetes rema<strong>in</strong> poor comp<strong>are</strong>d to outcomes for<br />
<strong>the</strong> general maternity population. This report challenges policy makers and commissioners to improve <strong>the</strong><br />
services provided to this high risk group of women.<br />
71
11. A comparison of type 1 and type 2 diabetes<br />
Learn<strong>in</strong>g po<strong>in</strong>ts<br />
• Women with type 2 diabetes <strong>in</strong> <strong>pregnancy</strong> <strong>we</strong>re more likely to be obese comp<strong>are</strong>d to women<br />
with type 1 diabetes.<br />
• Planned <strong>pregnancy</strong> rates <strong>we</strong>re similar for women with type 1 and type 2 diabetes but women<br />
with type 2 diabetes <strong>we</strong>re less likely to have evidence of contraceptive use <strong>in</strong> <strong>the</strong> 12 months<br />
before <strong>pregnancy</strong>.<br />
• Women with type 2 diabetes <strong>we</strong>re less likely than women with type 1 diabetes to have had<br />
a ret<strong>in</strong>al assessment or test for album<strong>in</strong>uria <strong>in</strong> <strong>the</strong> 12 months before <strong>pregnancy</strong>.<br />
• Women with type 1 diabetes <strong>in</strong> <strong>pregnancy</strong> <strong>we</strong>re more likely to have ret<strong>in</strong>opathy, recurrent<br />
hypoglycaemia and severe hypoglycaemic episodes than women with type 2 diabetes.<br />
Never<strong>the</strong>less, a fi fth of women with type 2 diabetes had recurrent hypoglycaemia and<br />
5% had new ret<strong>in</strong>opathy <strong>in</strong> <strong>pregnancy</strong>.<br />
• Women with type 2 diabetes <strong>we</strong>re less likely than women with type 1 diabetes to have<br />
a ret<strong>in</strong>al assessment <strong>in</strong> <strong>the</strong> fi rst trimester of <strong>pregnancy</strong> and less likely to receive postnatal<br />
contraceptive advice.<br />
11.1 Introduction<br />
The prevalence of type 2 diabetes is <strong>in</strong>creas<strong>in</strong>g 1 and <strong>the</strong> CEMACH report on 3808 pregnancies <strong>in</strong> women<br />
with pre-exist<strong>in</strong>g diabetes <strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland found that more than a quarter (27%)<br />
of women with pre-exist<strong>in</strong>g diabetes had type 2 diabetes. 2 Women with type 2 diabetes <strong>we</strong>re a very<br />
different group to women with type 1 diabetes be<strong>in</strong>g more likely to be older, multiparous, from a Black,<br />
Asian and O<strong>the</strong>r ethnic m<strong>in</strong>ority group and resident <strong>in</strong> an <strong>are</strong>a of social deprivation. 2 Women with<br />
type 2 diabetes <strong>we</strong>re also less likely to have had pre-<strong>pregnancy</strong> counsell<strong>in</strong>g, preconception folic acid<br />
and a test of glycaemic control <strong>in</strong> <strong>the</strong> 6 months before <strong>pregnancy</strong>. 2<br />
The enquiry module of <strong>the</strong> CEMACH <strong>Diabetes</strong> programme <strong>the</strong>refore set out to provide additional<br />
<strong>in</strong>formation about <strong>the</strong> differences bet<strong>we</strong>en women with type 1 and type 2 diabetes, <strong>in</strong> terms of cl<strong>in</strong>ical<br />
characteristics, social and lifestyle issues, and <strong>the</strong> c<strong>are</strong> provided to women.<br />
11.2 Methodology<br />
All women selected for <strong>the</strong> ma<strong>in</strong> enquiry as <strong>the</strong> control group (n=220) <strong>we</strong>re <strong>in</strong>cluded <strong>in</strong> <strong>the</strong> analyses for this<br />
chapter. In addition, 79 extra type 2 diabetic pregnancies result<strong>in</strong>g <strong>in</strong> a good outcome <strong>we</strong>re also <strong>in</strong>cluded<br />
(see Chapter 4). This gave a total of 170 women with type 1 diabetes and 127 women with type 2 diabetes,<br />
which represented 7.2% and 14.4% of all women with type 1 diabetes and type 2 diabetes respectively<br />
hav<strong>in</strong>g a good <strong>pregnancy</strong> outcome <strong>in</strong> <strong>the</strong> full descriptive study population of 3808 pregnancies. In order<br />
to analyse a representative sample of women with type 1 and type 2 diabetes from <strong>the</strong> descriptive study,<br />
72
<strong>we</strong> <strong>the</strong>refore selected 7.2% of pregnancies to women with type 1 diabetes result<strong>in</strong>g <strong>in</strong> a poor <strong>pregnancy</strong><br />
outcome and 14.4% of pregnancies to women with type 2 diabetes with a poor <strong>pregnancy</strong> outcome.<br />
This chapter <strong>the</strong>refore relates to 181 women with type 1 diabetes (170 with good <strong>pregnancy</strong> outcome and<br />
11 with poor <strong>pregnancy</strong> outcome) and 137 women with type 2 diabetes (127 with good <strong>pregnancy</strong> outcome<br />
and 10 with poor <strong>pregnancy</strong> outcome).<br />
11.3 Cl<strong>in</strong>ical characteristics<br />
11.3.1 Body Mass Index<br />
Women with type 2 diabetes <strong>we</strong>re more likely to have a high Body Mass Index (BMI) than women with type<br />
1 diabetes (χ2 test for trend p
A comparison of type 1 and type 2 diabetes<br />
11.3.3 Ret<strong>in</strong>opathy <strong>in</strong> <strong>pregnancy</strong><br />
Women with pre-exist<strong>in</strong>g diabetes <strong>are</strong> at risk of deterioration of exist<strong>in</strong>g ret<strong>in</strong>opathy and development<br />
of new ret<strong>in</strong>opathy dur<strong>in</strong>g <strong>pregnancy</strong>. 3,4<br />
In <strong>the</strong> enquiry, ret<strong>in</strong>opathy was present <strong>in</strong> more women with type 1 diabetes than <strong>in</strong> type 2 diabetes<br />
(p
11.4 Preconception behaviour<br />
The CEMACH report on 3808 pregnancies <strong>in</strong> women with pre-exist<strong>in</strong>g diabetes found a poor level of<br />
<strong>pregnancy</strong> preparation, which was more marked for women with type 2 diabetes. 2 The enquiry module<br />
provided <strong>the</strong> opportunity to exam<strong>in</strong>e differences <strong>in</strong> o<strong>the</strong>r aspects of preconception behaviour.<br />
11.4.1 Planned <strong>pregnancy</strong> and contraceptive use<br />
Planned <strong>pregnancy</strong> rates <strong>we</strong>re similar for women with type 1 diabetes (60% of 121 women) and type 2<br />
diabetes (62% of 84 women) (p=0.73, table 11.5), comp<strong>are</strong>d to a planned <strong>pregnancy</strong> rate of 58% <strong>in</strong> <strong>the</strong><br />
UK <strong>in</strong> 2001-2002. 6 Ho<strong>we</strong>ver, fe<strong>we</strong>r women with type 2 diabetes had evidence of contraceptive use <strong>in</strong> <strong>the</strong><br />
12 months prior to <strong>pregnancy</strong> (p=0.001, table 11.5). This suggests that for women with type 2 diabetes,<br />
plann<strong>in</strong>g a <strong>pregnancy</strong> does not necessarily equate to <strong>the</strong> use of contraception when not actively try<strong>in</strong>g to<br />
conceive. This may be l<strong>in</strong>ked to cultural beliefs and attitudes, and health professionals need to explore<br />
<strong>the</strong>se issues dur<strong>in</strong>g annual diabetes reviews and pre-<strong>pregnancy</strong> counsell<strong>in</strong>g.<br />
11.4.2 Folic acid<br />
In <strong>the</strong> 2005 CEMACH report, 39% of all women <strong>we</strong>re documented <strong>in</strong> <strong>the</strong> maternity notes or medical<br />
professional correspondence to have commenced folic acid before <strong>pregnancy</strong>, with fe<strong>we</strong>r women with<br />
type 2 diabetes documented to have started folic acid <strong>in</strong> <strong>the</strong> preconception period. 2 For <strong>the</strong> enquiry<br />
module, general practitioners and <strong>the</strong> adult diabetes service <strong>we</strong>re asked to provide <strong>in</strong>formation on folic<br />
acid use before <strong>pregnancy</strong>. A higher rate of preconception folic acid use than for <strong>the</strong> full cohort was<br />
reported (49% of women with type 1 diabetes and 45% of women with type 2 diabetes), and <strong>the</strong>re was<br />
no observed difference bet<strong>we</strong>en folic acid use <strong>in</strong> <strong>the</strong> two groups of women (p=0.60, Table 11.5).<br />
The difference <strong>in</strong> fi nd<strong>in</strong>gs bet<strong>we</strong>en <strong>the</strong> descriptive study and <strong>the</strong> enquiry may be due to <strong>the</strong> fact that <strong>the</strong><br />
<strong>in</strong>formation on folic acid <strong>in</strong> <strong>the</strong> descriptive study was dependent on documentation <strong>in</strong> <strong>the</strong> maternity notes,<br />
whereas <strong>in</strong> <strong>the</strong> enquiry, adult diabetes services and general practitioners <strong>we</strong>re approached for <strong>in</strong>formation.<br />
It is also possible that health professionals <strong>we</strong>re less likely to document folic acid use <strong>in</strong> <strong>the</strong> maternity<br />
notes or general medical records for women with type 2 diabetes than for women with type 1 diabetes,<br />
perhaps due to issues such as language diffi culties.<br />
Table 11.5<br />
Preconception behaviour <strong>in</strong> women with pre-exist<strong>in</strong>g diabetes<br />
Women with type 1 diabetes<br />
n/N (%)<br />
Women with type 2 diabetes<br />
n/N (%)<br />
p-value<br />
Planned <strong>pregnancy</strong> 72/121 (60) 52/84 (62) 0.73<br />
Evidence of contraceptive use <strong>in</strong> <strong>the</strong> 12<br />
months prior to <strong>pregnancy</strong> 61/104 (59) 21/65 (32) 0.001<br />
Evidence of preconception folic acid 54/110 (49) 32/71 (45) 0.60<br />
Smok<strong>in</strong>g 41/150 (27) 22/108 (20) 0.20<br />
Assessment of suboptimal approach of<br />
<strong>the</strong> woman to manag<strong>in</strong>g her diabetes<br />
83/135 (61) 51/88 (60) 0.60<br />
before <strong>pregnancy</strong><br />
Assessment of suboptimal approach of<br />
<strong>the</strong> woman to manag<strong>in</strong>g her diabetes<br />
dur<strong>in</strong>g <strong>pregnancy</strong><br />
50/171 (29) 36/124 (29) 0.97<br />
75
A comparison of type 1 and type 2 diabetes<br />
11.5 Preconception c<strong>are</strong> <strong>in</strong> <strong>the</strong> 12 months prior to <strong>pregnancy</strong><br />
There <strong>we</strong>re no differences bet<strong>we</strong>en women with type 1 and type 2 diabetes <strong>in</strong> terms of <strong>the</strong> contraceptive<br />
advice, specifi c diabetes advice and <strong>in</strong>formation about <strong>pregnancy</strong> risks and surveillance provided by<br />
cl<strong>in</strong>icians before <strong>pregnancy</strong> (table 11.6) Ho<strong>we</strong>ver, women with type 2 diabetes <strong>we</strong>re less likely to have a<br />
ret<strong>in</strong>al exam<strong>in</strong>ation and assessment of album<strong>in</strong>uria than women with type 1 diabetes <strong>in</strong> <strong>the</strong> 12 months<br />
before <strong>pregnancy</strong> (p=0.004, p=0.04 respectively, table 11.6).<br />
Table 11.6<br />
Differences <strong>in</strong> preconception c<strong>are</strong> bet<strong>we</strong>en women with type 1 and type 2 diabetes<br />
Women with type 1<br />
diabetes<br />
n/N (%)<br />
Women with type 2<br />
diabetes<br />
n/N (%)<br />
p-value<br />
No contraceptive advice given 18/76 (24) 18/44 (41) 0.05<br />
No recorded discussion of <strong>the</strong> follow<strong>in</strong>g<br />
specifi c diabetes issues:<br />
Alcohol <strong>in</strong>take 16/57 (28) 8/30 (27) 0.09<br />
Diet 10/82 (12) 5/56 (9) 0.55<br />
Poor glycaemic control 12/102 (12) 4/60 (7) 0.29<br />
Ret<strong>in</strong>opathy 17/80 (21) 11/37 (30) 0.31<br />
Nephropathy 21/64 (33) 14/29 (48) 0.15<br />
Hypertension 19/64 (30) 11/32 (34) 0.64<br />
No recorded discussion of <strong>the</strong> follow<strong>in</strong>g<br />
<strong>pregnancy</strong> issues:<br />
Increased diabetes surveillance 7/109 (6) 4/57 (7) 0.88<br />
Increased <strong>pregnancy</strong> surveillance 8/109 (7) 4/56 (7) 0.96<br />
Increased risk of <strong>in</strong>duction 13/95 (14) 8/40 (20) 0.36<br />
Possible caes<strong>are</strong>an section 11/93 (12) 6/47 (13) 0.87<br />
Fetal risks <strong>in</strong> diabetic <strong>pregnancy</strong> 7/97 (7) 4/48 (8) 0.81<br />
No dietetic review 87/110 (79) 19/77 (25) 0.19<br />
No assessment of <strong>the</strong> follow<strong>in</strong>g diabetes<br />
complications <strong>in</strong> <strong>the</strong> 12 months prior to<br />
<strong>pregnancy</strong>:<br />
Basel<strong>in</strong>e ret<strong>in</strong>al exam<strong>in</strong>ation 12/122 (10) 17/66 (26) 0.004<br />
Basel<strong>in</strong>e test of renal function 10/115 (9) 21/175 (12) 0.06<br />
Assessment of album<strong>in</strong>uria 20/92 (22) 21/56 (38) 0.04<br />
Assessment of suboptimal preconception<br />
c<strong>are</strong> (apart from glycaemic control) 72/116 (62) 53/72 (74) 0.1<br />
11.6 Glycaemic control<br />
There was no difference <strong>in</strong> <strong>the</strong> proportion of women with type 1 or type 2 diabetes hav<strong>in</strong>g a test of<br />
glycaemic control <strong>in</strong> <strong>the</strong> 12 months before <strong>pregnancy</strong> (table 11.7). This was different to <strong>the</strong> fi nd<strong>in</strong>gs of <strong>the</strong><br />
descriptive study, where women with type 2 diabetes <strong>we</strong>re less likely than women with type 1 diabetes<br />
to have documented evidence of a pre-<strong>pregnancy</strong> test of glycaemic control. 2 This may be because <strong>the</strong><br />
76
enquiry related to a 12 month prior to <strong>pregnancy</strong> ra<strong>the</strong>r than 6 months as for <strong>the</strong> descriptive study. Also, <strong>in</strong><br />
<strong>the</strong> descriptive study, <strong>in</strong>formation was dependent on documentation <strong>in</strong> <strong>the</strong> maternity notes whereas <strong>in</strong> <strong>the</strong><br />
enquiry, <strong>the</strong> adult diabetes service and general practitioner <strong>we</strong>re also approached for <strong>in</strong>formation, and this<br />
may have resulted <strong>in</strong> <strong>in</strong>creased ascerta<strong>in</strong>ment.<br />
Women with type 1 diabetes <strong>we</strong>re more likely than women with type 2 diabetes to have suboptimal<br />
preconception glycaemic control as assessed by enquiry panels (table 11.7). This was similar to <strong>the</strong><br />
descriptive study, where only 24% of 1081 women with type 1 diabetes had a median HbA1c less than<br />
7% prior to <strong>pregnancy</strong> comp<strong>are</strong>d to 41% of 303 women with type 2 diabetes. 2<br />
Fe<strong>we</strong>r women with type 2 diabetes received <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose dur<strong>in</strong>g delivery (table 11.7).<br />
This fi nd<strong>in</strong>g may partly refl ect <strong>the</strong> fact that a proportion of women with type 2 diabetes do not require<br />
<strong>in</strong>sul<strong>in</strong> dur<strong>in</strong>g <strong>pregnancy</strong>. Also, women with type 2 diabetes <strong>we</strong>re more likely to be multiparous 2 , and <strong>the</strong>re<br />
may have been no opportunity <strong>in</strong> labour to commence <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose.<br />
Table 11.7<br />
