N. Al-Ibraheem, M. Al-Khateeb, T. Athamneh, Z. Shraideh
N. Al-Ibraheem, M. Al-Khateeb, T. Athamneh, Z. Shraideh
N. Al-Ibraheem, M. Al-Khateeb, T. Athamneh, Z. Shraideh
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A Comparison of Intracervical Foley’s Catheter Versus<br />
Posterior Fornix Prostaglandin E2 for Cervical Ripening<br />
in Post-Date Pregnancy<br />
Nedal <strong>Al</strong>-<strong>Ibraheem</strong> MD*, Mahmood <strong>Al</strong>-<strong>Khateeb</strong> MD*, Tareq <strong>Athamneh</strong> MD*,<br />
Ziad <strong>Shraideh</strong> MD*<br />
ABSTRACT<br />
Objective: To compare the efficiency, safety and side effects of intracervical Foley’s catheter versus<br />
posterior Fornix Prostaglandin E2 for cervical ripening in post-date pregnancy.<br />
Methods: This study was conducted on 200 women at Prince Rashed military hospital in the north of Jordan<br />
between October 2004 and October 2005. A total of 200 women were studied. <strong>Al</strong>l were post-date of at least<br />
one week and in need for induction of labour. They were divided into two groups: the first group consisted of<br />
100 women who underwent pre-induction cervical ripening by intra – cervical Foley’s catheter, while the<br />
second group consisted of 100 women who were induced by posterior Fornix Prostaglandin E2 at six hour<br />
interval.<br />
Results: The efficacy of both methods for pre-induction cervical ripening of labor in post-date pregnancy<br />
were almost the same. Foley’s catheter success rate was slightly higher in primigravidae and it was<br />
inexpensive while PGE2 success rate was almost the same with shorter time for cervical ripening. Both<br />
methods were the same regarding safety and frequency of side effects.<br />
Conclusion: The use of intracervical Foley’s catheter for cervical ripening of labour in post date<br />
pregnancy is safe, effective, and the success rate is comparable with posterior fornix prostaglandin E2.<br />
Key words: Foley’s catheter, Prostaglandin E2, Post-date pregnancy, Cervical ripening<br />
JRMS July 2010; 17(Supp 2): 21-24<br />
Introduction<br />
Post-date pregnancy is defined as pregnancy<br />
extended beyond 40 weeks gestational age. It<br />
accounts for 10% of all pregnancies (1) and is<br />
considered to be a risk factor for both mother and<br />
fetus with increased perinatal mortality, (2) therefore<br />
intervening at the appropriate time is the best<br />
solution. This can be performed by various methods<br />
including the oldest methods (nipple stimulation,<br />
sexual activity, castor oil, enemas, stripping the<br />
membranes, amniotomy, mechanical dilatation by<br />
intracervical Foley’s catheter, posterior fornix<br />
prostaglandin E2 and oral or vaginal PGE1). (3)<br />
Insertion of intracervical Foley’s catheter is at<br />
least as effective as PGE2 in the ripening process,<br />
perhaps even more effective. (4) This process is<br />
critical for successful induction of labor (5) in postdate<br />
pregnancy. The cervix undergoes significant<br />
biochemical changes which are controlled by certain<br />
hormones (in particular PGE2) that play a role in<br />
triggering uterine contractile activity. (6) The ripening<br />
process usually begins prior to onset of labor<br />
contraction and is necessary for cervical dilatation. (6)<br />
*From the Department of Gynecology and Obstetrics, Prince Rashid Ben <strong>Al</strong>-Hassan Hospital (PRHH), Irbid-Jordan<br />
Correspondence should be addressed to Dr. N. <strong>Al</strong>-<strong>Ibraheem</strong> (PRHH), Irbid-Jordan.<br />
Manuscript Received March 13, 2006. Accepted September 30, 2006.<br />
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Vol. 17 Supp No. 2 July 2010<br />
21
Table I. Demographic characteristics of the study groups<br />
Characteristics Group I Group II Significance<br />
Mean Maternal Age (years) 25.3±5.2 27.2±4.5 NS<br />
Mean Gestational Age (weeks) 41.5±0.3 41.2±0.2 NS<br />
Primigravida 50 50 NS<br />
Multigravida 50 50 NS<br />
NS: not significant<br />
Table II. Induction outcomes of the study groups<br />
Outcome Group I Group II Significance<br />
Mean cervical ripening time (hours) 16.2±4.3 14.1±3.5 NS<br />
Number of pregnant women with Bishop Score >7 88 92 NS<br />
Number of primigravida with Bishop Score >7(%) 46(92) 47(94) NS<br />
Number of multigravida with Bishop Score >7(%) 42(84) 45(90) NS<br />
Since post-date pregnancy is one of the commonest<br />
indication for induction of labor (6,7) this process<br />
should be considered when it is felt that the benefits<br />
of vaginal delivery outweigh the potential maternal<br />
and fetal risks of induction. There is clinical<br />
evidence which shows that the appropriate<br />
utilization of mechanical methods for pre-induction<br />
cervical ripening is safe, not expensive, and with a<br />
similar success rate to that of intravaginal PGE2.<br />
The most commonly used mechanical method is the<br />
intracervical Foley’s catheter. (7)<br />
In this study, we compare the efficiency, safety<br />
and side effects of intracervical Foley’s catheter<br />
