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

Not Applicable

Completed

• Conditions: Scarred Uterus
• Interventions: Drug: oxytocin; Procedure: balloon catheter

• Registration Number: NCT01711060
• Lead Sponsor: Poitiers University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-22
• Primary Completion: 2014-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-10
• Last Update Posted: 2016-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 204

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oxytocin	oxytocin	-
balloon catheter	balloon catheter	Dufour 1859H18

Primary Outcome Measures

Name	Time	Method
Rate of childbirth by low way		The childbirth by low way being considered as a success of the treatment

Secondary Outcome Measures

Name	Time	Method
Rate of incidence of materno-fœtales morbidity		number

Trial Locations

Locations (2)

Service Gynécologie Obstétrique; 🇫🇷 Toulouse, France

Service Gynécologie Obstétrique et médecine de la reproduction; 🇫🇷 Poitiers, France