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

NCT06803992 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-12-01

No results posted yet for this study

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

DRUG

Dinoprostone vaginal insert

Described in the arm descriptions

COMBINATION_PRODUCT

Dinoprostone gel and Foley catheter balloon

Described in the arm descriptions

Sponsors & Collaborators

  • HaEmek Medical Center, Israel

    lead OTHER

Principal Investigators

  • Zohar Nachum, Professor · Emek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06803992 on ClinicalTrials.gov