Actively Recruiting

Phase 4
Age: 18Years - 60Years
FEMALE
NCT06803992

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

Led by HaEmek Medical Center, Israel · Updated on 2025-12-01

140

Participants Needed

1

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women at term (37 weeks of gestation or more) with a single baby
  • Intended for labor induction
  • Initial Bishop score less than 5
  • No contraindications to receive either treatment
  • Women willing to give informed consent
  • Women aged 18 years or older
Not Eligible

You will not qualify if you...

  • Known allergy or contraindications to Propess or prostaglandin E2
  • Five or more previous births (parity 5 or more)
  • Labor contractions more than 4 in 20 minutes
  • Glaucoma
  • History of previous uterine surgery
  • Vaginal delivery contraindicated
  • Active heart, kidney, lung, or liver disease
  • Severe asthma or lung disease

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Emek medical center

Afula, Israel

Actively Recruiting

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Research Team

Z

Zohar Nachum, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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