A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix

October 10, 2016 updated by: Poitiers University Hospital

Increasing cesarean rate in France is worrying. Different methods are described for ripening labor : the use of prostaglandins is described but maybe dangerous for patients with scarred uterus and is not recommended.

Intracervical balloon is an efficient alternative methods which as already been tested for unfavorable cervix ripening on nulliparous women.

But it was rarely tested on women with scared uterus and unfavorable cervix (bishop score <4).

The investigators propose a prospective randomised trial comparing cervix ripening with intracervical balloon inflated by 50 ml sterile water during 12 hours versus ocytocin (reference method).

The investigators expect to demonstrate what it's a safe method to increase vaginal delivery for women with previous cesarean section who need an induction of labour.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angouleme, France
        • Service Gynécologie Obstétrique
      • Bressuire, France
        • Service Gynécologie Obstétrique
      • Chatellerault, France
        • Service Gynécologie Obstétrique
      • Nancy, France
        • Service Gynécologie Obstétrique
      • Poitiers, France, 86021
        • Service Gynécologie Obstétrique et médecine de la reproduction
      • Rennes, France
        • Service Gynécologie Obstétrique
      • Toulouse, France
        • Service Gynécologie Obstétrique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnancy over 37 weeks
  • Singleton pregnancy
  • Vertex presentation
  • Previous caesarean section with unique Transversal segmentary incision
  • Medical indication of induction of labor
  • Unfavorable cervix with Bishop score < 4
  • No Premature Rupture Of Membranes
  • Informed consent

Exclusion Criteria:

  • Before 18 years old
  • Placenta Praevia
  • Premature Rupture Of Membranes
  • Uterine scar other than transversal segmentary incision
  • Cervical infection (except Streptoccoccus Agalactiae carrier) or choriamnionitis
  • Multiple pregnancy
  • Fetal malpresentation
  • Cesarean indication
  • Latex allergy
  • No informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: oxytocin
Drug: oxytocin
EXPERIMENTAL: balloon catheter
Dufour 1859H18
Procedure: balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Rate of childbirth by low way
The childbirth by low way being considered as a success of the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Rate of incidence of materno-fœtales morbidity
number

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (ESTIMATE)

October 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CICATAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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