A randomized clinical trial of PGE2 pessaries and
a slow release dinoprostone vaginal insert for labor induction
S. AlBasri, H. Nasrat
OB/GYN,KAAUH-JEDDAH-S.A.
Objective: to compare the efficacy of tow different PGE2 delivery methods for
induction of labor .
Study Design: 50 patients required induction of labor were allocated randomly to receive
either PGE2 (prostin) or dianoprosone (propess).
Results:
Conclusion:
Key words: induction of labor, prostaglandin.
Introduction
Induction of labor refers to the initiation of uterine contractions before the spontaneous
onset of labor by medical and / or surgical means for the purpose of delivery. (1)
In general, induction of labor is indicated when the benefit of delivery to mother and/or
fetus outweigh the potential risks of continuing the pregnancy.
An unfavorable cervix is a well recognized impediment to successful induction of
labor.(2)
Approximately 20-30% of all pregnant women are induced .(3)
Prostaglandins E2 (PGE2) preparations have gained wide acceptance for ripening the
cervix .
A change in cervical score and the interval from induction to active labor have been used
to compare the effectiveness of different forms of these medications.
Since early 1970, PGE2 has been used successfully for this purpose.
PG are family of 20-carbone bioactive lipids.
In 1995 FDA approved the use of a sustain release vaginal insert containing
dinoprostone.
The tow agents differ in dosing and application.
Propess is a vaginal pessary that contains 10 mg of PGE2 released at rate of 0.3 mg / hr
over 12 hrs.
The purpose of this study was to compare the efficacy and safety of propess with the
prostin for cervical ripening and labor induction.
Method
Any women requiring induction of labor for medical or obstetric reasons at KAAUH was
evaluated for study entry.
Inclusion criteria were:1) singleton fetus in cephalic presentation. 2)term gestation.
3)Bishop score < or = 6. 4) intact membrane. 5)normal non stress test.
Exclusion criteria were: 1) surgically scared uterus 2) abnormal placenta.
The study protocol was approved by research ethical committee of the hospital .
Informed consent was obtained .
Randomization was performed using closed envelopes to either PGE2 or Propess.
Bishop score is recorded initially.
PGE2 3mg vaginal pessary is inserted in the posterior fornix . a repeat dose was given
every 6hr and maximum 4 doses in 24hrs unless patient started labor or fetal heart was
not reassuring or uterine tachesystole occurred.
Propess 10mg controlled release vaginal pessary is placed in the posterior fornix and
removed after 12hrs. second dose can be placed and maximum tow in 24hrs unless
patient started labor or membranes ruptured or fetal heart was non reassuring or uterine
tachesystole occurred.
One hour after treatment use fetal heart was recorded for one hour.
Intra partum continuous fetal heart monitoring was used.
Artificial rupture of membrane and augmentation by oxytocin were left for decision of
obstetrician taking care of patient during labor and following policy and procedure of the
department.
Maternal demographic data are recorded: nationality (Saudi or non Saudi), age, gravidity,
parity, gestational age, weight, and indication for induction.
Neonatal birth weight and Apgar score at1 and 5 were recorded.
The primary outcome was the percent of patient delivered vaginally within 24 hrs from
start of induction.
Secondary outcomes was the rate of cesarean section
Results
Demographic characteristics
PGE2 Propess
Age
Nationality
Gravidity
Parity
Gestational age
Maternal weight
Bishop score
Indication for induction
PGE2 Propess
Post date
Oligohydramios
IUGR
Diabetes
Hypertension
Others
Time intervals from start of induction
to vaginal delivery
PGE2 Propess
To active labor
To augment
To fully dilation
To deliver
Indication for cesarean section
PGE2 Propess
Failure to progress
Fetal distress
Malpresentation
Neonatal outcome
Birth weight (kg)
PGE2 Propess Statistical significance
P=
Apgar @ 1 (mean)
Apgar @ 5 (mean)
P=
P=
Comments and Discussion
The strength of this study was in its randomized design, but its small number …..
Both methods appear safe and acceptable for patients
Bishop score assessment is some what subjective
Propess has better acceptance and use