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RECRUITING
NCT06803992
PHASE4

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

Sponsor: HaEmek Medical Center, Israel

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-04-06

Completion Date

2027-01-29

Last Updated

2025-12-01

Healthy Volunteers

No

Interventions

DRUG

Dinoprostone vaginal insert

Described in the arm descriptions

COMBINATION_PRODUCT

Dinoprostone gel and Foley catheter balloon

Described in the arm descriptions

Locations (1)

Emek medical center

Afula, Israel