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

NCT01711060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2016-10-11

No results posted yet for this study

Summary

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.

Conditions

  • Scarred Uterus

Interventions

DRUG

oxytocin

PROCEDURE

balloon catheter

Sponsors & Collaborators

  • Poitiers University Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-01-31

Countries

  • France

Study Locations

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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 NCT01711060 on ClinicalTrials.gov