NCT06803992

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

Induction of Labor in Women With Unfavorable Cervix at Term - Comparison of Propess Versus Prostaglandin E2 Vaginal Gel and Extra-amniotic Balloon Catheter

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Induction of Labor

Interventions

Type	Name	Description
DRUG	Dinoprostone vaginal insert	Described in the arm descriptions
COMBINATION_PRODUCT	Dinoprostone gel and Foley catheter balloon	Described in the arm descriptions

Timeline

• Start date: 2025-04-06
• Primary completion: 2027-01-29
• Completion: 2027-01-29
• First posted: 2025-01-31
• Last updated: 2025-12-01

Locations

1 site across 1 country: Israel