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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Dec 30, 2022

Keywords

ClinConnect Summary

The PROBIN trial is studying two different methods to help women with fetal growth restriction (FGR) start labor safely. FGR means that the baby is not growing as well as expected during pregnancy. The trial compares using a trans-cervical balloon, which is a device placed in the cervix to help it open, against a medication called prostaglandins, specifically Misoprostol, to see which method leads to fewer cesarean deliveries while keeping babies healthy.

To participate in this trial, women must be over 18 years old, be pregnant with a single baby that is positioned head-down, and have a gestational age between 34 and 41 weeks. They should also have a Bishop Score below 6, which is a way to assess how ready the cervix is for labor. Participants can expect to be randomly assigned to one of the two methods of induction and will be carefully monitored throughout the process. This trial is currently recruiting participants, and it’s important to note that certain medical conditions or previous surgeries may prevent someone from taking part.

Gender

FEMALE

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