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

What this Trial Is About

This research aims to compare two methods of inducing labor in pregnant women with fetal growth restriction (FGR), a condition linked to higher risks for the baby around birth. The study focuses on whether using a trans-cervical balloon for cervical ripening reduces the rate of cesarean sections without increasing health problems for the newborn, compared to prostaglandins (specifically Misoprostol). There is currently no clear guidance on the best induction method for pregnancies complicated by FGR, and this trial seeks to provide high-quality evidence to inform future recommendations. Participants will be randomly assigned to one of two groups: one will receive labor induction using a trans-cervical balloon catheter, a mechanical method to prepare the cervix, while the other group will receive prostaglandins orally (Misoprostol), a drug-based method. Both approaches are used when the cervix is not yet favorable for labor (Bishop score below 6). The study will take place during late pregnancy from 34 to 41 weeks of gestation, focusing on pregnancies with confirmed FGR. During the study, participants will be monitored closely through labor and delivery, with researchers evaluating the rate of cesarean sections as the primary outcome on the day of birth. Additional assessments will include labor duration, use of oxytocin, postpartum bleeding, infections, neonatal health measures like Apgar scores and intensive care needs, and maternal wellbeing including postpartum depression and stress up to two months after delivery. The study aims to provide comprehensive data on the safety and effects of both induction methods for mothers and babies.

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