Overview

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