NCT05674487 Prostaglandins Versus Trans-cervical Balloon for Induction of Labor in Fetal Growth Restriction (PROBIN)
| NCT ID | NCT05674487 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Fetal Growth Restriction |
| Study Type | INTERVENTIONAL |
| Enrollment | 774 participants |
| Start Date | 2024-04-09 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 774 participants in total. It began in 2024-04-09 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05674487 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fetal Growth Restriction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05674487 currently recruiting?
Yes, NCT05674487 is actively recruiting participants. Contact the research team at hanane.bouchghoul@chu-bordeaux.fr for enrollment information.
Where is the NCT05674487 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT05674487 clinical trial?
NCT05674487 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 774 participants.