A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
Primary Purpose
Scarred Uterus
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
oxytocin
balloon catheter
Sponsored by
About this trial
This is an interventional trial for Scarred Uterus
Eligibility Criteria
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
Sites / Locations
- Service Gynécologie Obstétrique
- Service Gynécologie Obstétrique
- Service Gynécologie Obstétrique
- Service Gynécologie Obstétrique
- Service Gynécologie Obstétrique et médecine de la reproduction
- Service Gynécologie Obstétrique
- Service Gynécologie Obstétrique
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
oxytocin
balloon catheter
Arm Description
Dufour 1859H18
Outcomes
Primary Outcome Measures
Rate of childbirth by low way
The childbirth by low way being considered as a success of the treatment
Secondary Outcome Measures
Rate of incidence of materno-fœtales morbidity
number
Full Information
NCT ID
NCT01711060
First Posted
August 23, 2012
Last Updated
October 10, 2016
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01711060
Brief Title
A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scarred Uterus
7. Study Design
Study Phase
Not Applicable
Enrollment
204 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oxytocin
Arm Type
Experimental
Arm Title
balloon catheter
Arm Type
Experimental
Arm Description
Dufour 1859H18
Intervention Type
Drug
Intervention Name(s)
oxytocin
Intervention Type
Procedure
Intervention Name(s)
balloon catheter
Primary Outcome Measure Information:
Title
Rate of childbirth by low way
Description
The childbirth by low way being considered as a success of the treatment
Secondary Outcome Measure Information:
Title
Rate of incidence of materno-fœtales morbidity
Description
number
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Eligibility Criteria
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
Facility Information:
Facility Name
Service Gynécologie Obstétrique
City
Angouleme
Country
France
Facility Name
Service Gynécologie Obstétrique
City
Bressuire
Country
France
Facility Name
Service Gynécologie Obstétrique
City
Chatellerault
Country
France
Facility Name
Service Gynécologie Obstétrique
City
Nancy
Country
France
Facility Name
Service Gynécologie Obstétrique et médecine de la reproduction
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
Service Gynécologie Obstétrique
City
Rennes
Country
France
Facility Name
Service Gynécologie Obstétrique
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
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