Dianatal® Obstetric Gel

Experiences with Dianatal® in
obstructed delivery
Maritta Kühnert
Dept. Of Obstetrics and Perinatology
Philipps-University Marburg

Different forces during Childbirth:
Beneficial during labor:
• labor
• gravity
• normal pelvic sizes and
form
Inhibitory during labor:
• Elasticity of the cervix
• friction between:
fetus + birth canal
• borderline pelvic sizes
or form

Which Substrates are available
Substrate:
•
• Lubricating jelly
Attributes + Quality:
• Hygiene Very fluid
• Olive oil
• Oil for perineal massage
.
• Hygiene Fluid
• More friction in
combination with
amniotic fluid; essential
oils can irritate the eyes
of the newborn; foreign
body reactions may
occur

Which Substrates are available
Substrate:
•
• Dianatal® Obstetric Gel:
Attributes + Quality :
• Sterile single-use
packaged; tested, nonallergenic,
latex-free,
examined in accordance
with international and
FDA guidelines concerning
its biocompatibility;
electroconductive; 2
pharmaceutical forms
available: for Stage 1 =
mucous; Stage 2 = liquid

Preventive use:
Starting at the onset of regular contractions
in primiparous and multiparous women with vaginal
delivery intend
(application during labor stage 1 and labor stage 2)

Therapeutic use:
(application in case of)
1. labor arrest
2. obstructed or delayed delivery
3. preterm delivery
4. non-lubricated vagina after several applications of
prostaglandin gel in case of induction of labor
5. facilitation of vaginal operative procedures
6. facilitation of manual placenta delivery
7. indication for labor facilitation in case of history with
C- section, state after obstructed labor, big baby, borderline
pelvic sizes

Objective of the Study:
Primary aim:
• Using Dianatal® Obstetric
Gel in case of obstructed
delivery can reduce the
number of operative
deliveries minus 20%
secundary aims:
• Labor Stage I is
significantly reduced
• Labor Stage II is
significantly reduced

Protocol of MarburgStudy:
The patient will be informed to have the possibility to
take part in the Dianatal® study
The patient gets a written information concerning the
study and has a confidential discussion with midwife
or obstetrician
In case of to participate in the study the patient has to
sign for informed consent:
Thereafter the study can start!

Definition of prolonged Labor:
Referring „to dynamic“ aspects:
•
• Stage I of Labor = prolonged:
Dilatation < 1 cm/h
• Stage II of Labor = prolonged:
descent of the head of the unborn < 1 cm/h
.

Study design:
Test group :
•
Application of
Dianatal® Obstetric Gel
after informed consent and
randomization
Control group:
No application of
Dianatal® Obstetric Gel
after informed consent and
randomization

Study design:
Eligible criteria:
• Patient 18
Patient 18-40 years old
• Patient, who can and like to deliver vaginal
• estimated birth weight by ultrasound
between 2000-4000 g
• pregnancy of 37+0 to 42. weeks of gestation
• Written informed consent

Study design:
Non-eligible criteria:
• Patient, who is not conform to the study criteria
• Patient with vaginal bleeding
• planned elective C-Section
• acute infection
• no informed consent given by the patient

Algorithm of Gel Application:
Dianatal® Obstetric Gel should be used
•
as described in the product information
(see: special recommodations for use)

CRF (= case record form)
for both Groups:
•
1. all important obstetrical data
2. midwife and patient
evaluate the effect of Dianatal®
by means of a numeric rating scale (= NRS)

Numeric
Rating
Scale (= NRS)
for evaluation
of the effect
of Dianatal®
used by midwives
and patients:
10 points for pain
means much pain,
10 points for
Dianatal® means
very good effect
10 points for delivery
procedure (duration,
feeling well) means
good impression of
Dianatal®

Data of the Perinatal German Statistics:
Germany:
• Prolonged Labor = 9,5%
• delivered by means of
C-section: 64,7%
vaginal-operative: 12,1%
vaginal: 23,2%
Marburg:
• Prolonged Labor = 12,1%
• delivered by means of
C-section : 54,9%
vaginal-operative: 18,2%
vaginal: 26,9%

Marburg Experiences in the field of obstructed labor :
indication for obstructed or delayed delivery: 200
outcome:
22% less operative deliveries with Dianatal®
(total number: 73 control group, 57 treatment group)
Mode of delivery
Treatment
group (n= 100)
Vaginal delivery: 43 (+ 63%) 27
Vaginal operative delivery:
Forceps:
Vacuum extraction:
12: (- 34%)
C-Section: 45 (- 19%) 55
0
12
Control group
(n= 100)
18:
1
17

Marburg Experiences (n= 180) :
100
90
80
70
60
50
40
30
20
10
0
- Gel + Gel
acceptance
friction
course
trauma

Marburg Experiences up to now :
Impressions of Dianatal®:
• The defined goals can be realized
• Loss of friction
• Reduces labor stage 2 significantly
• Reduces perineal tears
Reduction of vaginal-operative deliveries
and C-sections in 22%

Scientific principal results by using Dianatal®
Obstetric Gel up to now:
‣ Reduces adhesive and gliding friction significantly by
50 %
‣ Reduces labor stage 2 significantly by 30 %
‣ Reduces perineal tears ( pelvic floor + perineum risk, e.g.:
birthcanal injuries, incontinence, sexual dysfunction )
‣ Up to now no known side-effects
‣ Reduction of the number of C-sections and vaginaloperative
deliveries (forceps + vacuum): our randomized
study is going on („Works in progress“) concerning the
so-called scientific output

Costs versus Benefit –Analysis:
• Prevention of C-Sections:
Difference of costs (DRG´s) vaginal delivery versus
C-section = 1280 € !
• Dianatal® Obstetric Gel:
= 125 € per patient
If a C-section could be avoided by using Dianatal® :
reduction of an increased morbidity + mortality for
mother + child concerning the following
pregnancies (abruptio placenta, placenta praevia,
uterine rupture etc.)
= reduction of follow-up costs!

Summary:
Last but not least
„ Who greases well, drives well !“
that is to say:
1. If there is enough oil in a motor, the motor runs frictionless
or smooth
and / or:
2. If you pay good for Dianatal®, you will get a good output,
that is to say, a smaller amount of operative deliveries with
high (follow-up) costs
( a tip for the health insurances).
3. Dianatal is a tool to support the salutogenesis of pregnant
women (intention to have vaginal child birth)