Clinical Trial

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

Recruiting Phase 4
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-28.
Status change: Not Yet Recruiting → Recruiting 2025-11-24
Trial Details
NCT Number NCT06803992
Lead Sponsor HaEmek Medical Center, Israel
Conditions Induction of Labor
Enrollment 140 participants
Start Date 2025-04-06
Primary Completion 2027-01-29 (estimated)
Study Completion 2027-01-29 (estimated)
Updated on ClinicalTrials.gov 2025-12-01