Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
Trial Parameters
Brief 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 Criteria
Inclusion Criteria: * Age over 18 years * Singleton gestation, with cephalic presentation * Gestational age at randomization between entre 34 weeks of gestation and 0 day and 41 weeks of gestation and 0 day * Fetal growth restriction (FGR). FGR is defined at the third trimester by an abdominal circumference below the 10th centile and/or an estimated fetal weight below the 10th centile (according to local curve), according to the trial DIGITAT. Fetus with normal and abnormal Doppler index can be included. * Plan for induction of labor whatever the indication (fetal growth restriction or other), the induction of labor is the induction of birth by vaginal delivery * Bishop Score below 6 * Affiliated or beneficiary to a health security system * Signed informed consent Exclusion Criteria: * Contraindication to an induction of labor * History of previous cesarean delivery, myomectomy by laparotomy or laparoscopy * Contraindication to misoprostol or trans-cervical balloon * Known HIV positivi