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

NCT05674487 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 774

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

  • Fetal Growth Restriction

Interventions

DEVICE

Trans-cervical balloon

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

DRUG

Misoprostol

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

Sponsors & Collaborators

  • French Ministry of Social Affairs and Health

    collaborator UNKNOWN

  • University Hospital, Bordeaux

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-09
Primary Completion
2026-12-01
Completion
2026-12-01

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05674487 on ClinicalTrials.gov