NCT05674487

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
774

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

December 30, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 6, 2023

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 9, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

December 30, 2022

Last Update Submit

March 28, 2025

Conditions

Fetal Growth Restriction

Keywords

Fetal growth restrictionCesarean sectionInduction of laborCervical ripeningNeonatal morbidity

Outcome Measures

Primary Outcomes (1)

  • cesarean section

    Incidence of cesarean section defined as a cesarean birth regardless of the indication

    Day 1

Secondary Outcomes (32)

  • duration of labor

    Day 1

  • duration between cervical ripening and delivery

    Day 1

  • oxytocin use

    Day 1

  • operative delivery

    Day 1

  • postpartum hemorrhage

    Day 3

  • +27 more secondary outcomes

Study Arms (2)

Trans-cervical balloon

EXPERIMENTAL

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

Device: Trans-cervical balloon

Misoprostol

ACTIVE COMPARATOR

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

Drug: Misoprostol

Interventions

Trans-cervical balloonDEVICE

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

Trans-cervical balloon
MisoprostolDRUG

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

Misoprostol

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

Hanane Bouchghoul, MD

CONTACT

+335 57 82 16 12hanane.bouchghoul@chu-bordeaux.fr

Loic Sentilhes, MD, PhD

CONTACT

loic.sentilhes@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2022

First Posted

January 6, 2023

Study Start

April 9, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)