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

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 29, 2025 to Apr 6, 2025
    • Site details revised
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06803992
Lead Sponsor HaEmek Medical Center, Israel
Conditions
(from sponsor)		 Induction of Labor
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov