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Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
Sponsor: University Hospital, Bordeaux
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
Conditions
Interventions
Trans-cervical balloon
Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).
Misoprostol
Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)
Locations (1)
CHU Bordeaux
Bordeaux, France