Differences <strong>in</strong> factors related to glycaemic control bet<strong>we</strong>en women with type 1 and type 2 diabetes<br />
Women with type 1<br />
diabetes<br />
n/N (%)<br />
Women with type 2<br />
diabetes<br />
n/N (%)<br />
p-value<br />
No test of glycaemic control <strong>in</strong> <strong>the</strong> 12<br />
months prior to <strong>pregnancy</strong> 20/120 (17) 14/73 (19) 0.66<br />
No evidence of local targets set for<br />
glycaemic control 24/73 (33) 11/34 (32) 0.96<br />
Assessment of suboptimal<br />
preconception glycaemic control 105/140 (75) 58/97 (60) 0.013<br />
Assessment of suboptimal 1st<br />
trimester glycaemic control 104/160 (65) 66/122 (54) 0.064<br />
Assessment of suboptimal glycaemic<br />
control after 1st trimester 71/174 (41) 46/130 (35) 0.34<br />
Assessment of suboptimal blood<br />
glucose control dur<strong>in</strong>g labour and<br />
78/165 (47) 49/120 (41) 0.28<br />
delivery<br />
No <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose<br />
dur<strong>in</strong>g labour and/or delivery 18/180 (10) 38/133 (29)
A comparison of type 1 and type 2 diabetes<br />
Table 11.8<br />
Differences <strong>in</strong> maternity c<strong>are</strong> dur<strong>in</strong>g <strong>the</strong> antenatal period bet<strong>we</strong>en women with type 1 and type 2 diabetes<br />
Women with type 1<br />
diabetes<br />
n/N (%)<br />
Women with type 2<br />
diabetes<br />
n/N (%)<br />
p-value<br />
Assessment of suboptimal fetal<br />
monitor<strong>in</strong>g (with antenatal evidence<br />
2/11 (18) 1/11 (9) 0.53<br />
of growth restricted baby)<br />
Assessment of suboptimal fetal<br />
monitor<strong>in</strong>g (with antenatal evidence<br />
19/32 (59) 16/45 (36) 0.68<br />
of big baby > 90th centile)<br />
No discussion of mode and tim<strong>in</strong>g<br />
of delivery 5/164 (3) 4/122 (3) 0.91<br />
No adm<strong>in</strong>istration of corticosteroids 9/28 (32) 8/24 (33) 0.93<br />
Assessment of suboptimal maternity<br />
c<strong>are</strong> dur<strong>in</strong>g <strong>the</strong> antenatal period 76/177 (43) 70/131 (53) 0.07<br />
Assessment of suboptimal maternity<br />
c<strong>are</strong> dur<strong>in</strong>g labour and delivery 59/178 (33) 56/131 (43) 0.08<br />
Table 11.9<br />
Differences <strong>in</strong> diabetes c<strong>are</strong> (exclud<strong>in</strong>g glycaemic control) dur<strong>in</strong>g <strong>pregnancy</strong> bet<strong>we</strong>en women with type 1 and type 2<br />
diabetes<br />
Women with type 1<br />
diabetes<br />
n/N (%)<br />
Women with type 2<br />
diabetes<br />
n/N (%)<br />
p-value<br />
No ret<strong>in</strong>al assessment 33/148 (22) 42/117 (36) 0.02<br />
No referral to ophthalmologist<br />
(if ret<strong>in</strong>opathy present) 20/43 (47) 5/9 (56) 0.62<br />
No monitor<strong>in</strong>g for nephropathy 24/169 (14) 21/128 (16) 0.6<br />
No test of renal function<br />
(if nephropathy present) 3/12 (25) 3/6 (50) 0.29<br />
Assessment of suboptimal<br />
diabetes c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong> 96/169 (57) 49/120 (41) 0.28<br />
11.8 Postnatal c<strong>are</strong><br />
Women with type 2 diabetes <strong>we</strong>re less likely to receive postnatal contraceptive advice than women with<br />
type 1 diabetes (table 11.10). This may have been due partly to language diffi culties and also perceived<br />
differences <strong>in</strong> cultural attitudes to contraception. All women with pre-exist<strong>in</strong>g diabetes should receive<br />
advice about contraception soon after delivery <strong>in</strong> order to prevent future unplanned pregnancies, and it<br />
should be agreed locally as to which professionals <strong>are</strong> <strong>best</strong> placed to provide this advice <strong>in</strong> <strong>the</strong> puerperium.<br />
78
Table 11.10<br />
Differences <strong>in</strong> postnatal c<strong>are</strong> bet<strong>we</strong>en women with type 1 and type 2 diabetes<br />
Women with type 1<br />
diabetes<br />
n/N (%)<br />
Women with type 2<br />
diabetes<br />
n/N (%)<br />
p-value<br />
No postnatal contraceptive advice 21/137 (15) 31/105 (30) 0.008<br />
No written plan for post-delivery<br />
diabetes management 20/156 (13) 15/115 (13) 0.95<br />
Assessment of suboptimal<br />
postnatal diabetes c<strong>are</strong> 93/177 (53) 59/127 (46) 0.3<br />
11.9 Conclusions<br />
The comparison of women with type 1 and type 2 diabetes has shown some differences <strong>in</strong> cl<strong>in</strong>ical<br />
characteristics (Body Mass Index, ret<strong>in</strong>opathy and frequency and severity of hypoglycaemia <strong>in</strong> <strong>pregnancy</strong>)<br />
which <strong>are</strong> to be expected from <strong>the</strong> difference <strong>in</strong> disease profi les bet<strong>we</strong>en <strong>the</strong> two groups of women.<br />
It is concern<strong>in</strong>g that women with type 2 diabetes <strong>we</strong>re less likely than women with type 1 diabetes to have<br />
a ret<strong>in</strong>al assessment <strong>in</strong> <strong>the</strong> fi rst trimester (or at book<strong>in</strong>g if later), especially s<strong>in</strong>ce ret<strong>in</strong>opathy was a new<br />
fi nd<strong>in</strong>g <strong>in</strong> fi ve out of <strong>the</strong> n<strong>in</strong>e women with type 2 diabetes who had ret<strong>in</strong>opathy <strong>in</strong> <strong>pregnancy</strong>. This may<br />
refl ect a perception by health professionals that type 2 diabetes is less likely to cause complications than<br />
type 1 diabetes, and highlights <strong>the</strong> importance of early and regular ret<strong>in</strong>al assessment for all women with<br />
pre-exist<strong>in</strong>g diabetes.<br />
Before <strong>pregnancy</strong>, women with type 2 diabetes <strong>we</strong>re less likely than women with type 1 diabetes to have a<br />
ret<strong>in</strong>al assessment or test for album<strong>in</strong>uria <strong>in</strong> <strong>the</strong> 12 months before <strong>pregnancy</strong>. Women with type 2 diabetes<br />
<strong>are</strong> more likely to be managed <strong>in</strong> primary c<strong>are</strong>, and this fi nd<strong>in</strong>g may <strong>the</strong>refore refl ect a lack of aw<strong>are</strong>ness<br />
by primary c<strong>are</strong> professionals of <strong>the</strong> importance of screen<strong>in</strong>g for diabetes complications <strong>in</strong> women with<br />
type 2 diabetes. There may also be diffi culties <strong>in</strong> access<strong>in</strong>g <strong>in</strong>vestigations such as ret<strong>in</strong>al photographs that<br />
<strong>are</strong> usually provided <strong>in</strong> <strong>the</strong> secondary c<strong>are</strong> sett<strong>in</strong>g.<br />
Women with type 2 diabetes <strong>we</strong>re less likely to receive postnatal contraceptive advice. It is recognised that<br />
health professionals may fi nd it diffi cult to provide contraceptive advice to women from different cultural<br />
backgrounds due to language diffi culties and perceived cultural sensitivities. Ho<strong>we</strong>ver, this is a vital aspect<br />
of post-delivery counsell<strong>in</strong>g, and every effort should be made by health professionals to help women with<br />
diabetes, <strong>in</strong>clud<strong>in</strong>g those with type 2 diabetes, to prep<strong>are</strong> adequately for future pregnancies.<br />
79
A comparison of type 1 and type 2 diabetes<br />
11.10 Recommendations<br />
Cl<strong>in</strong>ical<br />
1. Dur<strong>in</strong>g <strong>pregnancy</strong>, ret<strong>in</strong>al and renal screen<strong>in</strong>g schedules should be provided for both women with<br />
type 1 and women with type 2 diabetes.<br />
2. Advice about hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong>, <strong>in</strong>clud<strong>in</strong>g prevention and management strategies,<br />
should be provided to both women with type 1 diabetes and women with type 2 diabetes.<br />
Audit and research<br />
3. <strong>Diabetes</strong> networks should audit standards of preconception and <strong>pregnancy</strong> c<strong>are</strong> for both women<br />
with type 1 and women with type 2 diabetes.<br />
References<br />
1. Lusignan S, Sismanidis C, C<strong>are</strong>y IM, DeWilde S, Richards N, Cook DG. Trends <strong>in</strong> <strong>the</strong> prevalence<br />
and management of diagnosed type 2 diabetes 1994-2001 <strong>in</strong> England and Wales. BMC Family<br />
Practice 6(1), 2 Mar 2005: 13.<br />
2. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Pregnancy <strong>in</strong> women with type 1 and<br />
type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
3. Sheth BP. Does <strong>pregnancy</strong> accelerate <strong>the</strong> rate of progression of diabetic ret<strong>in</strong>opathy? Current<br />
<strong>Diabetes</strong> Reports 2(4), Aug 2002: 327-30.<br />
4. Temple RC, Aldridge VA, Sampson MJ, Greenwood RH, Heyburn PJ, Glenn A. Impact of <strong>pregnancy</strong><br />
on <strong>the</strong> progression of diabetic ret<strong>in</strong>opathy <strong>in</strong> Type 1 diabetes. Diabetic Medic<strong>in</strong>e. Jul 2001:<br />
18(7): 573-7.<br />
5. ter Braak EW, Evers IM, Erkelens DW, Visser GH.Maternal hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong><br />
<strong>in</strong> type 1 diabetes: maternal and fetal consequences. <strong>Diabetes</strong> Metab Res Rev 2002; 18:96-105.<br />
6. Dex S, Hea<strong>the</strong>r J (eds). Millennium Cohort Study First Survey: a user’s guide to <strong>in</strong>itial fi nd<strong>in</strong>gs.<br />
Centre for Longitud<strong>in</strong>al Studies: London; 2004.<br />
Commentary<br />
Robert Fraser<br />
Chair, NICE <strong>Diabetes</strong> <strong>in</strong> Pregnancy Guidel<strong>in</strong>e Development Group<br />
Consultant Obstetrician, Royal Hallamshire Hospital, Sheffi eld<br />
The proportionate distribution of type 1 and type 2 diabetes <strong>in</strong> women with diabetes dur<strong>in</strong>g <strong>pregnancy</strong> is<br />
chang<strong>in</strong>g, with an <strong>in</strong>creas<strong>in</strong>g number of pregnancies <strong>in</strong> women with type 2 diabetes be<strong>in</strong>g seen. This is<br />
due to a rapid <strong>in</strong>crease <strong>in</strong> <strong>the</strong> prevalence of obesity <strong>in</strong> all ethnic groups <strong>in</strong> <strong>the</strong> population, obesity occurr<strong>in</strong>g<br />
<strong>in</strong> younger people, and a rise <strong>in</strong> age specifi c maximum fertility. The importance of mature onset diabetes<br />
of youth (MODY) is also becom<strong>in</strong>g recognised amongst younger women with type 2 diabetes and this<br />
group br<strong>in</strong>g <strong>the</strong>ir own particular problems to <strong>pregnancy</strong> management which deserve separate and detailed<br />
management guidel<strong>in</strong>es.<br />
80
Type 1 and type 2 diabetes have traditionally been managed differently. As <strong>the</strong> prevalence of type 2<br />
diabetes <strong>in</strong> <strong>pregnancy</strong> <strong>in</strong>creases, it is appropriate to review how <strong>we</strong> manage women of childbear<strong>in</strong>g age<br />
with known type 2 diabetes. Also, women with gestational diabetes (GDM) <strong>are</strong> at <strong>in</strong>creased risk of type<br />
2 diabetes after <strong>pregnancy</strong>, and <strong>in</strong> some populations up to 20% of women diagnosed to have gestational<br />
diabetes actually have previously undiagnosed type 2 diabetes. This br<strong>in</strong>gs <strong>the</strong>m <strong>in</strong>to a high risk group for<br />
future pregnancies, and although this report did not address gestational diabetes, <strong>the</strong>se women may also<br />
benefi t from properly structured management strategies <strong>in</strong>clud<strong>in</strong>g pre-<strong>pregnancy</strong> c<strong>are</strong>.<br />
Although ret<strong>in</strong>opathy is much less common <strong>in</strong> women with type 2 diabetes it is present <strong>in</strong> a signifi cant<br />
m<strong>in</strong>ority and <strong>the</strong>y <strong>are</strong> presumably equally vulnerable to deterioration of ret<strong>in</strong>opathy dur<strong>in</strong>g <strong>pregnancy</strong>. They<br />
<strong>the</strong>refore need to be enrolled <strong>in</strong> a suitable annual review outside <strong>pregnancy</strong>, ei<strong>the</strong>r <strong>in</strong> primary or secondary<br />
c<strong>are</strong>. They <strong>are</strong> likely to benefi t as much as women with type 1 diabetes from digital ret<strong>in</strong>al photography.<br />
In <strong>the</strong> CEMACH enquiry, unplanned <strong>pregnancy</strong> and preconception folic acid use was equivalent <strong>in</strong> women<br />
with type 1 and type 2 diabetes, and women with type 2 diabetes appe<strong>are</strong>d less likely to use contraception.<br />
It is important that both groups of women should have messages re<strong>in</strong>forced about <strong>pregnancy</strong> preparation.<br />
Dur<strong>in</strong>g <strong>pregnancy</strong>, it is clear that women with type 2 diabetes should have <strong>the</strong> same standard of maternal<br />
and fetal surveillance as women with type 1 diabetes. Ho<strong>we</strong>ver, women with type 2 diabetes have a<br />
relative rarity of severe hypoglycaemia requir<strong>in</strong>g third party assistance.<br />
Dur<strong>in</strong>g labour, fe<strong>we</strong>r women with type 2 diabetes receive <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose; this is perhaps<br />
a refl ection of reasonable cl<strong>in</strong>ical practice <strong>in</strong> that <strong>the</strong>se women may very <strong>we</strong>ll have shorter labours and <strong>are</strong><br />
certa<strong>in</strong>ly at less risk of serious metabolic disturbance dur<strong>in</strong>g labour.<br />
The fi nd<strong>in</strong>g that women with type 2 diabetes <strong>are</strong> less likely to receive postnatal contraceptive advice is<br />
of concern, and <strong>the</strong> importance of provid<strong>in</strong>g contraceptive advice to this particular group of women must<br />
be emphasised through adult diabetes services and general practitioners. It may also be worthwhile to<br />
extend education about <strong>the</strong> <strong>pregnancy</strong> risks for women with type 2 diabetes to o<strong>the</strong>r primary c<strong>are</strong> health<br />
professionals such as Family Plann<strong>in</strong>g practitioners and nurses.<br />
81
12. Neonatal c<strong>are</strong> of term babies<br />
Learn<strong>in</strong>g po<strong>in</strong>ts<br />
• One third of admissions to a neonatal unit occurred because of a unit policy of rout<strong>in</strong>ely<br />
admitt<strong>in</strong>g <strong>we</strong>ll babies of mo<strong>the</strong>rs with diabetes. Enquiry panels assessed that over half of all<br />
neonatal admissions <strong>we</strong>re avoidable.<br />
• Several barriers to breastfeed<strong>in</strong>g <strong>we</strong>re reported:<br />
- Lack of early close maternal contact and early feed<strong>in</strong>g on <strong>the</strong> labour ward<br />
- High rate of <strong>in</strong>fant formula given as fi rst feed<br />
- Infant formula given to all babies admitted to a neonatal unit, even when <strong>the</strong><br />
maternal <strong>in</strong>tention was to breastfeed<br />
- Infant formula feed<strong>in</strong>g on <strong>the</strong> postnatal ward often expla<strong>in</strong>ed by maternal choice.<br />
