NCT01711060

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

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

Type	Name	Description
DRUG	oxytocin
PROCEDURE	balloon catheter

Timeline

• Start date: 2010-12-01
• Primary completion: 2014-01-01
• First posted: 2012-10-22
• Last updated: 2016-10-11

Locations

7 sites across 1 country: France