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

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.

Inclusion Criteria:Age over 18 yearsSingleton gestation, with cephalic presentationGestational age at randomization between entre 34 weeks of gestation and 0 day and 41 weeks of gestation and 0 dayFetal 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 deliveryBishop Score below 6Affiliated or beneficiary to a health security systemSigned informed consentExclusion Criteria:Contraindication to an induction of laborHistory of previous cesarean delivery, myomectomy by laparotomy or laparoscopyContraindication to misoprostol or trans-cervical balloonKnown HIV positivity (because of modified delivery plan)Known major fetal anomaly or chromosomic anomalyFetal demisePatient under legal protectionPoor understanding of the French language