• Blood glucose test<strong>in</strong>g often took place too early with <strong>in</strong>appropriate methods of test<strong>in</strong>g used;<br />
documentation of blood glucose tests was poor.<br />
• Two thirds of babies <strong>we</strong>re assessed to have suboptimal neonatal c<strong>are</strong> on <strong>the</strong> delivery suite;<br />
this frequently affected subsequent c<strong>are</strong>.<br />
• A quarter of medical records did not have a written management plan.<br />
12.1 Introduction<br />
In 2002, 30% of hospitals <strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland reported that <strong>the</strong>y rout<strong>in</strong>ely admitted<br />
babies of women with diabetes to a neonatal unit. 1 In addition, <strong>the</strong> CEMACH descriptive study of 3808<br />
pregnancies to women with type 1 and type 2 diabetes found substandard neonatal management of<br />
hypoglycaemia and early feed<strong>in</strong>g; a lo<strong>we</strong>r <strong>in</strong>tention to breastfeed <strong>in</strong> mo<strong>the</strong>rs with diabetes at birth than <strong>in</strong><br />
<strong>the</strong> general population; and a higher number than expected admissions of term babies to a neonatal unit. 2<br />
It was <strong>the</strong>refore decided to carry out an additional enquiry <strong>in</strong>to <strong>the</strong> neonatal c<strong>are</strong> of term babies of women<br />
with diabetes <strong>in</strong> <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme. The key fi nd<strong>in</strong>gs <strong>are</strong> summarised <strong>in</strong> this chapter.<br />
12.2 Methodology<br />
12.2.1 Composition and location of enquiry panels<br />
Enquiry panel meet<strong>in</strong>gs <strong>we</strong>re held <strong>in</strong> fi ve CEMACH regions (East of England, London, North East, North<br />
West and South West) bet<strong>we</strong>en January and April 2006. Each panel consisted of two representatives from<br />
each of <strong>the</strong> follow<strong>in</strong>g discipl<strong>in</strong>es:<br />
• Neonatologists<br />
• Neonatal nurses<br />
• Midwives.<br />
82
Panels <strong>we</strong>re chaired by <strong>the</strong> panel chairs appo<strong>in</strong>ted for <strong>the</strong> <strong>Diabetes</strong> Enquiry or by <strong>the</strong> CEMACH regional<br />
manager of that region. Six cases <strong>we</strong>re revie<strong>we</strong>d at each meet<strong>in</strong>g. Cases revie<strong>we</strong>d <strong>we</strong>re selected from<br />
a national pool exclud<strong>in</strong>g <strong>the</strong> region of <strong>the</strong> assess<strong>in</strong>g panel, to ensure an <strong>in</strong>dependent assessment of <strong>the</strong><br />
c<strong>are</strong> provided. Each panel was provided with neonatal records and charts perta<strong>in</strong><strong>in</strong>g to <strong>the</strong> fi rst three days<br />
after delivery, discharge summaries, <strong>the</strong> postnatal maternity notes, any relevant correspondence<br />
and hospital protocols.<br />
12.2.2 Enquiry pro forma<br />
Cl<strong>in</strong>ical guidance for <strong>the</strong> neonatal enquiry was provided by a steer<strong>in</strong>g group of cl<strong>in</strong>icians with specifi c<br />
experience <strong>in</strong> neonatal c<strong>are</strong> for babies of women with diabetes (Appendix F). A structured enquiry pro<br />
forma (accessible at www.cemach.org.uk) was developed <strong>in</strong> consultation with members of <strong>the</strong> steer<strong>in</strong>g<br />
group. This pro forma was designed to assess neonatal c<strong>are</strong> provided on <strong>the</strong> labour ward, <strong>the</strong> postnatal<br />
ward or on <strong>the</strong> neonatal unit.<br />
12.2.3 Standards of c<strong>are</strong><br />
C<strong>are</strong> was assessed aga<strong>in</strong>st standards relat<strong>in</strong>g to <strong>the</strong> location of c<strong>are</strong>, blood glucose monitor<strong>in</strong>g,<br />
temperature management and feed<strong>in</strong>g. The cl<strong>in</strong>ical standards for this enquiry <strong>we</strong>re those used <strong>in</strong> <strong>the</strong><br />
CEMACH <strong>Diabetes</strong> Programme (accessible at www.cemach.org.uk), with some additional standards<br />
from <strong>the</strong> Baby Friendly Initiative. 3<br />
12.2.4 Enquiry sample<br />
In <strong>the</strong> neonatal enquiry, pregnancies <strong>we</strong>re randomly sampled from <strong>the</strong> diabetes cohort database of 3808<br />
pregnancies after exclud<strong>in</strong>g deaths, fetal congenital anomalies, multiple births and gestation at delivery<br />
less than 37+0 <strong>we</strong>eks. The case defi nition for <strong>the</strong> neonatal enquiry was <strong>the</strong>refore all term pregnancies <strong>in</strong><br />
women with diabetes result<strong>in</strong>g <strong>in</strong> a normally formed baby surviv<strong>in</strong>g to 28 days after delivery. One hundred<br />
and thirty two babies met this case defi nition. Neonatal medical records <strong>we</strong>re not available for 13 babies,<br />
leav<strong>in</strong>g 119 babies for enquiry. These babies <strong>we</strong>re <strong>the</strong>n divided <strong>in</strong>to two groups for fur<strong>the</strong>r comparative<br />
analysis:<br />
• babies who <strong>we</strong>re <strong>in</strong>itially admitted with <strong>the</strong>ir mo<strong>the</strong>r to <strong>the</strong> postnatal ward or to a transitional c<strong>are</strong><br />
unit a , or who stayed with <strong>the</strong>ir mo<strong>the</strong>r on <strong>the</strong> labour ward or a maternal high dependency unit<br />
• babies who <strong>we</strong>re <strong>in</strong>itially admitted to a neonatal unit for special c<strong>are</strong>. b<br />
a<br />
defi ned as units where, if baby needs non <strong>in</strong>tensive treatment and monitor<strong>in</strong>g, mo<strong>the</strong>rs and babies can be c<strong>are</strong>d for toge<strong>the</strong>r under<br />
supervision of neonatal staff.<br />
b<br />
C<strong>are</strong> provided for all babies not receiv<strong>in</strong>g <strong>in</strong>tensive or high dependency c<strong>are</strong> but whose c<strong>are</strong>rs could not reasonably be expected to<br />
look after <strong>the</strong>m <strong>in</strong> hospital or at home (British Association of Per<strong>in</strong>atal Medic<strong>in</strong>e 2001).<br />
83
Neonatal c<strong>are</strong> of term babies<br />
12.3 The babies <strong>in</strong> <strong>the</strong> neonatal enquiry<br />
In <strong>the</strong> 119 babies selected for neonatal enquiry, two sets of medical records <strong>we</strong>re not available and fi ve<br />
babies had no documented location of c<strong>are</strong>. Amongst <strong>the</strong> rema<strong>in</strong><strong>in</strong>g 112 babies with data available on <strong>the</strong>ir<br />
c<strong>are</strong> <strong>in</strong> <strong>the</strong> fi rst three days of life, 70 babies <strong>we</strong>re nursed <strong>in</strong>itially with <strong>the</strong>ir mo<strong>the</strong>rs (61 on <strong>the</strong> postnatal<br />
ward, fi ve <strong>in</strong> a transitional c<strong>are</strong> unit and four on <strong>the</strong> labour ward or maternal high dependency unit). By<br />
day three, nearly half of <strong>the</strong>se 70 babies had been discharged from hospital. Six babies, who <strong>we</strong>re <strong>in</strong>itially<br />
nursed with <strong>the</strong>ir mo<strong>the</strong>r, <strong>we</strong>re later admitted to a neonatal unit.<br />
Forty two babies <strong>we</strong>re admitted directly to a neonatal unit after delivery. By day three, one third of <strong>the</strong>se<br />
42 babies <strong>we</strong>re still on <strong>the</strong> unit while two thirds had returned to be with <strong>the</strong>ir mo<strong>the</strong>rs on <strong>the</strong> postnatal ward.<br />
Two babies <strong>we</strong>re later readmitted to <strong>the</strong> neonatal unit.<br />
12.4 Avoidable admissions<br />
Current national guidance is that babies of women with diabetes should be admitted to a neonatal unit only<br />
if <strong>the</strong>re is a specifi c medical <strong>in</strong>dication. 5-7 As already mentioned, <strong>in</strong> 2002, a third of units rout<strong>in</strong>ely admitted<br />
babies of women with diabetes to <strong>the</strong> neonatal unit. 1 The CEMACH descriptive study also found that<br />
30% of term babies <strong>we</strong>re admitted to a neonatal unit 2 , a threefold <strong>in</strong>crease over <strong>the</strong> neonatal admission<br />
rate <strong>in</strong> <strong>the</strong> general maternity population <strong>in</strong> <strong>the</strong> UK. 4 This is concern<strong>in</strong>g, as separation of mo<strong>the</strong>r and baby<br />
after birth may affect a number of important processes such as early establishment of breastfeed<strong>in</strong>g,<br />
temperature control and emotional bond<strong>in</strong>g.<br />
12.4.1 Enquiry fi nd<strong>in</strong>gs<br />
The three ma<strong>in</strong> <strong>in</strong>dications for admission to a neonatal unit <strong>we</strong>re a hospital policy of rout<strong>in</strong>e admission of<br />
healthy babies of mo<strong>the</strong>rs with diabetes; non-symptomatic hypoglycaemia <strong>in</strong> a healthy baby; and a cl<strong>in</strong>ical<br />
need for admission such as poor feed<strong>in</strong>g and respiratory problems.<br />
Table 12.1<br />
Reasons for admission of babies of mo<strong>the</strong>rs with diabetes to a neonatal unit<br />
Babies admitted to a neonatal unit<br />
n (%)<br />
(N=42)<br />
Hospital policy (<strong>in</strong>fant of mo<strong>the</strong>r with diabetes) 12 (29)<br />
Non symptomatic hypoglycaemia <strong>in</strong> a <strong>we</strong>ll baby 11 (26)<br />
Baby cl<strong>in</strong>ically need<strong>in</strong>g admission: 18 (43)<br />
Hypo<strong>the</strong>rmia (with hypoglycaemia) 6<br />
Poor feed<strong>in</strong>g (with hypoglycaemia) 3<br />
Macrosomia (o<strong>the</strong>rwise <strong>we</strong>ll baby) 3<br />
Respiratory diffi culties 5<br />
O<strong>the</strong>r medical condition (cardiac) 1<br />
Not known 1 (0)<br />
84
In 57% (24/42) of cases, a junior doctor (senior house offi cer <strong>in</strong> paediatrics) made <strong>the</strong> decision to admit<br />
a baby to <strong>the</strong> neonatal unit. Enquiry panels assessed that 57% (24/42) of admissions could have been<br />
avoided, with subsequent c<strong>are</strong> be<strong>in</strong>g adversely affected for 63% (15/24) of <strong>the</strong> babies. The ma<strong>in</strong> <strong>are</strong>a<br />
of c<strong>are</strong> affected by an avoidable admission was feed<strong>in</strong>g, for 50% (12/24) of <strong>the</strong> babies.<br />
12.4.2 Panel comments on avoidable admissions<br />
Enquiry panels made 24 comments for 24 babies about avoidable admissions. The most frequent<br />
comment, for 63% (15/24) of babies, was that <strong>the</strong>re was no valid medical reason to admit to <strong>the</strong> neonatal<br />
unit (table 12.2).<br />
Table 12.2<br />
Panel comments on avoidable admissions to a neonatal unit (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation<br />
of free text)<br />
No. of<br />
comments<br />
Total comments 24<br />
% of avoidable admissions<br />
(N=24)<br />
No medical reason for admission 15 63<br />
Poor management of temperature 5 21<br />
Delay <strong>in</strong> <strong>in</strong>itiat<strong>in</strong>g feed<strong>in</strong>g 2 8<br />
Poor maternal blood glucose management dur<strong>in</strong>g labour/at<br />
1 4<br />
delivery<br />
Blood glucose tested too soon after delivery 1 4<br />
12.5 Barriers to breastfeed<strong>in</strong>g<br />
Several studies have shown that postnatal c<strong>are</strong> programmes such as <strong>the</strong> Baby Friendly <strong>in</strong>itiative that help<br />
promote undisturbed mo<strong>the</strong>r-<strong>in</strong>fant contact improve breastfeed<strong>in</strong>g success. 3,8,9 These <strong>in</strong>itiatives <strong>are</strong> likely<br />
to be of benefi t to mo<strong>the</strong>rs with diabetes and <strong>the</strong>ir babies, who may be more vulnerable to <strong>the</strong> negative<br />
psychological impact of a high-risk medical condition <strong>in</strong> <strong>pregnancy</strong>. 10 There is evidence that babies whose<br />
mo<strong>the</strong>rs keep <strong>the</strong>m <strong>in</strong> closer sk<strong>in</strong> contact <strong>are</strong> warm, calm and reassured. 11,12 Systematic reviews of early<br />
sk<strong>in</strong> contact bet<strong>we</strong>en mo<strong>the</strong>rs and babies also show benefi ts <strong>in</strong> relation to breastfeed<strong>in</strong>g and <strong>in</strong>fant<br />
cry<strong>in</strong>g. 13<br />
National guidance for women with diabetes recommends breastfeed<strong>in</strong>g as early as possible after<br />
delivery, 6,7 as <strong>the</strong>se babies may be at risk of hypoglycaemia. 5,14 In addition, <strong>in</strong>fant formula supplementation<br />
may suppress <strong>the</strong> process of normal metabolic adaptation. Breast milk is thought to promote ketogenesis 15<br />
and should <strong>the</strong>refore be <strong>the</strong> fi rst choice for babies of women with diabetes, as <strong>the</strong>y <strong>are</strong> at risk of<br />
hypoketonaemic hypoglycaemia. Ho<strong>we</strong>ver, <strong>the</strong> previous CEMACH descriptive study found that <strong>the</strong><br />
<strong>in</strong>tention to breastfeed rate <strong>in</strong> women with diabetes was lo<strong>we</strong>r than <strong>the</strong> <strong>in</strong>itial breastfeed<strong>in</strong>g rate <strong>in</strong> <strong>the</strong><br />
general population. 2,16<br />
85
Neonatal c<strong>are</strong> of term babies<br />
12.5.1 Enquiry fi nd<strong>in</strong>gs<br />
Early feed<strong>in</strong>g and sk<strong>in</strong>-to-sk<strong>in</strong> contact on <strong>the</strong> labour ward<br />
Opportunity for early sk<strong>in</strong>-to-sk<strong>in</strong> contact after birth (with<strong>in</strong> 30 m<strong>in</strong>utes of delivery, or as soon as <strong>the</strong> mo<strong>the</strong>r<br />
was able to respond follow<strong>in</strong>g caes<strong>are</strong>an section) was documented to be achieved for 29% (30/102) of<br />
babies. In eight <strong>in</strong>stances, sk<strong>in</strong>-to-sk<strong>in</strong> contact was considered not practicable because of <strong>the</strong> cl<strong>in</strong>ical<br />
condition of mo<strong>the</strong>r and/or <strong>the</strong> baby.<br />
Seventy seven percent (75/97) of babies received <strong>the</strong>ir fi rst feed while on <strong>the</strong> labour ward. N<strong>in</strong>ety fi ve<br />
percent of babies rema<strong>in</strong><strong>in</strong>g with <strong>the</strong>ir mo<strong>the</strong>rs received <strong>the</strong>ir fi rst feed on <strong>the</strong> labour ward comp<strong>are</strong>d to<br />
50% of babies admitted to a neonatal unit (p
Infant formula given as fi rst feed<br />
Infant formula was <strong>the</strong> most frequently recorded milk given at fi rst feed (for 63%, 67/106 of babies <strong>in</strong> <strong>the</strong><br />
enquiry) (table 12.4). T<strong>we</strong>nty n<strong>in</strong>e percent of <strong>the</strong> 31 formula-fed babies admitted to a neonatal unit <strong>we</strong>re<br />
