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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: French Ministry of Social Affairs and Health
• Treatments: Misoprostol

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 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