Actively Recruiting
Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
Led by University Hospital, Bordeaux · Updated on 2025-04-02
774
Participants Needed
1
Research Sites
138 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Bordeaux
Lead Sponsor
F
French Ministry of Social Affairs and Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Singleton gestation with cephalic (head-down) presentation
- Gestational age between 34 weeks 0 days and 41 weeks 0 days at randomization
- Fetal growth restriction defined by abdominal circumference or estimated fetal weight below the 10th percentile
- Plan for induction of labor by vaginal delivery
- Bishop score below 6
- Affiliated or beneficiary to a health security system
- Signed informed consent
You will not qualify if you...
- Contraindication to induction of labor
- History of previous cesarean delivery or myomectomy by laparotomy or laparoscopy
- Contraindication to misoprostol or trans-cervical balloon
- Known HIV positivity
- Known major fetal anomaly or chromosomal anomaly
- Fetal demise
- Patient under legal protection
- Poor understanding of the French language
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHU Bordeaux
Bordeaux, France
Actively Recruiting
Research Team
H
Hanane Bouchghoul, MD
CONTACT
L
Loic Sentilhes, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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