versus PGE2 suppositories for cervical ripening in<br />
post-date pregnancy.<br />
Methods<br />
This study was conducted on 200 women at Prince<br />
Rashed Military Hospital in the North of Jordan<br />
between October 2004 and October 2005. <strong>Al</strong>l were<br />
post-date of at least one week. This was chosen<br />
since perinatal morbidity and mortality did not<br />
increase appreciably between 40-41 weeks of<br />
gestation, however several complications were<br />
associated with longer gestation. (8)<br />
Women whose fetuses were 41 weeks of<br />
gestational age or above measured according to<br />
accurate last menstrual period and had closed or<br />
nearly closed cervix, excluding those who were<br />
lactating or had contraindications to either Foley’s<br />
catheter (spontaneous rupture of membranes,<br />
antepartum bleeding) and PGE2 (bronchial asthma,<br />
PGE2 allergy) were included in the study. The<br />
pregnant women were divided in two groups.<br />
Group I (n=100) had an intracervical Foley’s<br />
catheter inserted. Group II (n=100) had posterior<br />
fornix PGE2 suppositories inserted six hours apart.<br />
In this study, patients in Group I had an 18 F<br />
balloon – tipped Foley’s catheter inserted through<br />
the cervical canal beyond the internal os under direct<br />
vision using sterile technique (bivalve speculum,<br />
two sponge forceps, Foley’s catheter) after washing<br />
the vagina and vulva with Betadine solution. An<br />
intravenous prophylactic antibiotic was given<br />
(Cephalothin one gram single dose). A Foley’s<br />
catheter was inflated with 50cc of normal saline<br />
solution and placed under traction by fixation to the<br />
patients’ thigh using a cord clamp and adhesive<br />
tape. This would increase the release of<br />
prostaglandin from the cervix. (9) The Foley’s<br />
catheter remained for 24 hours and was deflated<br />
after that if it was not spontaneously expelled. The<br />
pregnant women underwent external fetal heart rate<br />
monitoring for one hour, then were allowed to<br />
ambulate and were monitored regularly.<br />
Women who were subjected to the posterior<br />
fornix PGE2 were given 3mg suppositories six<br />
hours apart over 24 hours for three doses under<br />
aseptic technique and were advised to remain in bed<br />
for at least two hours after each dose with<br />
continuous fetal heart monitoring. Before the next<br />
dose, patients were evaluated for cervical dilatation<br />
and 100mg Pethidine intramuscularly was given<br />
according to the strength of contraction. Pregnant<br />
women who did not have favorable cervix (Bishop<br />
score 7 within 24 hours (10) after which<br />
artificial rupture of membranes was performed and<br />
labor was induced by intravenous Syntocinone<br />
infusion. After a successful trial, pregnant women<br />
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Vol. 17 Supp No. 2 July 2010
Table III. Modified Bishop scores in the study groups<br />
Score Dilatation (cm) Effacement (%) Station ³ Position of cervix<br />
0 Closed 0- 30 -3 Posterior<br />
1 1-2 40- 50 -2 Midposition<br />
2 3-4 60-70 -1-0 Anterior<br />
3 ≥5 ≥ 80 +1-+2 ------<br />
Table IV. Side effects in the study groups<br />
Symptoms Group I Group II Significance<br />
Nausea 1 4 NS<br />
Vomiting 2 3 NS<br />
Diarrhea 1 2 NS<br />
Fever 3 2 NS<br />
Discomfort 3 1 NS<br />
NS: Not significant<br />
were examined for any side effects including<br />
maternal fever, vaginal bleeding, hypertonic uterine<br />
contraction, and nausea and vomiting. P0.5). The number of patients with ripened cervix<br />
was almost similar in both groups (88% versus 92%<br />
respectively) as shown in Table II, ripened cervix<br />
was considered as Bishop score >7, the remaining<br />
patients were given trial of cervical sweeping and<br />
others underwent CS for failed induction.<br />
Side effects like nausea, vomiting, diarrhea and<br />
fever were similar and minimal in both groups<br />
(Table IV). The most common side effect was mild<br />
discomfort during the procedure in the first group<br />
and nausea in the second group, no case of uterine<br />
rupture was recorded, although three cases of<br />
previous scar were included in first group, patients<br />
who were in need for analgesia in form of<br />
intramuscular Pethidine were higher in the second<br />
group. We also found that Foley’s catheters were<br />
cost effective when used for same purpose which is<br />
an important issue in medical therapy for the<br />
patients and medical staff. In our study, the Foley’s<br />
catheter is relatively inexpensive (about 2,5 JD or<br />
3.6 US dollars compared to 20 JD or 28.4 US dollars<br />
for PGE2 suppositories).<br />
The success rate of intracervical Foley’s catheter<br />
was higher in primigravidae in comparison with<br />
multigravidae (92% versus 84%) while it was<br />
almost the same regarding prostaglandin E2 (90%,<br />
94%) respectively as shown in Table II. Most<br />
patients in group II needed at least two PGE2<br />
