Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
Prostaglandins Versus Trans-Cervical Balloon for Induction of Labor in Fetal Growth Restriction: a Multicenter Open-label Randomized Trial
University Hospital, Bordeaux
774 participants
Apr 9, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria8
- 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)
- Known major fetal anomaly or chromosomic anomaly
- Fetal demise
- Patient under legal protection
- Poor understanding of the French language
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Interventions
Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).
Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)
Locations(1)
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NCT05674487