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

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.

Timeline

Start

2024-04-09

Primary completion

2026-12-01

Completion

2026-12-01

Publications

• Bouchghoul H, Madar H, Froeliger A, Lacoste C, Kret M, Benard A, Sentilhes L; PROBIN study group. Prostaglandins versus transcervical balloon for induction of labor for fetal growth restriction: study protocol for a randomized, multicenter, open-label, superiority trial (PROBIN). BMC Pregnancy Childbirth. 2026 Feb 9;26(1):270. doi: 10.1186/s12884-026-08709-x.

Drugs

Indications