Comparing two methods for inducing labor in pregnancies with fetal growth restriction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• CHU Bordeaux
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Hanane Bouchghoul, MD
• Email: hanane.bouchghoul@chu-bordeaux.fr
• Phone: +335 57 82 16 12

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fetal Heart Function in Growth-Restricted Pregnancies

  This study tests whether fetal echocardiography using a modified Tei index (Mod-MPI) can reveal early heart changes in pregnancies affected by fetal growth restriction (IUGR).

  Recruiting Assiut University · Asyut · NCT07760194

• Combined first-trimester screening for pregnancy complications

  This project tests a standardized first-trimester screening to see if it can identify pregnant women at 11–13 weeks who are at higher risk for preeclampsia, fetal growth restriction, chromosomal problems, and other serious complications.

  Recruiting at 3 sites Institute of Health Information and Statistics of the Czech Republic · Most, Czechia and 2 other locations · NCT07015203

• Left-side positioning for pregnancies with fetal growth restriction

  This trial tests whether pregnant people with fetal growth restriction who lie on their left side for several hours a day help their baby grow better and affect maternal and fetal health measures.

  Recruiting at 2 sites University of Colorado, Denver · Aurora, Colorado and 1 other locations · NCT06919692

• Examining placental blood flow using contrast ultrasound in pregnancies with growth restriction

  This study is testing how well blood flows in the placenta of women having a medical termination of pregnancy, comparing those with and without fetal growth restriction to learn more about these conditions.

  Recruiting Phase 3 Central Hospital, Nancy, France · Nancy · NCT06497959

• L-citrulline supplementation during pregnancy to reduce adverse birth outcomes in Kenyan women at risk of malaria.

  This trial will test whether taking a twice-daily L-citrulline supplement during pregnancy helps Kenyan women at risk of malaria have healthier pregnancies and babies.

  Recruiting Liverpool School of Tropical Medicine · Kisumu · NCT05934318

• Using echocardiography to diagnose fetal growth issues in twin pregnancies

  This study is testing if a special heart ultrasound can help doctors spot growth problems in twins before they are born, while also looking at how air pollution might affect their health.

  Recruiting University Hospital, Ghent · Ghent and 2 other locations · NCT05423665

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.