fed ei<strong>the</strong>r by a cup or by tube, but a bottle was used to give <strong>the</strong> fi rst feed for all 36 formula-fed babies who<br />
rema<strong>in</strong>ed with <strong>the</strong>ir mo<strong>the</strong>rs. Breast milk was <strong>the</strong> fi rst feed for 40% of 106 babies (50%, 34/68 of babies<br />
who rema<strong>in</strong>ed with <strong>the</strong>ir mo<strong>the</strong>rs and 21%, 8/38 of babies admitted to a neonatal unit, p=0.001).<br />
The most frequent reason documented for <strong>in</strong>fant formula be<strong>in</strong>g given at any feed to babies rema<strong>in</strong><strong>in</strong>g with<br />
<strong>the</strong>ir mo<strong>the</strong>rs, was maternal choice, for 46% (32/70) of babies.<br />
Table 12.4<br />
Type of milk at fi rst feed for babies of women with type 1 and type 2 diabetes<br />
Babies rema<strong>in</strong><strong>in</strong>g with mo<strong>the</strong>r<br />
n(%)<br />
(N=70*)<br />
Babies admitted to NNU<br />
n(%)<br />
(N=42*)<br />
Total<br />
n(%)<br />
(N=112)<br />
Maternal breast milk 34 (50) 8 (21) 42 (40)<br />
Donor breast milk 2 (3) 0 (0) 2 (2)<br />
Infant formula 36 (53) 31 (82) 67 (63)<br />
Type of milk at fi rst feed<br />
not recorded 2 4 6<br />
* some babies had more than one option for fi rst feed ticked.<br />
Intention to breastfeed<br />
The fi rst feed given was not <strong>the</strong> mo<strong>the</strong>rs’ <strong>in</strong>tended type of feed for 28% (27/96) of babies (16% of babies<br />
who rema<strong>in</strong>ed with <strong>the</strong>ir mo<strong>the</strong>rs and 50% of those admitted to a neonatal unit, p
Neonatal c<strong>are</strong> of term babies<br />
12.5.2 Panel assessment of feed<strong>in</strong>g <strong>in</strong> <strong>the</strong> neonatal unit<br />
Panels assessed that <strong>the</strong> type of feed <strong>the</strong> baby received was appropriate <strong>in</strong> 62% (26/42) of cases.<br />
12.5.3 Panel assessment of <strong>the</strong> impact of management <strong>in</strong> <strong>the</strong> neonatal c<strong>are</strong> unit on feed<strong>in</strong>g<br />
Panels considered that management of <strong>the</strong> baby, over and above <strong>the</strong> fact of be<strong>in</strong>g on <strong>the</strong> neonatal unit<br />
for special c<strong>are</strong>, was likely to have had a negative impact on <strong>the</strong> establishment of feed<strong>in</strong>g for 38% (15/40)<br />
of all babies (46%, 11/24 when <strong>the</strong>re was a maternal <strong>in</strong>tention to breastfeed and 25%, 4/16 when an<br />
alternative method of feed<strong>in</strong>g was <strong>in</strong>tended (p=0.18) (table 12.6).<br />
Table 12.6<br />
Panel assessment of <strong>the</strong> impact of management of <strong>the</strong> baby on establishment of feed<strong>in</strong>g for babies of women with<br />
type 1 and type 2 diabetes on <strong>the</strong> neonatal unit<br />
Maternal <strong>in</strong>tention to breastfeed<br />
Effect of management of <strong>the</strong> baby<br />
Yes<br />
n(%)<br />
(N=25)<br />
No<br />
n(%)<br />
(N=17)<br />
Total<br />
n(%)*<br />
(N=42)<br />
Had an impact on establishment of feed<strong>in</strong>g 11 (46) 4 (25) 15 (38)<br />
Did not have an impact on establishment of feee<strong>in</strong>g 12 (50) 10 (63) 22 (55)<br />
Not enough <strong>in</strong>formation 1 (4) 2 (13) 3 (8)<br />
Miss<strong>in</strong>g 1 1 2<br />
* Percentages <strong>are</strong> calculated from all babies <strong>in</strong> relevant category exclud<strong>in</strong>g those babies where data was miss<strong>in</strong>g.<br />
12.6 Blood glucose management<br />
The standard agreed for <strong>the</strong> CEMACH <strong>Diabetes</strong> Programme (standards accessible at www.cemach.org.uk)<br />
stated that babies of mo<strong>the</strong>rs with diabetes should have a test of blood glucose concentration by 4-6 hours<br />
of age, before a feed. 2 The previous descriptive study suggested that blood glucose test<strong>in</strong>g was often<br />
performed too soon, co<strong>in</strong>cid<strong>in</strong>g with <strong>the</strong> physiological fall <strong>in</strong> blood glucose after birth and potentially lead<strong>in</strong>g<br />
to unnecessary admissions to <strong>the</strong> neonatal unit. 2<br />
The descriptive study also found that neonatal blood glucose test<strong>in</strong>g was ma<strong>in</strong>ly carried out us<strong>in</strong>g a<br />
reagent strip technique. 2 Reagent strip test<strong>in</strong>g is unreliable 17 and when consider<strong>in</strong>g <strong>the</strong> diagnosis of<br />
hypoglycaemia, at least one laboratory value should be obta<strong>in</strong>ed. 18 The suitability of us<strong>in</strong>g a portable<br />
glucose photometer such as <strong>the</strong> HaemoCue to diagnose neonatal hypoglycaemia is not universally<br />
accepted. 17, 19-21 Currently, national guidel<strong>in</strong>es recommend that <strong>the</strong> diagnosis of neonatal hypoglycaemia <strong>in</strong><br />
babies at <strong>in</strong>creased risk should be made us<strong>in</strong>g ward-based glucose electrode or laboratory methods and<br />
not by reagent strip. 2,6<br />
12.6.1 Enquiry fi nd<strong>in</strong>gs<br />
12.6.1.1 Tim<strong>in</strong>g of first blood glucose test<strong>in</strong>g<br />
Babies had <strong>the</strong>ir fi rst blood glucose test ma<strong>in</strong>ly dur<strong>in</strong>g <strong>the</strong> fi rst two hours of life (table 12.7 ). The fi rst<br />
test was performed at a median of 1.15 hours <strong>in</strong> babies admitted to a neonatal unit and at a median of<br />
88
2.1 hours <strong>in</strong> babies rema<strong>in</strong><strong>in</strong>g with <strong>the</strong>ir mo<strong>the</strong>rs. The wide range <strong>in</strong> age of <strong>the</strong> baby at fi rst blood glucose<br />
test shows that some tests <strong>we</strong>re carried out almost immediately after birth. Median fi rst blood glucose<br />
values <strong>we</strong>re identical <strong>in</strong> both groups. Panels <strong>we</strong>re asked if <strong>the</strong>re <strong>we</strong>re abnormal cl<strong>in</strong>ical signs attributable<br />
to hypoglycaemia at <strong>the</strong> time of <strong>the</strong> fi rst blood glucose measurement: two babies <strong>we</strong>re described as jittery<br />
with no o<strong>the</strong>r symptoms.<br />
Table 12.7<br />
Tim<strong>in</strong>g and result of fi rst blood glucose measurement <strong>in</strong> term babies of women with type 1 and type 2 diabetes<br />
Time of fi rst blood glucose<br />
measurement (hours)<br />
(median [IQR] (range)<br />
First blood glucose value<br />
(mmol/L) (median [IQR]<br />
(range)<br />
Babies rema<strong>in</strong><strong>in</strong>g with mo<strong>the</strong>r<br />
(N=70)<br />
2.1 [0.97-433]<br />
(0.05 - 9.63)<br />
2.8 [2.3-3.7]<br />
(0.8 - 9.0)<br />
Babies admitted to NNU<br />
(N=42)<br />
N=58 1.15 [0.38-1.97]<br />
(0 - 7.6)<br />
N=68 2.5 [2.0-3.3]<br />
(0.8 - 5.7)<br />
p-value<br />
n=34 0.08<br />
n=39 0.42<br />
12.6.1.2 Methods of blood glucose test<strong>in</strong>g<br />
Reagent strip test<strong>in</strong>g was <strong>the</strong> ma<strong>in</strong> method documented. In many cases, <strong>the</strong>re was no documentation of<br />
<strong>the</strong> method used (table 12.8). It was also noted that <strong>the</strong> abbreviation “BM” was often used <strong>in</strong>appropriately<br />
to denote blood glucose.<br />
Table 12.8<br />
Method used for fi rst blood glucose measurement <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Method used<br />
Babies <strong>in</strong> neonatal enquiry<br />
(N=112)<br />
HaemoCue 10<br />
Reagent strip 53<br />
Dextrostix 0<br />
“BM” 53<br />
Glucose electrode method 6<br />
Yellow spr<strong>in</strong>gs 0<br />
Blood gas analyser 4<br />
O<strong>the</strong>r glucose electrode method 2<br />
O<strong>the</strong>r 1<br />
Not documented 42<br />
Sixty eight percent of blood glucose measurement tests <strong>we</strong>re done pre-feed and 26% post-feed (table<br />
12.9). These proportions <strong>we</strong>re similar for babies admitted to a neonatal unit and babies rema<strong>in</strong><strong>in</strong>g<br />
with <strong>the</strong>ir mo<strong>the</strong>rs.<br />
89
Neonatal c<strong>are</strong> of term babies<br />
Table 12.9<br />
Tim<strong>in</strong>g of fi rst blood glucose measurement <strong>in</strong> relation to feed <strong>in</strong> babies of mo<strong>the</strong>rs with type 1 and type 2 diabetes<br />
Tim<strong>in</strong>g of first blood glucose<br />
measurement<br />
Babies rema<strong>in</strong><strong>in</strong>g with<br />
mo<strong>the</strong>r<br />
n(%)<br />
(N=70)<br />
Babies admitted to NNU<br />
n(%)<br />
(N=42)<br />
Total<br />
(N=112)<br />
Pre-feed 43 (64) 28 (74) 71 (68)<br />
Post-feed 18 (27) 9 (24) 27 (26)<br />
Random 6 (9) 1 (3) 7 (7)<br />
Miss<strong>in</strong>g 3 4 7<br />
12.6.2 Panel assessment of documentation of blood glucose management<br />
Panels assessed that documentation of blood glucose measurements was more frequently suboptimal<br />
on <strong>the</strong> postnatal ward (81%, 57/70 of babies) than on <strong>the</strong> neonatal unit (48%, 20/42 of babies, p
12.7.1 Panel comments on suboptimal c<strong>are</strong> of babies on <strong>the</strong> labour ward<br />
Panels made 95 comments for <strong>the</strong> 62 babies whose c<strong>are</strong> on <strong>the</strong> labour ward was suboptimal (table 12.11).<br />
The most frequently recorded issues <strong>we</strong>re: a) <strong>in</strong>appropriate tim<strong>in</strong>g of blood glucose test<strong>in</strong>g b) no close<br />
early contact bet<strong>we</strong>en mo<strong>the</strong>r and baby/ missed breastfeed<strong>in</strong>g opportunities c) allow<strong>in</strong>g <strong>the</strong> baby to get<br />
cold and d) no plan of c<strong>are</strong>.<br />
Table 12.11<br />
Panel comments on suboptimal c<strong>are</strong> on <strong>the</strong> labour ward (table conta<strong>in</strong>s <strong>in</strong>formation follow<strong>in</strong>g categorisation of free<br />
text)<br />
Babies with suboptimal c<strong>are</strong> on labour<br />
ward<br />
(N=62)<br />
No. of comments % of babies<br />
Total comments 95<br />
Blood glucose 22 36<br />
Done too soon 7<br />
Delayed 5<br />
No monitor<strong>in</strong>g 2<br />
Substandard management 7<br />
No documentation 1<br />
Feed<strong>in</strong>g 23 37<br />
Delayed 7<br />
No sk<strong>in</strong>-to-sk<strong>in</strong> contact/breastfeed<strong>in</strong>g opportunity 12<br />
Breastfeed<strong>in</strong>g impaired/overturned 2<br />
O<strong>the</strong>r management 1<br />
No documentation 1<br />
Temperature 29 47<br />
Allo<strong>we</strong>d to get cold 12<br />
No monitor<strong>in</strong>g 9<br />
Not documented 8<br />
Overall management 16 26<br />
No cl<strong>in</strong>ical assessment 2<br />
No plan of c<strong>are</strong> 12<br />
No guidel<strong>in</strong>es/protocol 2<br />
O<strong>the</strong>r 5 8<br />
12.8 Written management plans<br />
It is important to have a clear written management plan at birth for babies of women with diabetes, to help<br />
staff on <strong>the</strong> neonatal unit and midwives on <strong>the</strong> postnatal ward to direct <strong>the</strong>ir neonatal c<strong>are</strong> appropriately.<br />
91
Neonatal c<strong>are</strong> of term babies<br />
12.8.1 Enquiry fi nd<strong>in</strong>gs<br />
There was evidence of a clear written c<strong>are</strong> plan for 73% (51/70) of babies who rema<strong>in</strong>ed with <strong>the</strong>ir mo<strong>the</strong>rs<br />
and 57% (24/42) of babies admitted to a neonatal unit (table 12.12). The plan referred to a hospital<br />
protocol <strong>in</strong> a third or less of <strong>the</strong> cases, and <strong>in</strong>cluded advice about blood glucose monitor<strong>in</strong>g and feed<strong>in</strong>g<br />
more consistently than for o<strong>the</strong>r <strong>are</strong>as of c<strong>are</strong>. A temperature management plan was present <strong>in</strong> less than<br />
half of babies, and <strong>the</strong> recommended location of c<strong>are</strong> was documented for a third of babies rema<strong>in</strong><strong>in</strong>g<br />
with <strong>the</strong>ir mo<strong>the</strong>rs and two thirds of babies admitted to a neonatal unit. The c<strong>are</strong> plan was written by <strong>the</strong><br />
paediatric Senior House Offi cer for 57% (42/74) of babies and by <strong>the</strong> midwife for 15% (11/74) of babies. In<br />
22% of cases, <strong>the</strong>re was <strong>in</strong>suffi cient <strong>in</strong>formation <strong>in</strong> <strong>the</strong> notes to determ<strong>in</strong>e who had written <strong>the</strong> c<strong>are</strong> plan.<br />
The c<strong>are</strong> plan was not fully follo<strong>we</strong>d for 35% (18/51) of babies rema<strong>in</strong><strong>in</strong>g with <strong>the</strong>ir mo<strong>the</strong>r; aspects of <strong>the</strong><br />
c<strong>are</strong> plan not follo<strong>we</strong>d <strong>in</strong>cluded blood glucose management, feed<strong>in</strong>g and temperature control.<br />
Table 12.12<br />
Written c<strong>are</strong> plan for babies of women with type 1 and type 2 diabetes<br />
Babies rema<strong>in</strong><strong>in</strong>g with mo<strong>the</strong>r<br />
n(%)*<br />
(N=70)<br />
Babies admitted to NNU<br />
n(%)*<br />
(N=42)<br />
p-value<br />
Evidence of a written plan 51 (73) 24 (57) 0.12<br />
Plan refers to hospital protocol 17 (33) 5 (21) 0.27<br />
Location of c<strong>are</strong> 18 (35) 16 (67) 0.01<br />
Blood glucose monitor<strong>in</strong>g 47 (92) 19 (79) 0.16<br />
Temperature management 24 (47) 7 (29) 0.14<br />
Feed<strong>in</strong>g 43 (84) 16 (67) 0.12<br />
* Percentages <strong>are</strong> calculated for each aspect of <strong>the</strong> c<strong>are</strong> plan after exclud<strong>in</strong>g miss<strong>in</strong>g data.<br />
12.9 Conclusions<br />
The overall fi nd<strong>in</strong>gs of this enquiry <strong>in</strong>to <strong>the</strong> neonatal c<strong>are</strong> of term babies born to mo<strong>the</strong>rs with diabetes<br />
suggested that:<br />
• There <strong>we</strong>re many concerns about cl<strong>in</strong>ical c<strong>are</strong> and documentation, especially on <strong>the</strong> labour ward:<br />
• Avoidable admissions had an adverse effect on <strong>the</strong> establishment of breastfeed<strong>in</strong>g<br />
• Initial support for early mo<strong>the</strong>r-baby contact and breastfeed<strong>in</strong>g was <strong>in</strong>consistent<br />
• Tim<strong>in</strong>g and method of blood glucose monitor<strong>in</strong>g was <strong>in</strong>consistent.<br />
• There was little evidence of senior paediatric staff <strong>in</strong>volvement <strong>in</strong> <strong>the</strong> management of this group of<br />
babies.<br />
• Many healthy babies of mo<strong>the</strong>rs with diabetes <strong>we</strong>re separated from <strong>the</strong>ir p<strong>are</strong>nts without a good<br />
medical reason. The design of most maternity units, where neonatal expertise is predom<strong>in</strong>antly<br />
concentrated <strong>in</strong> <strong>the</strong> neonatal unit, may partly expla<strong>in</strong> why trusts <strong>are</strong> reluctant to provide c<strong>are</strong> for<br />
