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drugset / Trial / NCT06803992

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

NCT06803992 ↗

Phase 4 Recruiting 140 enrolled HaEmek Medical Center, Israel
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-04-06
Primary completion
2027-01-29
Completion
2027-01-29

Drugs

EvaluationDrugModalityDoseRoute
Subject Dinoprostone Other / unclassified 1 mg Other
Subject Dinoprostone Other / unclassified 10 mg Other

Indications

No indication recorded.