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

RecruitingNAAges 18 Years - anyFemaleUniversity Hospital, Bordeaux
NCT05674487 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Trans-cervical balloon
  • Misoprostol
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Where

1 site
CHU Bordeaux
Bordeaux, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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