suppositories.<br />
Discussion<br />
Few previous studies recommended use of Foley’s<br />
catheter with extra-amniotic corticosteroids infusion<br />
to increase its efficacy and shorten inductiondelivery<br />
time. (11) It is generally accepted that<br />
antepartum interventions are indicated in the<br />
management of prolonged pregnancy. (12) This can be<br />
performed by various methods, the most popular are<br />
to use either intracervical Foley’s catheter or PGE2<br />
suppositories, there have been theoretic concern<br />
regarding the introduction of infection with the use<br />
of Foley’s catheter, but this can be ignored by using<br />
aseptic technique as noted by a previous study. (12)<br />
The other concern is uterine hyperstimulation with<br />
the use of PGE2 suppositories which can be<br />
minimized by using continuous fetal heart and<br />
uterine contraction monitoring for at least two hours<br />
after each PGE2 insertion as mentioned previously.<br />
Numerous studies compared these two methods<br />
and proved to be effective. St Onge and Connors<br />
reported that for preinduction cervical ripening there<br />
is no difference in the efficacy between an<br />
intracervical Foley’s catheter and vaginal PGE2<br />
suppositories. (12) <strong>Al</strong> Taani’s study concluded that for<br />
grandmultiparas, PGE2 vaginal tablets may be<br />
JOURNAL OF THE ROYAL MEDICAL SERVICES<br />
Vol. 17 Supp No. 2 July 2010<br />
23
preferable for cervical ripening as well as for labour<br />
induction. (6) In this study, we compared two<br />
methods (intracervical Foley’s catheter versus<br />
posterior fornix PGE2) and found that both methods<br />
were effective, safe, and with less side effects when<br />
used for cervical ripening in post-date pregnancy, a<br />
finding which was supported by other previous and<br />
similar studies. (10,11,12)<br />
The risk of uterine rupture with PGE2 use versus<br />
spontaneous trial was 6.41 (13) and for this reason<br />
women with previous scar were excluded from the<br />
second group while Foley’s catheter can be used<br />
safely in patients with previous scar without risk of<br />
uterine rupture, (14) Some hospitals have discontinued<br />
PGE2 use for all women with previous scar, PGE2<br />
suppositories induce cervical ripening by collagen<br />
breakdown and altering tissue hydration and<br />
collagen binding.<br />
Various studies have shown considerable variation<br />
in induction delivery time ranging from 9-17.9 hours<br />
and the incidence of CS was 16.67%. (14) These were<br />
consistent with our study findings (cervical ripening<br />
time 16.2 hours for group I, 14.1 hours for group II,<br />
incidence of CS 12%, 8% respectively). In our<br />
study, we observed that pregnant women with<br />
Bishop Score 3-4 at beginning of the study respond<br />
better to induction than those with closed thick<br />
cervix and the induction delivery time was shorter.<br />
The complications in our study were minimal and<br />
treated successfully. No uterine rupture or cervical<br />
laceration occurred. Since patients with previous<br />
scar were excluded from the start, both methods of<br />
labor induction in post-date pregnancy were<br />
effective and successful with minimal adverse<br />
effects which were comparable to other<br />
studies. (12,13,14)<br />
We conclude that intracervical Foley’s catheter<br />
for labor induction in post-date pregnancy,<br />
particularly in primigravida and patients with<br />
previous scar, is a reasonable alternative to PGE2<br />
suppositories, is reversible, easy to use, costeffective<br />
and has minimal adverse effects.<br />
References<br />
1. Harman JH, Kim A. Current Trends in cervical<br />
ripening and labor induction. Am Academy of<br />
family physician 1999; 60: 477- 484.<br />
2. Cunninham FG, MacDonald PC, Gant NF,<br />
Leveno KJ, et al. Williams obstetrics textbook,<br />
20 th edition, 1997; P. 430,827-837.<br />
3. Crane J, St. Johns NF. SOGC clinical practice<br />
guidelines, Induction of labour at term. J obstet .<br />
gynaecol Can 2001; 23(8): 717-728.<br />
4. Chamberlain G, Zonder L. Major indication for<br />
induction of labour. BMJ 1999; 318(7): 995-998.<br />
5. Khadem N, Khadivzadeh N. Comparison of the<br />
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Iran J Med Sci 2003; 28(3): 119-122.<br />
6. <strong>Al</strong>-Taani MI. Comparison of PGE2 tablets or<br />
Foley catheter for labor induction in grand<br />
multiparas. Eastern Mediterranean Health J 2004;<br />
10(4): 547-553.<br />
7. Ghezzi F, Massimo F, Raio L, et al. Extraamniotic<br />
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Medica Iranica 2004; 42(5): 338-342.<br />
12. St Onge RD, Connors GT. Preinduction cervical<br />
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J Obstetric and Gynecology 1995; 172(2): 687–<br />
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2000; 2(182): 36-43.<br />
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2004; 103: 18-23.<br />
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