<strong>the</strong>se higher risk babies on a postnatal ward with <strong>the</strong>ir mo<strong>the</strong>rs. Br<strong>in</strong>g<strong>in</strong>g neonatal expertise close to<br />
<strong>the</strong> mo<strong>the</strong>rs as occurs <strong>in</strong> transitional c<strong>are</strong> wards, may be <strong>the</strong> solution.<br />
92
The concerns described here probably extend beyond <strong>the</strong> specifi c group of babies of mo<strong>the</strong>rs with<br />
diabetes. They open a national debate on whe<strong>the</strong>r basic neonatal c<strong>are</strong> can be delivered closer to <strong>the</strong><br />
mo<strong>the</strong>r <strong>in</strong> maternity units <strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland.<br />
Some quotes from <strong>the</strong> panel discussions<br />
• ‘Should not have got cold, should not have gone to <strong>the</strong> neonatal unit, could have ended<br />
up breastfeed<strong>in</strong>g.’<br />
• ‘This was a rout<strong>in</strong>e admission to <strong>the</strong> neonatal unit. Breastfeed<strong>in</strong>g was not <strong>in</strong>itiated and<br />
unnecessary procedures <strong>we</strong>re done.’<br />
• ‘Blood glucose taken too early. This had an effect on c<strong>are</strong> and <strong>the</strong> establishment of breastfeed<strong>in</strong>g.’<br />
• ‘If <strong>the</strong> blood glucose had not been done so soon, mo<strong>the</strong>r and baby may not have needed<br />
to be separated.’<br />
• ‘Mo<strong>the</strong>r wanted to breastfeed, but paediatric SHO overrode this and made <strong>the</strong> feed to be<br />
<strong>in</strong>fant formula.’<br />
• ‘No management plan of c<strong>are</strong> when baby transferred to postnatal ward and baby was left for<br />
eight hours without a feed and not enough true blood glucose results.’<br />
12.10 Recommendations<br />
1. All units deliver<strong>in</strong>g women with diabetes should have a written policy for <strong>the</strong> management of<br />
<strong>the</strong> baby. The policy should assume that babies will rema<strong>in</strong> with <strong>the</strong>ir mo<strong>the</strong>rs <strong>in</strong> <strong>the</strong> absence<br />
of complications.<br />
2. Mo<strong>the</strong>rs with diabetes should be <strong>in</strong>formed antenatally of <strong>the</strong> benefi cial effects of breastfeed<strong>in</strong>g<br />
on metabolic control for both <strong>the</strong>mselves and <strong>the</strong>ir babies.<br />
3. Mo<strong>the</strong>rs with diabetes should be offered an opportunity for sk<strong>in</strong>-to-sk<strong>in</strong> contact with <strong>the</strong>ir babies<br />
immediately after delivery. Breastfeed<strong>in</strong>g with<strong>in</strong> one hour of birth should be encouraged.<br />
4. Blood glucose test<strong>in</strong>g performed too early should be avoided <strong>in</strong> <strong>we</strong>ll babies without signs of<br />
hypoglycaemia. Test<strong>in</strong>g should be performed before a feed us<strong>in</strong>g a reliable method (ward-based<br />
glucose electrode or laboratory analysis). For all blood glucose tests, <strong>the</strong> time it is performed,<br />
method used, result, and action taken should be clearly documented <strong>in</strong> <strong>the</strong> notes. Fur<strong>the</strong>r research<br />
is needed to defi ne <strong>the</strong> optimal tim<strong>in</strong>g of fi rst blood glucose test <strong>in</strong> babies of diabetic mo<strong>the</strong>rs.<br />
5. Junior paediatric staff should be tra<strong>in</strong>ed <strong>in</strong> <strong>the</strong> management of babies of mo<strong>the</strong>rs with diabetes.<br />
This should <strong>in</strong>clude appreciation of <strong>the</strong> importance of support<strong>in</strong>g early breastfeed<strong>in</strong>g, avoidance<br />
of early blood glucose test<strong>in</strong>g <strong>in</strong> <strong>the</strong> <strong>we</strong>ll baby, and formulation of a written plan agreed with<br />
<strong>the</strong> mo<strong>the</strong>r.<br />
6. Midwives should recognise <strong>the</strong> importance of support<strong>in</strong>g early breastfeed<strong>in</strong>g for women<br />
with diabetes, and <strong>the</strong> need to document this aspect of c<strong>are</strong>.<br />
93
Neonatal c<strong>are</strong> of term babies<br />
References<br />
1. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Maternity services <strong>in</strong> 2002 for women with<br />
type 1 and type 2 diabetes <strong>in</strong> England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2004.<br />
2. Confi dential Enquiry <strong>in</strong>to Maternal and Child Health. Pregnancy <strong>in</strong> women with type 1 and<br />
type 2 diabetes <strong>in</strong> 2002-03, England, Wales and Nor<strong>the</strong>rn Ireland. CEMACH: London; 2005.<br />
3. “The Global Criteria for <strong>the</strong> WHO/UNICEF Baby-Friendly Hospital Initiative.” UNICEF. New York 1992.<br />
4. Macfarlane A, Mungford M. Birth Counts: Statistics of <strong>pregnancy</strong> and childbirth. 2nd ed. Oxford:<br />
National Per<strong>in</strong>atal Epidemiology Unit; 2000.<br />
5. C<strong>are</strong> Recommendation: Recommendations for <strong>the</strong> management of pregnant women with diabetes<br />
(<strong>in</strong>clud<strong>in</strong>g Gestational diabetes). <strong>Diabetes</strong> UK 2005.<br />
6. Management of <strong>Diabetes</strong>. Scottish Intercollegiate Guidel<strong>in</strong>es Network. 2001. SIGN Publication<br />
No.55. Ed<strong>in</strong>burgh: SIGN.<br />
7. National Service Framework for <strong>Diabetes</strong> (England) Standards. Department of Health.<br />
The Stationery Offi ce; London; 2001.<br />
8. Broadfoot M, Britten J, Tapp<strong>in</strong> DM, Mackenzie JM. The Baby Friendly Hospital Initiative and breast<br />
feed<strong>in</strong>g rates <strong>in</strong> Scotland. Arch Dis Child Fetal Neonatal Ed 2005; 90(2):F114-F116.<br />
9. Kramer MS, Chalmers B, Hodnett ED, et al. Promotion of breastfeed<strong>in</strong>g <strong>in</strong>tervention trial (PROBIT).<br />
JAMA 2001; 285(January 24/31):413-420.<br />
10. Levy-Shiff R, Lerman M, Har-Even D, Hod M. Maternal adjustment and <strong>in</strong>fant outcome <strong>in</strong> medically<br />
defi ned high-risk <strong>pregnancy</strong>. Dev Psychol. 2002 Jan;38(1):93-103.<br />
11. Christensson K, Siles C, Moreno L, Belaustequi A, De La Fuente P, Lagercrantz H, Puyol P, W<strong>in</strong>berg<br />
J. Temperature, metabolic adaptation and cry<strong>in</strong>g <strong>in</strong> healthy full-term newborns c<strong>are</strong>d for sk<strong>in</strong>-to-sk<strong>in</strong><br />
or <strong>in</strong> a cot. Acta Paediatr. 1992 Jun-Jul;81(6-7):488-93.<br />
12. Christensson K, Cabrera T, Christensson E, Uvnas-Moberg K, W<strong>in</strong>berg J. Separation distress call <strong>in</strong><br />
<strong>the</strong> human neonate <strong>in</strong> <strong>the</strong> absence of maternal body contact. Acta Paediatr. 1995 May;84(5):468-73.<br />
13. Anderson GC, Moore E, Hepworth J, Bergman N. Early sk<strong>in</strong>-to-sk<strong>in</strong> contact for mo<strong>the</strong>rs and <strong>the</strong>ir<br />
healthy newborn <strong>in</strong>fants. Cochrane Database Syst Rev. 2003;(2):CD003519.<br />
14. Williams AF. Hypoglycaemia of <strong>the</strong> newborn. Review of <strong>the</strong> literature. World Health Organisation,<br />
Geneva 1997.<br />
15. Hawdon JM, Ward Platt MP, Aynsley-Green A. Patterns of metabolic adaptation for preterm and term<br />
<strong>in</strong>fants <strong>in</strong> <strong>the</strong> fi rst neonatal <strong>we</strong>ek. Arch Dis Child 1992; 67:357-65.<br />
16. Infant feed<strong>in</strong>g survey 2000. The Stationery Offi ce: London; 2002.<br />
17. Deshpande S, Ward Platt M. The <strong>in</strong>vestigation and management of neonatal hypoglycaemia.<br />
Sem<strong>in</strong>ars <strong>in</strong> Fetal & Neonatal Medic<strong>in</strong>e (2005). 10, 351-361.<br />
18. de Rooy L, Hawdon Nutritional factors that affect <strong>the</strong> postnatal metabolic adaptation of full-term<br />
small- and large-for-gestational-age <strong>in</strong>fants. J. Pediatrics 2002 Mar;109 (3): E42.<br />
19. Ellis M, Manandhar DS, Manandhar N, Land JM, Patel N, de L Costello AM. Comparison of two<br />
cotside methods for <strong>the</strong> detection of hypoglycaemia among neonates <strong>in</strong> Nepal. Arch Dis Child Fetal<br />
Neonatal Ed 1996 Sep; 75(2):F122-5.<br />
20. Dahlberg M, Whitelaw A. Evaluation of HemoCue Blood Glucose Analyzer for <strong>the</strong> <strong>in</strong>stant diagnosis<br />
of hypoglycaemia <strong>in</strong> newborns. Scand J Cl<strong>in</strong> Lab Invest 1997 Dec; 57(8):719-24.<br />
21. Deshpande SA, Mat<strong>the</strong>ws JN, Platt MP. Measur<strong>in</strong>g blood glucose <strong>in</strong> neonatal units: how does<br />
hemocue comp<strong>are</strong>? Arch Dis Child Fetal Neonatal Ed. 1996 Nov;75(3):F202-8.<br />
94
External commentary<br />
Patricia Hamilton<br />
President, Royal College of Paediatrics and Child Health<br />
I <strong>we</strong>lcome this important study conducted by CEMACH, and <strong>in</strong> particular <strong>the</strong>ir fi nd<strong>in</strong>gs relat<strong>in</strong>g to <strong>the</strong><br />
babies of women with diabetes. This work confi rms what many have suspected, namely that <strong>the</strong> babies<br />
of women with diabetes <strong>are</strong> be<strong>in</strong>g admitted needlessly to neonatal units. Not only is <strong>the</strong>re unnecessary<br />
separation from <strong>the</strong> mo<strong>the</strong>r, but also this <strong>in</strong>evitably has a negative impact on <strong>the</strong> success of breastfeed<strong>in</strong>g.<br />
These two fi nd<strong>in</strong>gs <strong>are</strong> aga<strong>in</strong>st all <strong>the</strong> pr<strong>in</strong>ciples of child-friendly hospitals that <strong>we</strong> <strong>are</strong> try<strong>in</strong>g to endorse and<br />
implement, and <strong>we</strong> hope that as a result of this report <strong>we</strong> can encourage more babies to rema<strong>in</strong> with <strong>the</strong>ir<br />
mo<strong>the</strong>rs and achieve a higher success rate for breastfeed<strong>in</strong>g.<br />
This hav<strong>in</strong>g been said, <strong>the</strong>re is also concern regard<strong>in</strong>g <strong>the</strong> sub-standard neonatal management of<br />
hypoglycaemia, as <strong>we</strong>ll as early feed<strong>in</strong>g. With <strong>the</strong> <strong>best</strong> of <strong>in</strong>tentions, junior tra<strong>in</strong>ees have been mak<strong>in</strong>g<br />
estimates of blood glucose concentrations <strong>in</strong> babies too early and act<strong>in</strong>g unnecessarily at a time when<br />
<strong>the</strong> baby’s metabolism has not yet adjusted to extra uter<strong>in</strong>e life and a low blood glucose concentration<br />
may be physiological. We hope that as a result of this report this practice will be improved.<br />
CEMACH <strong>are</strong> to be congratulated on this c<strong>are</strong>ful piece of work, which will have practical implications<br />
for <strong>the</strong> betterment of <strong>the</strong> health of mo<strong>the</strong>rs and <strong>the</strong>ir babies.<br />
95
13. Conclusions<br />
The St. V<strong>in</strong>cent declaration <strong>in</strong> 1989 1 that ‘<strong>in</strong> fi ve years, <strong>the</strong> outcome of diabetic <strong>pregnancy</strong> should<br />
approximate that of non-diabetic <strong>pregnancy</strong>’, has not yet been achieved. Ho<strong>we</strong>ver, <strong>the</strong>re have been a<br />
number of national and local <strong>in</strong>itiatives focus<strong>in</strong>g on improv<strong>in</strong>g <strong>the</strong> c<strong>are</strong> and outcomes of pregnant women<br />
with type 1 and type 2 diabetes.<br />
The <strong>Diabetes</strong> National Service Framework 2 , fi rst published by <strong>the</strong> Department of Health <strong>in</strong> 2001, set out<br />
a series of national standards for <strong>the</strong> c<strong>are</strong> of people with diabetes. This <strong>in</strong>cluded a standard for <strong>pregnancy</strong><br />
which emphasised <strong>the</strong> importance of tight blood glucose control before conception and dur<strong>in</strong>g <strong>pregnancy</strong><br />
<strong>in</strong> order to optimise <strong>the</strong> chance of a good <strong>pregnancy</strong> outcome. The NSF <strong>in</strong>cludes key <strong>in</strong>terventions,<br />
targets and illustrative service models which <strong>are</strong> available for NHS organisations to draw upon dur<strong>in</strong>g <strong>the</strong><br />
development of <strong>the</strong>ir local services, and local NHS performance will be assessed aga<strong>in</strong>st <strong>the</strong> three-year<br />
and ten-year targets <strong>in</strong> <strong>the</strong> NSF’s Delivery Strategy. 3 In addition, <strong>the</strong> <strong>Diabetes</strong> Commission<strong>in</strong>g Toolkit 4<br />
published by <strong>the</strong> Department of Health <strong>in</strong> November 2006 <strong>in</strong>cludes <strong>best</strong> practice quality markers, evidence<br />
of improvement, and key outcomes that should be sought by commissioners of services. In particular, it<br />
specifi es that <strong>the</strong>re should be evidence of defi ned leadership with<strong>in</strong> specialist services and <strong>in</strong>tegration<br />
bet<strong>we</strong>en primary and secondary c<strong>are</strong> for pre-<strong>pregnancy</strong> c<strong>are</strong> and support.<br />
The CEMACH <strong>Diabetes</strong> Programme has provided a comprehensive national overview of diabetes<br />
maternity services, standards of c<strong>are</strong> for women with diabetes, and <strong>the</strong> possible reasons underly<strong>in</strong>g<br />
suboptimal cl<strong>in</strong>ical c<strong>are</strong> and lack of <strong>in</strong>volvement of women <strong>in</strong> <strong>the</strong>ir own c<strong>are</strong>. This should aid health<br />
c<strong>are</strong> providers and commissioners <strong>in</strong> plann<strong>in</strong>g <strong>the</strong> most appropriate services for <strong>the</strong>ir local populations.<br />
The programme has highlighted a number of <strong>are</strong>as which need to be addressed. These <strong>in</strong>clude poor<br />
preparation for <strong>pregnancy</strong> and <strong>the</strong> need for effective education programmes for women of childbear<strong>in</strong>g<br />
age with diabetes; fragmented preconception c<strong>are</strong> services and variations <strong>in</strong> <strong>the</strong> standard of preconception<br />
c<strong>are</strong> provided by health professionals; <strong>the</strong> <strong>in</strong>creas<strong>in</strong>g problem of women with type 2 diabetes and <strong>the</strong>ir<br />
different needs; and neonatal c<strong>are</strong> policies.<br />
As a response to <strong>the</strong> fi nd<strong>in</strong>g that <strong>the</strong> majority of women with diabetes <strong>are</strong> poorly prep<strong>are</strong>d for <strong>pregnancy</strong>,<br />
CEMACH, toge<strong>the</strong>r with <strong>the</strong> Royal College of General Practitioners and <strong>Diabetes</strong> UK, has published a jo<strong>in</strong>t<br />
<strong>in</strong>formation leafl et for GPs and <strong>the</strong> primary c<strong>are</strong> team. This sets out <strong>in</strong>formation about <strong>the</strong> appropriate c<strong>are</strong><br />
