Induction of Labor - Comparison Propess With Prostaglandin E2 Vaginal Gel and Balloon Catheter

Recruiting now · Phase 4

Conditions studied: Induction of Labor

In brief

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.

Key facts

Study ID: NCT06803992
Run by: HaEmek Medical Center, Israel
People needed: 140
Starts: 2025-04-06
Expected to finish: 2027-01-29
Last updated by the study team: 2025-12-01

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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 who will give informed consent to be included in the study.
Women at or over the age of 18.

You may not qualify if…

Women with a known hypersensitivity or contraindications to Propess / PGE2.
Parity 5 or more
Labor contractions more than 4 in 20 min
Glaucoma
History of previous uterine surgery
Hypersensitivity to prostaglandins
Vaginal delivery is contraindicated
Active cardiac, renal, pulmonary, or hepatic disease
Severe asthma or pulmonary disease

Where it is running

Emek medical center — Afula, Israel (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.