RecruitingNot ApplicableNCT05674487

Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)

Prostaglandins Versus Trans-Cervical Balloon for Induction of Labor in Fetal Growth Restriction: a Multicenter Open-label Randomized Trial


Sponsor

University Hospital, Bordeaux

Enrollment

774 participants

Start Date

Apr 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this randomized trial is to compare two methods of induction in a fetal growth restriction population. The main question it aims to answer is: • Is trans-cervical balloon superior to prostaglandins in reducing the cesarean section rate, without increasing neonatal morbidity? Participants will have an induction of labour by cervical ripening with trans-cervical balloon in the trans-cervical balloon catheter arm and with Prostaglandins in the Misoprostol arm. Researchers will compare two methods of induction: trans-cervical balloon and prostaglandins to see if trans-cervical balloon is associated with a lower risk of cesarean delivery.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Misoprostol and a medical device called Trans-cervical balloon for people with fetal growth restriction. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETrans-cervical balloon

Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).

DRUGMisoprostol

Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)


Locations(1)

CHU Bordeaux

Bordeaux, France

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NCT05674487


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