and advice to provide for women of childbear<strong>in</strong>g age with diabetes. The leafl et has been distributed to GPs<br />
throughout <strong>the</strong> UK and is also available for download<strong>in</strong>g from <strong>the</strong> CEMACH <strong>we</strong>bsite.<br />
Poor preparation for <strong>pregnancy</strong> appears to be <strong>the</strong> next barrier to overcome for women with diabetes. The<br />
CEMACH programme has found that pregnant women with type 2 diabetes, who <strong>are</strong> also more likely to be<br />
from a Black, Asian and O<strong>the</strong>r ethnic m<strong>in</strong>ority group and live <strong>in</strong> a deprived <strong>are</strong>a, appear to be less likely<br />
to access preconception c<strong>are</strong> and annual diabetes reviews than women with type 1 diabetes. In order to<br />
better understand <strong>the</strong> reasons and possible solutions to this, CEMACH has commenced a research project<br />
with <strong>the</strong> University College London (UCL) Elizabeth Garrett Anderson Institute for Women’s Health which is<br />
funded by Novo Nordisk. This will <strong>in</strong>vestigate <strong>the</strong> issues affect<strong>in</strong>g preconception c<strong>are</strong> <strong>in</strong> women with type 1<br />
and type 2 diabetes.<br />
It is clear that commissioners and providers of health c<strong>are</strong> <strong>in</strong> both primary and secondary c<strong>are</strong> sett<strong>in</strong>gs<br />
need to work collaboratively. Their jo<strong>in</strong>t aim should be to ensure that women with diabetes <strong>are</strong> better<br />
96
<strong>in</strong>formed and motivated to manage <strong>the</strong>ir diabetes before <strong>the</strong>y become pregnant and that accessible<br />
multidiscipl<strong>in</strong>ary services <strong>are</strong> provided for <strong>the</strong>m before <strong>pregnancy</strong>, dur<strong>in</strong>g <strong>pregnancy</strong> and after delivery.<br />
References<br />
1. Workshop Report. <strong>Diabetes</strong> C<strong>are</strong> and Research <strong>in</strong> Europe: The Sa<strong>in</strong>t V<strong>in</strong>cent Declaration.<br />
Diabetic Med 1990:7;360.<br />
2. Department of Health. National Service Framework for <strong>Diabetes</strong> (England) Standards. London:<br />
The Stationery Offi ce: 2001.<br />
3. Department of Health. National Service Framework for <strong>Diabetes</strong>: Delivery Strategy. London:<br />
Department of Health: 2002 [http://www.dh.gov.uk/assetRoot/04/03/28/23/04032823.pdf] accessed<br />
17 January 2007.<br />
4. Department of Health. <strong>Diabetes</strong> Commission<strong>in</strong>g Toolkit. London: Department of Health: 2006<br />
[http://www.dh.gov.uk/assetRoot/04/14/02/85/04140285.pdf] accessed 17 January 2007.<br />
97
98<br />
Appendix A: Pre-<strong>pregnancy</strong> c<strong>are</strong> pro forma
100<br />
Appendix A: Pre-<strong>pregnancy</strong> c<strong>are</strong> pro forma
101
102<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
103
104<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
105
106<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
107
108<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
109
110<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
111
112<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
113
114<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
115
116<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
117
118<br />
Appendix B: <strong>Diabetes</strong> enquiry pro forma
119
Appendix C<br />
Association bet<strong>we</strong>en demographic and cl<strong>in</strong>ical characteristics, social and lifestyle factors, and cl<strong>in</strong>ical c<strong>are</strong><br />
with major fetal congenital anomaly <strong>in</strong> <strong>the</strong> offspr<strong>in</strong>g of women with type 1 and type 2 diabetes<br />
Association of demographic characteristics with major fetal congenital anomaly <strong>in</strong> <strong>the</strong> offspr<strong>in</strong>g of women<br />
with type 1 and type 2 diabetes<br />
Demographic characteristic<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR [95%<br />
CI]<br />
Adjusted OR<br />
Age - - 1.0 [1.0, 1.1] 1.0 [1.0, 1.1] b<br />
Black, Asian or O<strong>the</strong>r Ethnic<br />
M<strong>in</strong>ority group 22/127 (17) 41/220 (19) 0.9 [0.5, 1.6] 0.6 [0.3, 1.2] a<br />
Primigravidity 52/127 (41) 92/220 (42) 1.0 [0.6, 1.5] 1.1 [0.7, 1.8] a<br />
Maternal social deprivation d - - 1.2 [1.0, 1.4] 1.2 [1.0, 1.4] c<br />
a<br />
adjusted for maternal age and deprivation.<br />
b<br />
adjusted for maternal deprivation.<br />
c<br />
adjusted for maternal age. Odds ratio is for one year <strong>in</strong>crease <strong>in</strong> maternal age.<br />
d<br />
Qu<strong>in</strong>tile of social deprivation derived from postcode of residence. Odds ratio is for unit <strong>in</strong>crease <strong>in</strong> deprivation qu<strong>in</strong>tile.<br />
Association of cl<strong>in</strong>ical characteristics with major fetal congenital anomaly <strong>in</strong> <strong>the</strong> offspr<strong>in</strong>g of women with<br />
type 1 and type 2 diabetes<br />
Cl<strong>in</strong>ical characteristic<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
Body Mass Index (BMI ≥ 30) 53/80 (66) 33/137 (24) 1.6 [0.9, 3.0] 1.3 [0.7, 2.5]<br />
Pre-exist<strong>in</strong>g diabetes complications 22/104 (21) 16/197 (8) 3.0 [1.5, 6.2] 3.1 [1.5, 6.3]<br />
Ret<strong>in</strong>opathy <strong>in</strong> <strong>pregnancy</strong> 34/88 (39) 50/167 (30) 1.5 [0.9, 2.5] 1.5 [0.9, 2.7]<br />
Diabetic nephropathy <strong>in</strong> <strong>pregnancy</strong> 14/103 (13) 14/185 (8) 1.9 [0.9, 4.2] 1.7 [0.7, 3.9]<br />
Recurrent episodes of<br />
hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong> 56/109 (51) 105/205 (51) 1.0 [0.6, 1.6] 1.1 [0.6, 1.8]<br />
Severe hypoglycaemia dur<strong>in</strong>g <strong>pregnancy</strong><br />
(one or more episodes of hypoglycaemia 18/78 (23) 32/167 (19) 1.3 [0.7, 2.4] 1.4 [0.7, 2.8]<br />
requir<strong>in</strong>g external help)<br />
Antenatal evidence of fetal<br />
growth restriction 15/105 (14) 11/218 (5) 3.1 [1.4, 7.2] 3.0 [1.2, 7.0]<br />
Antenatal evidence of macrosomia<br />
(fetal size >90th centile) 21/100 (21) 76/216 (35) 0.5 [0.3, 0.9] 0.5 [0.3, 0.9]<br />
a<br />
adjusted for maternal age and deprivation.<br />
120
Association of social and lifestyle factors with major fetal congenital anomaly <strong>in</strong> <strong>the</strong> offspr<strong>in</strong>g of women<br />
with type 1 and type 2 diabetes<br />
Social and lifestyle factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
Unplanned <strong>pregnancy</strong> 43/75 (57) 55/144 (38) 2.2 [1.2, 3.9] 2.3 [1.3, 4.3]<br />
No contraceptive use <strong>in</strong> <strong>the</strong><br />
12 months before <strong>pregnancy</strong> 33/55 (60) 54/121 (45) 1.9 [1.0, 3.6] 2.0 [1.0, 4.0]<br />
No folic acid commenced prior<br />
to <strong>pregnancy</strong> 49/69 (71) 66/131 (50) 2.4 [1.3, 4.6] 2.3 [1.2, 4.5]<br />
Smok<strong>in</strong>g 35/103 (34) 44/182 (24) 1.6 [1.0, 2.8] 2.2 [1.2, 3.9]<br />
Assessment of suboptimal approach<br />
of <strong>the</strong> woman to manag<strong>in</strong>g her diabetes 80/92 (86) 88/154 (57) 4.6 [2.3, 9.3] 5.0 [2.4, 10.2]<br />
before <strong>pregnancy</strong><br />
Assessment of suboptimal approach<br />
of <strong>the</strong> woman to manag<strong>in</strong>g her diabetes<br />
dur<strong>in</strong>g <strong>pregnancy</strong><br />
62/110 (56) 56/207 (27) 3.5 [2.1, 5.8] 3.5 [2.0, 5.9]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
Association of glycaemic control factors before and dur<strong>in</strong>g <strong>pregnancy</strong> with major fetal congenital anomaly<br />
<strong>in</strong> <strong>the</strong> offspr<strong>in</strong>g of women with type 1 and type 2 diabetes<br />
Glycaemic control factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
No test of glycaemic control<br />
18/76 (24) 24/139 (17) 1.5 [0.7, 3.0] 1.2 [0.6, 2.6]<br />
before <strong>pregnancy</strong><br />
No local targets set for glycaemic control 20/43 (47) 28/86 (33) 1.8 [0.8, 3.9] 1.8 [0.8, 4.1]<br />
Assessment of suboptimal<br />
preconception glycaemic control 96/111 (86) 115/167 (69) 2.9 [1.5, 5.5] 3.6 [1.8, 7.2]<br />
Assessment of suboptimal<br />
1st trimester glycaemic control 94/115 (82) 118/192 (61) 2.8 [1.6, 4.0] 3.3 [1.8, 6.0]<br />
Assessment of suboptimal glycaemic<br />
control after 1st trimester 78/112 (70) 76/209 (37) 4.0 [2.4, 6.8] 5.5 [3.2, 9.6]<br />
Assessment of suboptimal blood glucose<br />
control dur<strong>in</strong>g labour and delivery 38/92 (41) 94/202 (47) 0.8 [0.5, 1.3] 0.9 [0.5, 1.5]<br />
No <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and dextrose<br />
dur<strong>in</strong>g labour and/or delivery 27/115 (23) 31/127 (14) 1.8 [1.0, 3.3] 1.8 [1.0, 3.3]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
121
Appendix C<br />
Association of preconception c<strong>are</strong> factors <strong>in</strong> <strong>the</strong> 12 months prior to <strong>pregnancy</strong> with major fetal congenital anomaly <strong>in</strong><br />
<strong>the</strong> offspr<strong>in</strong>g of women with type 1 and type 2 diabetes<br />
Preconception c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
No contraceptive advice provided before 16/49 (33) 19/83 (23) 1.6 [0.7, 3.6] 1.6 [0.7, 3.8]<br />
<strong>pregnancy</strong><br />
No discussion of <strong>the</strong> follow<strong>in</strong>g specifi c<br />
diabetes issues:<br />
Alcohol 15/36 (42) 19/66 (29) 1.8 [0.8, 4.2] 2.2 [0.9, 5.7]<br />
Diet 10/56 (18) 12/100 (12) 1.6 [0.6, 4.0] 1.6 [0.6, 4.2]<br />
Poor glycaemic control 8/66 (12) 14/117 (12) 1.0 [0.4, 2.6] 0.8 [0.3, 2.2]<br />
Ret<strong>in</strong>opathy 11/50 (22) 25/96 (26) 0.8 [0.4, 1.8] 0.6 [0.3, 1.6]<br />
Nephropathy 13/40 (33) 29/76 (38) 0.8 [0.4, 1.8] 0.5 [0.2, 1.4]<br />
Hypertension 12/39 (31) 23/75 (31) 1.0 [0.4, 2.3] 0.6 [0.2, 1.7]<br />
No discussion of <strong>the</strong> follow<strong>in</strong>g<br />
<strong>pregnancy</strong> issues:<br />
Increased diabetes surveillance 5/61 (8) 7/124 (6) 1.5 [0.5, 4.9] 1.4 [0.4, 5.0]<br />
Increased <strong>pregnancy</strong> surveillance 5/62 (8) 8/124 (6) 1.3 [0.4, 4.1] 1.2 [0.4, 4.0]<br />
Increased risk of <strong>in</strong>duction 10/43 (23) 14/110 (13) 2.1 [0.8, 5.2] 2.3 [0.9, 6.0]<br />
Possible caes<strong>are</strong>an section 7/49 (14) 11/110 (10) 1.5 [0.5, 4.2] 1.8 [0.6, 5.2]<br />
Fetal risks <strong>in</strong> diabetic <strong>pregnancy</strong> 7/52 (13) 7/114 (6) 2.4 [0.8, 7.3] 2.8 [0.8, 9.3]<br />
No dietetic review 24/69 (35) 42/135 (61) 1.2 [0.6, 2.2] 1.2 [0.6, 2.2]<br />
No assessment of <strong>the</strong> follow<strong>in</strong>g diabetes<br />
complications <strong>in</strong> <strong>the</strong> 12 months prior<br />
to <strong>pregnancy</strong>:<br />
Basel<strong>in</strong>e ret<strong>in</strong>al exam<strong>in</strong>ation 19/80 (24) 18/137 (13) 2.1 [1.0, 4.2] 2.0 [0.9, 4.4]<br />
Basel<strong>in</strong>e test of renal function 12/72 (17) 15/133 (11) 1.6 [0.7, 3.6] 1.6 [0.6, 3.9]<br />
Assessment of album<strong>in</strong>uria 22/62 (35) 30/109 (28) 1.5 [0.7, 2.8] 1.4 [0.7, 3.0]<br />
Assessment of suboptimal preconception<br />
c<strong>are</strong> (exclud<strong>in</strong>g glycaemic control) 68/75 (91) 80/134 (60) 6.6 [2.7, 16.2] 7.0 [2.9, 17.1]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
122
Association of diabetes c<strong>are</strong> factors (exclud<strong>in</strong>g glycaemic control) with major fetal congenital anomaly <strong>in</strong> <strong>the</strong><br />
offspr<strong>in</strong>g of women with type 1 and type 2 diabetes<br />
<strong>Diabetes</strong> c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
No ret<strong>in</strong>al assessment dur<strong>in</strong>g<br />
1st trimester or at book<strong>in</strong>g if later 43/111 (39) 49/183 (27) 1.7 [1.0, 2.9] 1.5 [0.9, 2.6]<br />
No referral to ophthalmologist<br />
(if ret<strong>in</strong>opathy present) 4/29 (14) 21/44 (48) 0.2 [0.1, 0.6] 0.1 [0.0, 0.4]<br />
No monitor<strong>in</strong>g for nephropathy 27/118 (23) 26/206 (13) 2.1 [1.1, 3.8] 2.0 [1.1, 3.7]<br />
No test of renal function<br />
(if nephropathy present) 4/12 (33) 5/14 (36) 0.9 [0.2, 4.7] 0.4 [0.1, 3.2]<br />
Assessment of suboptimal diabetes<br />
c<strong>are</strong> dur<strong>in</strong>g <strong>pregnancy</strong> 74/113 (65) 112/204 (55) 1.6 [1.0, 2.5] 1.4 [0.9, 2.3]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
Association of maternity c<strong>are</strong> factors with major fetal congenital anomaly <strong>in</strong> <strong>the</strong> offspr<strong>in</strong>g of women with type 1 and<br />
type 2 diabetes<br />
Maternity c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
Assessment of suboptimal fetal<br />
monitor<strong>in</strong>g (with antenatal evidence<br />
1/13 (8) 1/11 (9) 0.8 [0.0, 16.1] 0.4 [0.0, 8.0]<br />
of growth restricted baby)<br />
Assessment of suboptimal fetal<br />
monitor<strong>in</strong>g (with antenatal evidence<br />
7/20 (35) 27/73 (37) 1.2 [0.4, 3.3] 1.1 [0.3, 3.7]<br />
of fetal size >90th centile)<br />
No discussion of mode and<br />
tim<strong>in</strong>g of delivery 6/102 (6) 4/202 (2) 3.1 [0.9, 11.3] 2.5 [0.6, 9.8]<br />
No adm<strong>in</strong>istration of antenatal<br />
corticosteroids b 12/34 (35) 12/33 (36) 1.0 [0.4, 2.6] 1.0 [0.3, 2.9]<br />
Assessment of suboptimal maternity<br />
c<strong>are</strong> dur<strong>in</strong>g <strong>the</strong> antenatal period 57/125 (46) 95/215 (44) 1.1 [0.7, 1.7] 1.1 [0.7, 1.8]<br />
Assessment of suboptimal maternity<br />
c<strong>are</strong> dur<strong>in</strong>g labour and delivery 44/111 (40) 72/213 (34) 1.3 [0.8, 2.1] 1.3 [0.8, 2.1]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
b<br />
Analysis restricted to babies deliver<strong>in</strong>g from 24+0 to 35+6 <strong>we</strong>eks gestation and exclud<strong>in</strong>g antepartum stillbirths.<br />
123
Appendix C<br />
Association of postnatal c<strong>are</strong> factors with major fetal congenital anomaly <strong>in</strong> <strong>the</strong> offspr<strong>in</strong>g of women with type 1 and<br />
type 2 diabetes<br />
Postnatal c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
No postnatal contraceptive advice 39/83 (47) 26/163 (16) 4.7 [2.5, 3.9] 4.3 [2.3, 8.2]<br />
No written plan for post-delivery<br />
diabetes management 19/100 (19) 25/188 (13) 1.5 [0.8, 3.0] 1.8 [0.9, 3.5]<br />
Assessment of suboptimal<br />
postnatal diabetes c<strong>are</strong> 72/116 (62) 106/211 (50) 1.6 [1.0, 2.6] 1.4 [0.9, 2.3]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
124
Appendix D<br />
Association of demographic and cl<strong>in</strong>ical characteristics, social and lifestyle factors, and cl<strong>in</strong>ical c<strong>are</strong> with all<br />
fetal and neonatal deaths from 20 <strong>we</strong>eks of gestation up to 28 days after delivery <strong>in</strong> babies of women with<br />
type 1 and type 2 diabetes<br />
Association of demographic characteristics with fetal and neonatal death from 20 <strong>we</strong>eks gestation <strong>in</strong> babies<br />
of women with type 1 and type 2 diabetes<br />
Demographic<br />
characteristic<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR<br />
Age - - 1.0 [1.0, 1.0] 1.0 [1.0, 1.0] b<br />
Black, Asian or O<strong>the</strong>r<br />
Ethnic M<strong>in</strong>ority group<br />
35/137 (26) 41/220 (19) 1.5 [0.9, 2.5] 1.2 [0.7, 2.2] a<br />
Primigravidity 65/137 (47) 92/220 (42) 1.3 [0.8, 1.9] 1.4 [0.9, 2.3] a<br />
