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.

Trial Health

On Track

Trial Health Score

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

Enrollment

204

participants targeted

Target at P75+ for not_applicable

Geographic Reach

1 country

7 active sites

Status

completed

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 Start

First participant enrolled

December 1, 2010

Completed

1.7 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed

2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2012

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed

Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

3.1 years

First QC Date

August 23, 2012

Last Update Submit

October 10, 2016

Conditions

Scarred Uterus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

Rate of incidence of materno-fœtales morbidity

Study Arms (2)

oxytocin

EXPERIMENTAL

Drug: oxytocin

balloon catheter

EXPERIMENTAL

Dufour 1859H18

Procedure: balloon catheter

Interventions

oxytocinDRUG

oxytocin

balloon catheterPROCEDURE

balloon catheter

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale

Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.