Comparing two methods for inducing labor in pregnancies with fetal growth restriction
Prostaglandins Versus Trans-Cervical Balloon for Induction of Labor in Fetal Growth Restriction: a Multicenter Open-label Randomized Trial
NA · University Hospital, Bordeaux · NCT05674487
This study is testing whether using a balloon to help start labor is better than using medication for women with babies that aren't growing well, to see if it leads to fewer C-sections and healthier babies.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 774 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05674487 on ClinicalTrials.gov |
What this trial studies
This randomized trial aims to compare the effectiveness of two cervical ripening methods, trans-cervical balloon and prostaglandins, in women with fetal growth restriction. The primary objective is to determine whether the trans-cervical balloon method results in a lower cesarean section rate without increasing neonatal morbidity. Participants will be randomly assigned to receive either the trans-cervical balloon or prostaglandins for labor induction. The study addresses a significant gap in current guidelines regarding the optimal induction method for this high-risk population.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women over 18 years old with singleton gestation and fetal growth restriction, indicated by specific ultrasound measurements.
Not a fit: Patients who have contraindications to labor induction or a history of previous cesarean deliveries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer labor induction practices for women with fetal growth restriction, potentially reducing cesarean delivery rates and improving neonatal outcomes.
How similar studies have performed: While some retrospective studies suggest advantages of the trans-cervical balloon over prostaglandins, this trial is among the first to rigorously compare these methods in the context of fetal growth restriction.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux
- CHU Bordeaux — Bordeaux, France (RECRUITING)
Study contacts
- Study coordinator: Hanane Bouchghoul, MD
- Email: hanane.bouchghoul@chu-bordeaux.fr
- Phone: +335 57 82 16 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fetal Growth Restriction, Fetal growth restriction, Cesarean section, Induction of labor, Cervical ripening, Neonatal morbidity