Maternal social deprivation d - - 1.2 [1.0, 1.4] 1.2 [1.0, 1.4] c<br />
a<br />
adjusted for maternal age and deprivation.<br />
b<br />
adjusted for maternal deprivation.<br />
c<br />
adjusted for maternal age. Odds ratio is for one year <strong>in</strong>crease <strong>in</strong> maternal age.<br />
d<br />
Qu<strong>in</strong>tile of social deprivation derived from postcode of residence. Odds ratio is for unit <strong>in</strong>crease <strong>in</strong> deprivation qu<strong>in</strong>tile.<br />
Association of cl<strong>in</strong>ical characteristics with fetal and neonatal death from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women<br />
with type 1 and type 2 diabetes<br />
Cl<strong>in</strong>ical characteristic<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
Body Mass Index (BMI ≥ 30) 22/81 (27) 33/137 (24) 1.2 [0.6, 2.2] 1.0 [0.5, 2.1]<br />
Pre-exist<strong>in</strong>g diabetes<br />
complications<br />
25/115 (22) 16/197 (8) 3.1 [1.6, 6.3] 2.7 [1.3, 5.5]<br />
Ret<strong>in</strong>opathy <strong>in</strong> <strong>pregnancy</strong> 32/89 (36) 50/167 (30) 1.3 [0.8, 2.3] 1.5 [0.8, 2.6]<br />
Diabetic nephropathy<br />
<strong>in</strong> <strong>pregnancy</strong><br />
17/108 (16) 14/185 (8) 2.3 [1.1, 4.9] 2.0 [0.9, 4.5]<br />
Recurrent episodes of<br />
hypoglycaemia dur<strong>in</strong>g<br />
62/125 (50) 105/205 (51) 0.9 [0.6, 1.5] 1.1 [0.7, 1.8]<br />
<strong>pregnancy</strong><br />
Severe hypoglycaemia dur<strong>in</strong>g<br />
<strong>pregnancy</strong> (one or more<br />
episodes of hypoglycaemia<br />
requir<strong>in</strong>g external help)<br />
16/90 (18) 32/167 (19) 0.9 [0.5, 1.8] 1.0 [0.5, 2.1]<br />
Antenatal evidence of fetal<br />
growth restriction<br />
Antenatal evidence of<br />
macrosomia (fetal size<br />
>90th centile)<br />
a<br />
adjusted for maternal age and deprivation.<br />
14/113 (12) 11/218 (5) 2.7 [1.2, 6.1] 2.6 [1.1, 6.2]<br />
34/109 (31) 76/216 (35) 0.8 [0.5, 1.4] 0.9 [0.6, 1.5]<br />
125
Appendix D<br />
Association of social and lifestyle factors with fetal and neonatal death from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of<br />
women with type 1 and type 2 diabetes<br />
Social and lifestyle factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
Unplanned <strong>pregnancy</strong> 40/88 (45) 55/144 (38) 1.4 [0.8, 2.3] 1.3 [0.7, 2.4]<br />
No contraceptive use <strong>in</strong> <strong>the</strong> 12<br />
months before <strong>pregnancy</strong><br />
49/72 (68) 54/121 (45) 2.6 [1.4, 5.0] 2.5 [1.3, 4.8]<br />
No folic acid commenced prior to<br />
<strong>pregnancy</strong><br />
48/74 (65) 66/131 (50) 1.8 [1.0, 3.3] 2.0 [1.1, 3.7]<br />
Smok<strong>in</strong>g 43/115 (37) 44/182 (24) 1.9 [0.1, 3.1] 2.1 [1.2, 3.6]<br />
Assessment of suboptimal<br />
approach of <strong>the</strong> woman to<br />
manag<strong>in</strong>g her diabetes before<br />
<strong>pregnancy</strong><br />
83/98 (85) 88/154 (57) 4.2 [2.1, 8.1] 4.7 [2.3, 9.3]<br />
Assessment of suboptimal<br />
approach of <strong>the</strong> woman to<br />
manag<strong>in</strong>g her diabetes dur<strong>in</strong>g<br />
<strong>pregnancy</strong><br />
a<br />
adjusted for maternal age and deprivation.<br />
76/124 (61) 56/207 (27) 4.3 [2.6, 7.1] 3.9 [2.4, 6.5]<br />
Association of glycaemic control factors with fetal and neonatal death from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women<br />
with type 1 and type 2 diabetes<br />
Glycaemic control factor<br />
No test of glycaemic control<br />
before <strong>pregnancy</strong><br />
No local targets set for<br />
glycaemic control<br />
Assessment of suboptimal<br />
preconception glycaemic<br />
control<br />
Assessment of suboptimal 1st<br />
trimester glycaemic control<br />
Assessment of suboptimal<br />
glycaemic control after 1st<br />
trimester<br />
Assessment of suboptimal<br />
blood glucose control dur<strong>in</strong>g<br />
labour and delivery<br />
No <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and<br />
dextrose dur<strong>in</strong>g labour and/or<br />
delivery<br />
a<br />
adjusted for maternal age and deprivation.<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
25/90 (28) 24/139 (17) 1.8 [1.0, 3.5] 1.8 [0.9, 3.4]<br />
31/61 (51) 28/86 (33) 2.1 [1.1, 4.3] 2.1 [1.0, 4.4]<br />
103/115 (90) 115/167 (69) 3.9 [1.9, 7.9] 4.3 [2.1, 8.7]<br />
109/129 (85) 118/192 (61) 3.4 [1.9, 6.1] 3.4 [1.9, 6.1]<br />
96/133 (72) 76/209 (37) 4.5 [2.7, 7.5] 5.0 [3.0, 8.4]<br />
47/101 (47) 94/202 (47) 1.0 [0.6, 1.6] 1.1 [0.7, 1.8]<br />
31/133 (26) 31/127 (14) 2.1 [1.2, 3.6] 2.0 [1.2, 3.6]<br />
126
Association of preconception c<strong>are</strong> factors <strong>in</strong> <strong>the</strong> 12 months prior to <strong>pregnancy</strong> with fetal and neonatal death from 20<br />
<strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Preconception c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
No contraceptive advice provided<br />
before <strong>pregnancy</strong><br />
18/51 (35) 19/83 (23) 1.8 [0.8, 4.0] 1.8 [0.8, 4.1]<br />
No discussion of <strong>the</strong> follow<strong>in</strong>g<br />
specifi c diabetes issues:<br />
Alcohol 22/49 (45) 19/66 (29) 2.0 [0.9, 4.4] 2.2 [1.0, 5.2]<br />
Diet 13/65 (20) 12/100 (12) 1.8 [0.8, 4.4] 1.9 [0.8, 4.5]<br />
Poor glycaemic control 12/74 (16) 14/117 (12) 1.4 [0.6, 3.3] 1.3 [0.5, 3.0]<br />
Ret<strong>in</strong>opathy 18/50 (36) 25/96 (26) 1.6 [0.8, 3.4] 1.5 [0.7, 3.3]<br />
Nephropathy 20/47 (43) 29/76 (38) 1.2 [0.6, 2.5] 1.0 [0.5, 2.3]<br />
Hypertension 19/46 (41) 23/75 (31) 1.6 [0.7, 3.5] 1.3 [0.6, 3.1]<br />
No discussion of <strong>the</strong> follow<strong>in</strong>g<br />
<strong>pregnancy</strong> issues:<br />
Increased diabetes surveillance 9/81 (11) 7/124 (6) 2.1 [0.7, 5.9] 1.9 [0.6, 5.5]<br />
Increased <strong>pregnancy</strong><br />
surveillance<br />
9/73 (12) 8/124 (6) 2.0 [0.7, 5.6] 1.8 [0.6, 5.1]<br />
Increased risk of <strong>in</strong>duction 13/51 (25) 14/110 (13) 2.4 [1.0, 5.5] 2.2 [0.9, 5.5]<br />
Possible caes<strong>are</strong>an section 14/62 (23) 11/110 (10) 2.6 [1.1, 6.3] 2.8 [1.1, 7.3]<br />
Fetal risks <strong>in</strong> diabetic<br />
<strong>pregnancy</strong><br />
12/63 (19) 7/114 (6) 3.6 [1.3, 9.9] 3.1 [1.0, 9.6]<br />
No dietetic review 36/84 (43) 42/135 (61) 1.7 [0.9, 2.9] 1.6 [0.9, 3.0]<br />
No assessment of <strong>the</strong> follow<strong>in</strong>g<br />
diabetes complications <strong>in</strong> <strong>the</strong> 12<br />
months prior to <strong>pregnancy</strong>:<br />
Basel<strong>in</strong>e ret<strong>in</strong>al exam<strong>in</strong>ation 23/88 (26) 18/137 (13) 2.3 [1.2, 4.7] 2.4 [1.2, 5.1]<br />
Basel<strong>in</strong>e test of renal function 19/79 (24) 15/133 (11) 2.5 [1.2, 5.3] 2.8 [1.2, 6.2]<br />
Assessment of album<strong>in</strong>uria 28/70 (40) 30/109 (28) 1.8 [0.9, 3.3] 1.9 [1.0, 3.8]<br />
Assessment of suboptimal<br />
preconception c<strong>are</strong> (exclud<strong>in</strong>g<br />
glycaemic control<br />
71/84 (85) 80/134 (60) 3.7 [1.8, 7.5] 4.6 [2.2, 9.9]<br />
a<br />
adjusted for maternal age and deprivation.<br />
127
Appendix D<br />
Association of diabetes c<strong>are</strong> factors with fetal and neonatal death from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with<br />
type 1 and type 2 diabetes<br />
<strong>Diabetes</strong> c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
No ret<strong>in</strong>al assessment dur<strong>in</strong>g<br />
1st trimester or at book<strong>in</strong>g if 43/120 (36) 49/183 (27) 1.5 [0.9, 2.5] 1.4 [0.8, 2.3]<br />
later<br />
No referral to ophthalmologist<br />
(if ret<strong>in</strong>opathy present)<br />
9/26 (35) 21/44 (48) 0.6 [0.2, 1.6] 0.4 [0.1, 1.3]<br />
No monitor<strong>in</strong>g for nephropathy 27/130 (21) 26/206 (13) 1.8 [1.0, 3.3] 1.8 [1.0, 3.2]<br />
No test of renal function (if<br />
nephropathy present)<br />
9/16 (56) 5/14 (36) 2.3 [0.5, 10.7] 2.7 [0.5, 13.8]<br />
Assessment of suboptimal<br />
diabetes c<strong>are</strong> dur<strong>in</strong>g<br />
<strong>pregnancy</strong><br />
90/128 (70) 112/204 (55) 2.0 [1.2, 3.1] 1.8 [1.1, 3.0]<br />
a<br />
adjusted for maternal age and deprivation.<br />
Association of maternity c<strong>are</strong> factors with fetal and neonatal death from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with<br />
type 1 and type 2 diabetes<br />
Maternity c<strong>are</strong> factor<br />
Assessment of suboptimal<br />
fetal monitor<strong>in</strong>g (with<br />
antenatal evidence of growth<br />
restricted baby)<br />
Assessment of suboptimal<br />
fetal monitor<strong>in</strong>g (with<br />
antenatal evidence of fetal<br />
size >90th centile)<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
6/14 (43) 1/11 (9) 7.5 [0.6, 95.5] 4.4 [0.4, 49.9]<br />
29/33 (88) 27/73 (37) 15.8 [4.0, 61.5] 18.3 [5.6, 59.6]<br />
No discussion of mode and<br />
tim<strong>in</strong>g of delivery<br />
11/111 (10) 4/202 (2) 5.45 [1.7, 17.9] 5.0 [1.5, 16.5]<br />
No adm<strong>in</strong>istration of antenatal<br />
corticosteroids b 6/14 (43) 12/33 (36) 1.3 [0.4, 4.8] 1.1 [0.3, 4.4]<br />
Assessment of suboptimal<br />
maternity c<strong>are</strong> dur<strong>in</strong>g <strong>the</strong> 91/132 (69) 95/215 (44) 2.8 [1.8, 4.5] 2.9 [1.8, 4.7]<br />
antenatal period<br />
Assessment of suboptimal<br />
maternity c<strong>are</strong> dur<strong>in</strong>g labour<br />
and delivery<br />
51/125 (41) 72/213 (34) 1.4 [0.9, 2.1] 1.3 [0.8, 2.2]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
b<br />
Analysis restricted to babies deliver<strong>in</strong>g from 24+0 to 35+6 <strong>we</strong>eks gestation and exclud<strong>in</strong>g antepartum stillbirths.<br />
128
Association of postnatal c<strong>are</strong> factors with fetal and neonatal death from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with<br />
type 1 and type 2 diabetes<br />
Postnatal c<strong>are</strong> factor<br />
No postnatal contraceptive<br />
advice<br />
No written plan for<br />
post-delivery diabetes<br />
management<br />
Assessment of suboptimal<br />
postnatal diabetes c<strong>are</strong><br />
a<br />
adjusted for maternal age and deprivation.<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
41/89 (46) 26/163 (16) 4.5 [2.4, 8.4] 4.8 [2.6, 9.0]<br />
20/120 (17) 25/188 (13) 1.3 [0.7, 2.5] 1.4 [0.7, 2.8]<br />
86/127 (68) 106/211 (50) 2.1 [1.3, 3.3] 2.1 [1.3, 3.5]<br />
129
Appendix E<br />
Association bet<strong>we</strong>en demographic and cl<strong>in</strong>ical characteristics, social and lifestyle issues, and cl<strong>in</strong>ical c<strong>are</strong><br />
with fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital anomaly) from 20 <strong>we</strong>eks of gestation up to<br />
28 days after delivery <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Association bet<strong>we</strong>en demographic characteristics of fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital<br />
anomaly) from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Demographic characteristic<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR<br />
Age - - 1.0 [1.0, 1.0] 1.0 [1.0, 1.0] b<br />
Black, Asian or O<strong>the</strong>r Ethnic<br />
M<strong>in</strong>ority group<br />
25/95 (26) 41/220 (19) 1.6 [0.9, 2.8] 1.3 [0.7, 2.5] a<br />
Primigravidity 48/95 (51) 92/220 (42) 1.4 [0.9, 2.3] 1.5 [0.9, 2.7] a<br />
Maternal social deprivation d - - 1.2 [1.0, 1.4] 1.2 [1.0, 1.5] c<br />
a<br />
adjusted for maternal age and deprivation.<br />
b<br />
adjusted for maternal deprivation.<br />
c<br />
adjusted for maternal age. Odds ratio is for one year <strong>in</strong>crease <strong>in</strong> maternal age.<br />
d<br />
Qu<strong>in</strong>tile of social deprivation derived from postcode of residence. Odds ratio is for unit <strong>in</strong>crease <strong>in</strong> deprivation qu<strong>in</strong>tile.<br />
Association bet<strong>we</strong>en cl<strong>in</strong>ical characteristics of fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital anomaly)<br />
from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Cl<strong>in</strong>ical characteristic<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR [95% CI]<br />
Adjusted OR a<br />
Body Mass Index (BMI ≥ 30) 13/56 (23) 33/137 (24) 1.0 [0.5, 2.0] 0.8 [0.3, 1.7]<br />
Pre-exist<strong>in</strong>g diabetes<br />
complications<br />
15/78 (19) 16/197 (8) 2.7 [1.3, 5.8] 2.1 [0.9, 4.8]<br />
Ret<strong>in</strong>opathy <strong>in</strong> <strong>pregnancy</strong> 21/61 (34) 50/167 (30) 1.2 [0.7, 2.3] 1.3 [0.7, 2.6]<br />
Diabetic nephropathy <strong>in</strong><br />
<strong>pregnancy</strong><br />
14/71 (20) 14/185 (8) 3.0 [1.3, 6.8] 2.6 [1.1, 6.1]<br />
Recurrent episodes of<br />
hypoglycaemia dur<strong>in</strong>g<br />
42/86 (49) 105/205 (51) 0.9 [0.6, 1.5] 1.1 [0.6, 1.9]<br />
<strong>pregnancy</strong><br />
Severe hypoglycaemia dur<strong>in</strong>g<br />
<strong>pregnancy</strong> (one or more<br />
episodes of hypoglycaemia<br />
requir<strong>in</strong>g external help)<br />
13/66 (20) 32/167 (19) 1.0 [0.5, 2.1] 1.2 [0.5, 2.6]<br />
Antenatal evidence of fetal<br />
growth restriction<br />
Antenatal evidence of<br />
macrosomia (fetal size >90th<br />
centile)<br />
a<br />
Adjusted for maternal age and deprivation.<br />
11/81 (14) 11/218 (5) 3.0 [1.2, 7.2] 3.0 [1.2, 7.5]<br />
32/79 (41) 76/216 (35) 1.3 [0.7, 2.1] 1.4 [0.8, 2.4]<br />
130
Association bet<strong>we</strong>en social and lifestyle factors of fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital anomaly)<br />
from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Social and lifestyle factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR [95% CI]<br />
Adjusted OR a<br />
Unplanned <strong>pregnancy</strong> 29/66 (44) 55/144 (38) 1.3 [0.7, 2.3] 1.2 [0.6, 2.3]<br />
No contraceptive use <strong>in</strong> <strong>the</strong> 12<br />
months before <strong>pregnancy</strong><br />
38/53 (72) 54/121 (45) 3.1 [1.5, 6.5] 2.7 [1.3, 5.8]<br />
No folic acid commenced prior<br />
to <strong>pregnancy</strong><br />
34/51 (67) 66/131 (50) 2.0 [1.0, 3.9] 2.1 [1.0, 4.4]<br />
Smok<strong>in</strong>g 28/80 (35) 44/182 (24) 1.7 [1.0, 3.0] 1.7 [0.9, 3.2]<br />
Assessment of suboptimal<br />
approach of <strong>the</strong> woman to<br />
manag<strong>in</strong>g her diabetes before<br />
<strong>pregnancy</strong><br />
57/67 (85) 88/154 (57) 4.3 [2.0, 9.3] 4.8 [2.1, 10.7]<br />
Assessment of suboptimal<br />
approach of <strong>the</strong> woman to<br />
manag<strong>in</strong>g her diabetes dur<strong>in</strong>g<br />
<strong>pregnancy</strong><br />
a<br />
Adjusted for maternal age and deprivation.<br />
56/87 (64) 56/207 (27) 4.9 [2.8, 8.6] 4.4 [2.5, 7.8]<br />
Association bet<strong>we</strong>en glycaemic control factors of fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital anomaly)<br />
from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Glycaemic control factor<br />
No test of glycaemic control<br />
before <strong>pregnancy</strong><br />
No evidence of local targets<br />
set for glycaemic control<br />
Assessment of suboptimal<br />
preconception glycaemic<br />
control<br />
Assessment of suboptimal 1st<br />
trimester glycaemic control<br />
Assessment of suboptimal<br />
glycaemic control after 1st<br />
trimester<br />
Assessment of suboptimal<br />
blood glucose control dur<strong>in</strong>g<br />
labour and delivery<br />
No <strong>in</strong>travenous <strong>in</strong>sul<strong>in</strong> and<br />
dextrose dur<strong>in</strong>g labour and/or<br />
delivery<br />
a<br />
Adjusted for maternal age and deprivation.<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
18/63 (29) 24/139 (17) 1.9 [0.9, 3.9] 1.9 [0.9, 4.0]<br />
