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Clinical Trials in France / NCT05674487
Recruiting Not applicable

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

NCT05674487 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Bordeaux
Phase
Not applicable
Started
2024-04-09
Last updated
2025-04-02

Condition(s) studied

Fetal Growth Restriction

Investigational drug(s) / intervention(s)

Trans-cervical balloonMisoprostol →

Trans-cervical balloon: Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).

Misoprostol: Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)

Study 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

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • cesarean section — Day 1
    Incidence of cesarean section defined as a cesarean birth regardless of the indication

Trial sites (1)

FacilityCityRegionStatus
CHU Bordeaux Bordeaux France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05674487 on ClinicalTrials.gov ↗ ← All trials in France