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RECRUITING
NCT05674487
NA

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

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

774

Start Date

2024-04-09

Completion Date

2026-12-01

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

DEVICE

Trans-cervical balloon

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

DRUG

Misoprostol

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

Locations (1)

CHU Bordeaux

Bordeaux, France