24/47 (51) 28/86 (33) 2.2 [1.0, 4.6] 2.2 [1.0, 4.9]<br />
69/76 (91) 115/167 (69) 4.5 [1.9, 10.6] 4.8 [2.0, 11.6]<br />
77/89 (87) 118/192 (61) 4.0 [2.0, 8.1] 3.9 [1.9, 7.8]<br />
68/93 (73) 76/209 (37) 4.8 [2.7, 8.4] 5.1 [2.9, 9.1]<br />
35/70 (50) 94/202 (47) 1.2 [0.7, 2.0] 1.2 [0.7, 2.2]<br />
21/93 (23) 31/127 (14) 1.8 [0.9, 3.3] 1.8 [0.9, 3.4]<br />
131
Appendix E<br />
Association bet<strong>we</strong>en preconception c<strong>are</strong> factors <strong>in</strong> <strong>the</strong> 12 months prior to <strong>pregnancy</strong> of fetal and neonatal deaths<br />
(exclud<strong>in</strong>g major fetal congenital anomaly) from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2<br />
diabetes<br />
Preconception c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
No contraceptive advice<br />
provided before <strong>pregnancy</strong><br />
12/36 (33) 19/83 (23) 1.7 [0.7, 4.0] 1.6 [0.7, 3.8]<br />
No discussion of <strong>the</strong><br />
follow<strong>in</strong>g specifi c diabetes<br />
issues:<br />
Alcohol 16/34 (47) 19/66 (29) 2.2 [0.9, 5.3] 2.7 [1.1, 6.9]<br />
Diet 10/47 (21) 12/100 (12) 2.0 [0.8, 5.0] 2.1 [0.8, 5.4]<br />
Poor glycaemic control 10/52 (19) 14/117 (12) 1.8 [0.7, 4.3] 1.6 [0.7, 4.0]<br />
Ret<strong>in</strong>opathy 14/33 (42) 25/96 (26) 2.1 [0.9, 4.9] 2.0 [0.8, 4.7]<br />
Nephropathy 15/34 (44) 29/76 (38) 1.3 [0.6, 2.9] 1.2 [0.5, 2.8]<br />
Hypertension 15/32 (47) 23/75 (31) 2.0 [0.8, 4.7] 1.7 [0.7, 4.3]<br />
No discussion of <strong>the</strong><br />
follow<strong>in</strong>g <strong>pregnancy</strong> issues:<br />
Increased diabetes<br />
surveillance<br />
8/62 (13) 7/124 (6) 2.5 [0.8, 7.3] 2.3 [0.8, 6.8]<br />
Increased <strong>pregnancy</strong><br />
surveillance<br />
8/55 (15) 8/124 (6) 2.5 [0.9, 7.0] 2.2 [0.8, 6.5]<br />
Increased risk of <strong>in</strong>duction 11/40 (28) 14/110 (13) 2.6 [1.1, 6.5] 2.3 [0.9, 6.2]<br />
Possible caes<strong>are</strong>an section 13/46 (28) 11/110 (10) 3.6 [1.4, 8.9] 3.7 [1.4, 10.2]<br />
Fetal risks <strong>in</strong> diabetic<br />
<strong>pregnancy</strong><br />
10/46 (22) 7/114 (6) 4.3 [1.5, 12.4] 3.6 [1.1, 11.6]<br />
No dietetic review 22/60 (37) 42/135 (61) 1.3 [0.7, 2.4] 1.3 [0.6, 2.5]<br />
No assessment of<br />
<strong>the</strong> follow<strong>in</strong>g diabetes<br />
complications <strong>in</strong> <strong>the</strong> 12<br />
months prior to <strong>pregnancy</strong>:<br />
Basel<strong>in</strong>e ret<strong>in</strong>al<br />
exam<strong>in</strong>ation<br />
17/61 (28) 18/137 (13) 2.6 [1.2, 5.5] 2.6 [1.2, 5.9]<br />
Basel<strong>in</strong>e test of<br />
renal function<br />
14/58 (24) 15/133 (11) 2.5 [1.1, 5.7] 2.6 [1.1, 6.3]<br />
Assessment of album<strong>in</strong>uria 19/54 (35) 30/109 (28) 1.4 [0.7, 2.9] 1.6 [0.8, 3.3]<br />
Assessment of suboptimal<br />
preconception c<strong>are</strong><br />
(exclud<strong>in</strong>g glycaemic<br />
control)<br />
48/58 (83) 80/134 (60) 3.2 [1.5, 7.1] 4.0 [0.7, 9.4]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
132
Association bet<strong>we</strong>en diabetes c<strong>are</strong> factors of fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital anomaly)<br />
from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
<strong>Diabetes</strong> c<strong>are</strong> factor<br />
No referral to ophthalmologist<br />
(if ret<strong>in</strong>opathy present)<br />
No monitor<strong>in</strong>g for<br />
nephropathy<br />
No test of renal function (if<br />
nephropathy present)<br />
Assessment of suboptimal<br />
diabetes c<strong>are</strong> dur<strong>in</strong>g<br />
<strong>pregnancy</strong><br />
a<br />
Adjusted for maternal age and deprivation.<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR [95% CI]<br />
Adjusted OR a<br />
27/83 (33) 49/183 (27) 1.3 [0.8, 2.3] 1.2 [0.7, 2.2]<br />
6/16 (38) 21/44 (48) 0.7 [0.2, 2.2] 0.6 [0.2, 2.3]<br />
19/91 (21) 26/206 (13) 1.8 [1.0, 3.5] 1.8 [0.9, 3.5]<br />
8/14 (58) 5/14 (36) 2.4 [0.5, 11.7] 2.9 [0.5, 15.8]<br />
67/91 (74) 112/204 (55) 2.3 [1.3, 4.0] 2.2 [1.3, 3.9]<br />
Association bet<strong>we</strong>en maternity c<strong>are</strong> factors of fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital anomaly)<br />
from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Maternity c<strong>are</strong> factor<br />
Assessment of suboptimal<br />
fetal monitor<strong>in</strong>g (with<br />
antenatal evidence of<br />
growth restricted baby)<br />
Assessment of suboptimal<br />
fetal monitor<strong>in</strong>g (with<br />
antenatal evidence of fetal<br />
size >90th centile)<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR<br />
[95% CI]<br />
Adjusted OR a<br />
5/11 (45) 1/11 (9) 8.3 [0.6, 119.3] 5.2 [0.4, 62.8]<br />
28/32 (88) 27/73 (37) 15.2 [3.9, 59.2] 17.7 [5.4, 57.6]<br />
No discussion of mode and<br />
tim<strong>in</strong>g of delivery<br />
9/79 (12) 4/202 (2) 6.7 [1.9, 23.0] 5.9 [1.7, 20.7]<br />
No adm<strong>in</strong>istration of<br />
antenatal corticosteroids b 2/7 (29) 12/33 (36) 0.7 [0.1, 4.3] 0.4 [0.0, 4.1]<br />
Assessment of suboptimal<br />
maternity c<strong>are</strong> dur<strong>in</strong>g <strong>the</strong> 68/90 (76) 95/215 (44) 3.9 [2.2, 7.0] 4.2 [2.3, 7.4]<br />
antenatal period<br />
Assessment of suboptimal<br />
maternity c<strong>are</strong> dur<strong>in</strong>g labour<br />
and delivery<br />
34/88 (39) 72/213 (34) 1.2 [0.7, 2.1] 1.2 [0.7, 2.1]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
b<br />
Analysis restricted to babies deliver<strong>in</strong>g from 24+0 to 35+6 <strong>we</strong>eks gestation and exclud<strong>in</strong>g antepartum stillbirths.<br />
133
Appendix E<br />
Association bet<strong>we</strong>en postnatal c<strong>are</strong> factors of fetal and neonatal deaths (exclud<strong>in</strong>g major fetal congenital anomaly)<br />
from 20 <strong>we</strong>eks gestation <strong>in</strong> babies of women with type 1 and type 2 diabetes<br />
Postnatal c<strong>are</strong> factor<br />
Cases<br />
n/N (%)<br />
Controls<br />
n/N (%)<br />
Crude OR [95% CI]<br />
Adjusted OR a<br />
No postnatal contraceptive advice 24/60 (40) 26/163 (16) 3.5 [1.8, 7.0] 4.1 [2.0, 8.2]<br />
No written plan for post-delivery<br />
diabetes management<br />
12/84 (14) 25/188 (13) 1.1 [0.5, 2.3] 1.2 [0.5, 2.6]<br />
Assessment of suboptimal<br />
postnatal diabetes c<strong>are</strong><br />
61/87 (70) 106/211 (50) 2.3 [1.4, 4.0] 2.5 [1.4, 4.3]<br />
a<br />
Adjusted for maternal age and deprivation.<br />
134
Appendix F - CEMACH advisory groups & contributors<br />
Appendix F - CEMACH advisory groups & contributors<br />
<strong>Diabetes</strong> Professional Advisory Group<br />
Stephen Walk<strong>in</strong>shaw Chair, Consultant Obstetrician, Liverpool Women’s Hospital<br />
Jean Chapple Consultant <strong>in</strong> Per<strong>in</strong>atal Epidemiology, Westm<strong>in</strong>ster Primary C<strong>are</strong> Trust<br />
Richard Congdon CEMACH Chief Executive<br />
Simon Court Consultant Paediatrician, Newcastle General Hospital (<strong>Diabetes</strong> UK)<br />
Pat Doyle Epidemiologist, London School of Hygiene & Tropical Medic<strong>in</strong>e<br />
Kate Flem<strong>in</strong>g CEMACH Senior Data Analyst (until November 2006)<br />
Shona Golightly CEMACH Director of Development and Research<br />
Ol<strong>we</strong>n Harrison <strong>Diabetes</strong> Nurse Specialist, North Hampshire Hospital<br />
Jane Hawdon Consultant Neonatologist, University College London Hospitals<br />
Gillian Hawthorne Consultant <strong>Diabetes</strong> Physician, Newcastle General Hospital<br />
Anita Holdcroft Consultant Anaes<strong>the</strong>tist, Chelsea and Westm<strong>in</strong>ster Hospital, London<br />
Julie Maddocks CEMACH Regional Manager (North West & West Midlands)<br />
Mary Mac<strong>in</strong>tosh CEMACH Medical Director (Until May 2006)<br />
Rona McCandlish Professor of Midwifery, National Per<strong>in</strong>atal Epidemiology Unit<br />
Jo Modder CEMACH Cl<strong>in</strong>ical Director (Obstetrics)<br />
Alison Miller CEMACH Programme Director and Midwifery Lead<br />
Mary Pierce Royal College of General Practitioners representative<br />
Bob Young Consultant <strong>Diabetes</strong> Physician, Hope Hospital, Salford<br />
CEMACH Central Offi ce Staff<br />
Dom<strong>in</strong>ique Acolet Cl<strong>in</strong>ical Director (Per<strong>in</strong>atal Epidemiology)<br />
Naufil Alam Data Analyst<br />
Jessica Berenston-Shaw National Cl<strong>in</strong>ical Projects Advisor<br />
John Bolton Accountant<br />
Nicola Cogdell Adm<strong>in</strong>istrative Assistant<br />
Kirshnee Chetty Adm<strong>in</strong>istrative Assistant (until February 2007)<br />
Richard Congdon Chief Executive<br />
Shona Golightly Director of Research and Development<br />
Rosie Houston Assistant Projects Manager<br />
Mary Humphreys Offi ce Adm<strong>in</strong>istrator<br />
Alison Miller Programme Director and Midwifery Lead<br />
Jo Modder Cl<strong>in</strong>ical Director (Obstetrics)<br />
Iman Mortagy Data Analyst<br />
Dharmishta Parmar Data Manager<br />
Gale Pearson Cl<strong>in</strong>ical Director (Child Health)<br />
Maureen Wilson Committee Adm<strong>in</strong>istrator<br />
135
Appendix F - CEMACH advisory groups & contributors<br />
CEMACH Regional Managers<br />
Lesley Anson Yorkshire & Humberside (until March 2006)<br />
Angela Bell Nor<strong>the</strong>rn Ireland<br />
Melanie Gompels South East and <strong>the</strong> Channel Islands<br />
Carol Hay East of England<br />
Julie Maddocks North West / West Midlands<br />
Marjorie Renwick North East<br />
Dawn Roberts Wales<br />
Rachel Thomas London<br />
Rosie Thompson South West<br />
Sue Wood East Midlands and Yorkshire & Humberside<br />
Panel Chairs<br />
Carol Axon<br />
Philip Banfield<br />
Miriam Bonduelle<br />
Ian Casson<br />
Jean Chapple<br />
Elizabeth Draper<br />
D A Evans<br />
Robert Fraser<br />
Malcolm Griffiths<br />
Paul Jenn<strong>in</strong>gs<br />
Boon Lim<br />
Michael M<strong>are</strong>sh<br />
Heul<strong>we</strong>n Morgan<br />
C M Ritchie<br />
A I Traub<br />
Mat<strong>the</strong>w Coleman<br />
Michael Gillmer<br />
Andrew Johnson<br />
Michael Qu<strong>in</strong>n<br />
Doro<strong>the</strong>a Smith<br />
Derek Tuffnell<br />
Christopher Watts<br />
Sarah Wilson<br />
Christopher Wright<br />
Midwife, South West<br />
Consultant Obstetrician, Wales<br />
Consultant Obstetrician, Wales<br />
Consultant Physician, North West<br />
Consultant <strong>in</strong> Per<strong>in</strong>atal Epidemiology, London<br />
Senior Research Fellow <strong>in</strong> Reproductive and Paediatric Epidemiology, East Midlands<br />
Consultant Obstetrician, North East<br />
Reader <strong>in</strong> Reproductive & Developmental Medic<strong>in</strong>e, Consultant <strong>in</strong> Obstetrics<br />
& Gynaecology, Yorkshire & Humberside<br />
Consultant Obstetrician & Gynaecologist, East of England<br />
Consultant Physician <strong>in</strong> <strong>Diabetes</strong> and Endocr<strong>in</strong>ology, Yorkshire & Humberside<br />
Consultant Obstetrician, East of England<br />
Consultant Obstetrician, North West<br />
Consultant Obstetrician, London<br />
Consultant Physician, Nor<strong>the</strong>rn Ireland<br />
Consultant Obstetrician, Nor<strong>the</strong>rn Ireland<br />
Consultant Obstetrician, South East<br />
Consultant Obstetrician, South East<br />
Consultant Physician, South West<br />
Consultant Paediatrician, South West<br />
Midwife, South East<br />
Consultant Obstetrician, Yorkshire & Humberside<br />
Director of Public Health, London<br />
Director of Public Health, East Midlands<br />
Consultant Per<strong>in</strong>atal Pathologist, North East<br />
136
Peer Revie<strong>we</strong>rs<br />
Tim Clayton<br />
Anne Dornhurst<br />
Pat Doyle<br />
Ian Greer<br />
Michael K<strong>in</strong>sella<br />
Michael M<strong>are</strong>sh<br />
Mary Mac<strong>in</strong>tosh<br />
David McCance<br />
Christopher Watts<br />
Joy Williams<br />
Senior Lecturer <strong>in</strong> Medical Statistics, London School of Hygiene & Tropical Medic<strong>in</strong>e<br />
Consultant Physician & Honorary Cl<strong>in</strong>ical Senior Lecturer, Imperial College, London<br />
Epidemiologist, London School of Hygiene & Tropical Medic<strong>in</strong>e<br />
Consultant Obstetrician, Dean of Hull York Medical School<br />
Consultant Anaes<strong>the</strong>tist, St Michael’s Hospital, Bristol<br />
Consultant Obstetrician, St Mary’s Hospital for Women and Children, Manchester<br />
Director, National Chlamydia Screen<strong>in</strong>g Programme<br />
Consultant Physician, Royal Victoria Hospital, Belfast<br />
Director of Public Health, Lewisham Primary C<strong>are</strong> Trust<br />
Senior <strong>Diabetes</strong> Nurse Specialist, Worth<strong>in</strong>g Hospital<br />
Neonatal Enquiry Steer<strong>in</strong>g Group<br />
Jane Hawdon Chair, Neonatologist, University College London Hospitals<br />
Dom<strong>in</strong>ique Acolet CEMACH Cl<strong>in</strong>ical Director (Per<strong>in</strong>atal Epidemiology)<br />
Kate Flem<strong>in</strong>g Senior Data Analyst, CEMACH (until November 2006)<br />
Caron Gooch <strong>Diabetes</strong> Specialist Midwife, Lewisham<br />
Rosie Houston CEMACH Assistant Projects Manager<br />
Alree Hunt Modern Matron, SCBU, Queen Elizabeth, Woolwich<br />
Alison Johns Transitional C<strong>are</strong> Sister, Neonatal Services, University College London Hospitals<br />
Jana Kovar National Projects Manager, CEMACH (until October 2006)<br />
Alison Leaf Consultant Neonatologist, Southmead Hospital, Bristol<br />
Alison Miller CEMACH Programme Director and Midwifery Lead<br />
Joan Oliver Head Neonatal Nurse, SCBU, Wansbeck General Hospital<br />
Just<strong>in</strong>e Pepperell Family Support Manager, BLISS<br />
Laura de Rooy Consultant Neonatologist, St George’s Hospital, London<br />
Mart<strong>in</strong> Ward Platt Consultant Paediatrician, Royal Victoria Infi rmary, Newcastle<br />
Anthony Williams Consultant Paediatrician, St George’s Hospital, London<br />
137
Appendix F - CEMACH advisory groups & contributors<br />
CEMACH Board<br />
Michael We<strong>in</strong>dl<strong>in</strong>g<br />
Jean Chapple<br />
Griselda Cooper<br />
Beverley Fitzsimons<br />
Steve Gould<br />
Ian Greer<br />
Sheila Holl<strong>in</strong>s<br />
Deirdre Kelly<br />
Jenni McAughey<br />
Neil McIntosh<br />
Ann Seymour<br />
Louise Silverton<br />
Allan Templeton<br />
Una Rennard<br />
Chair<br />
Faculty of Public Health<br />
Royal College of Anaes<strong>the</strong>tists<br />
Lay representative<br />
Royal College of Pathologists<br />
Chair, CEMACH National Advisory Committee for Maternal Health<br />
Royal College of Psychiatrists<br />
Chair, CEMACH National Advisory Committee for Child Health<br />
Chair of RCGP Nor<strong>the</strong>rn Ireland Council<br />
Royal College of Paediatrics and Child Health<br />
Lay representative<br />
Royal College of Midwives<br />
Royal College of Obstetricians & Gynaecologists<br />
Lay representative<br />
<strong>Diabetes</strong> Enquiry Panel Assessors (can be accessed at www.cemach.org.uk)<br />
<strong>Diabetes</strong> Multidiscipl<strong>in</strong>ary Resource Group (can be accessed at www.cemach.org.uk)<br />
138
Published February 2007 by CEMACH<br />
CEMACH, Chiltern Court, 188 Baker Street, London, NW1 5SD<br />
Tel: 0207 486 1191 Fax: 0207 486 6543<br />
Email: <strong>in</strong>fo@cemach.org.uk Website: www.cemach.org.uk<br />
ISBN: 978-0-9533536-3-7<br />
UK Price £15 Ireland and rest of Europe Price 23€<br />
To obta<strong>in</strong> fur<strong>the</strong>r copies of this report please email <strong>in</strong>fo@cemach.org.uk or visit www.cemach.org.uk