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

Launched by UNIVERSITY HOSPITAL, BORDEAUX · Apr 27, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at two different methods to help start labor in pregnant women whose babies are not growing as expected, a condition known as fetal growth restriction (FGR). The main question the researchers want to answer is whether using a trans-cervical balloon is better than prostaglandins (a type of medication) for reducing the chances of needing a cesarean section (C-section) while also keeping the baby safe. Participants in the study will be randomly assigned to one of the two methods: either the trans-cervical balloon or prostaglandins.

To be eligible for this trial, women need to be over 18 years old, pregnant with one baby, and at least 34 weeks along but not more than 41 weeks. They should also have a specific diagnosis of fetal growth restriction. Additionally, they need to have a score indicating that their cervix is not yet ready for labor. Women with a history of certain surgeries, some medical conditions, or those who do not understand French will not be able to participate. If you join this trial, you can expect to receive either the balloon or medication to help start labor, and the study aims to find out which method works better for both mothers and their babies.

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