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

NCT ID: NCT05674487

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 774 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-09
• Study Completion Date: 2026-12-01

Brief Summary

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.

Detailed Description

Fetal growth restriction (FGR) is associated with increased perinatal morbidity and mortality in late pregnancy. Because of this higher risk of adverse perinatal outcome, induction of labor is often proposed and require cervical ripening when the cervix is not favorable, i.e. Bishop score less than 6. Two methods of cervical ripening are currently available and used: pharmacological (prostaglandins) and mechanical (trans-cervical balloon).

Growth-restricted fetuses are a population at increased risk for non-reassuring fetal status and hypoxia during labor because of their lower weight. Prostaglandins can lead to cardiotocograph (CTG) tracing abnormalities by causing uterine tachysystole in normal-weight fetuses. Nevertheless, the question of the method of induction of labor has been poorly studied in the population of growth-restricted fetuses. None of the national and international societies reports in their guidelines which method of induction of labor should be offered to pregnancies complicated by a fetal growth restriction. A few retrospective studies are in favor of an increased risk of uterine tachysystole with consequences on the CTG tracing in the case of cervical ripening with prostaglandins compared to the trans-cervical balloon. However, the results of these studies lack robustness due to important methodological limitations.

Because trans-cervical balloon is a mechanical method of cervical ripening, it may be less likely to cause uterine tachysystole and thus fewer non-reassuring fetal status. Thus, the risk of cesarean section in labor could be decreased compared with the use of prostaglandins in the growth-restricted fetal population.

To date, there is no published quality randomized controlled trials on the optimal method of cervical ripening in induction of labor for FGR fetuses.

The present large-scale randomized trial aim to define the preferred method of induction for these fetuses, associated with a lower risk of cesarean delivery. If it is demonstrated that one method of induction (trans-cervical balloon) is superior to another (prostaglandins) in reducing the cesarean section rate, without increasing neonatal morbidity, the results of our study are likely to lead to changes in national and international recommendations.

Conditions

Fetal Growth Restriction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trans-cervical balloon

Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).

Group Type: EXPERIMENTAL

Trans-cervical balloon

Intervention Type: DEVICE

Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).

Misoprostol

Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)

Interventions

Trans-cervical balloon

Induction of labor by cervical ripening with trans-cervical balloon (Foley catheter).

Intervention Type: DEVICE

Misoprostol

Induction of labor by cervical ripening with Prostaglandins (Misoprostol per os)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

French Ministry of Social Affairs and Health

UNKNOWN

Sponsor Role: collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Bordeaux

Bordeaux, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Hanane Bouchghoul, MD

Role: CONTACT

hanane.bouchghoul@chu-bordeaux.fr

+335 57 82 16 12

Loic Sentilhes, MD, PhD

Role: CONTACT

loic.sentilhes@chu-bordeaux.fr

Facility Contacts

Hanane Bouchghoul, MD

Role: primary

hanane.bouchghoul@chu-bordeaux.fr

+335 56 79 55 79

Other Identifiers

CHUBX 2022/42

Identifier Type: -

Identifier Source: org_study_id

NCT05848869

Identifier Type: -

Identifier Source: nct_alias