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.
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.
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 positivity (because of modified delivery plan)
Parallel
Trans-cervical balloon
DeviceInduction of labor by cervical ripening with trans-cervical balloon (Foley catheter).
Misoprostol
DrugInduction of labor by cervical ripening with Prostaglandins (Misoprostol per os)
cesarean section
Incidence of cesarean section defined as a cesarean birth regardless of the indication
duration of labor
Mean duration of labor (duration between admission to the labor room and delivery)
duration between cervical ripening and delivery
Mean duration between cervical ripening and delivery
oxytocin use
Incidence of oxytocin use (median of the maximal administered dosage)
operative delivery
Incidence of operative delivery (vacuum, forceps, spatula)
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University Hospital, Bordeaux
Lead sponsor
French Ministry of Social Affairs and Health
Collaborator
