One of every four births in the Western world is induced, usually due to the risk of maternal and fetal morbidity. There are several methods of labor induction, pharmacological and mechanical. In cases of unfavorable cervix (Bishop score is below 5), cervical ripening can be induced by either prostaglandins E2 (slow release 10 mg dinoprostone insert (propess) or vaginal gel 1-2 mg) or mechanically by Foley catheter balloon (FCB).
The efficacy of labor induction of propess versus vaginal gel combined with FCB was not studied previously.
The goal of this randomized controlled trial is to compare the efficacy of propess versus PGE2 vaginal gel combined with FCB in women with singletons undergoing labor induction at term. The main question it aims to answer is to compare the time from the beginning of labor induction until delivery.
Pregnant women at term (37 weeks of gestation or more) with singleton
pregnancies that are intended for IOL.
Initial bishop score <5
No contraindications to receive either treatment.
Women with a known hypersensitivity or contraindications to Propess / PGE2.
Parity 5 or more
Labor contractions more than 4 in 20 min
Glaucoma
Parallel
Dinoprostone vaginal insert
DrugDescribed in the arm descriptions
Dinoprostone gel and Foley catheter balloon
Combination productDescribed in the arm descriptions
comparing the duration of induction-to-vaginal delivery
measuring the duration of Induction-of-labor by Propess versus the combined use of PGE2 gel and balloon catheter by induction-to-vaginal delivery interval from the beginning of the induction according to the chosen patient protocol and until vaginal delivery.
rate of vaginal delivery in 24 and 48 hours from IOL
the number of participants who had vaginal delivery in 24 and 48 hours from the beginning of the induction-of-labor for both protocols
Number of Participants with Treatment-Related Adverse Events
Maternal -gathering the numbers of participants who had adverse events such as chorioamnionitis, endometritis, postpartum hemorrhage, uterine rupture, Neonatal -gathering the numbers of participants who had adverse events such as uterine hypertonia (contractions exceeding more than two minutes in duration) and/or tachysystole (more than 5 contractions in 10 minutes, averaged over a 30-minute period) with and without decelerations, non-reassuring fetal heart rate according to fetal monitoring, meconium-stained amniotic liquor, umbilical artery pH less than 7.1, Apgar score less than 7 at 5 min, postpartum transfer to neonatal intensive care unit, infection of the newborn
rate of Induction success
the number of participants who had ceasarean section
rate o Cervical ripening success
the duration from the beginning of the induction to bishop score 5
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