A Comparison of Balloon Catheter Versus Ocytocin for Cervical Ripening on Scarred Uterus With Unfavorable Cervix
NCT ID: NCT01711060
Last Updated: 2016-10-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
204 participants
INTERVENTIONAL
2010-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Groups
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oxytocin
oxytocin
balloon catheter
Dufour 1859H18
balloon catheter
Interventions
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oxytocin
balloon catheter
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
45 Years
FEMALE
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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Service Gynécologie Obstétrique
Angoulême, , France
Service Gynécologie Obstétrique
Bressuire, , France
Service Gynécologie Obstétrique
Châtellerault, , France
Service Gynécologie Obstétrique
Nancy, , France
Service Gynécologie Obstétrique et médecine de la reproduction
Poitiers, , France
Service Gynécologie Obstétrique
Rennes, , France
Service Gynécologie Obstétrique
Toulouse, , France
Countries
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References
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de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.
Other Identifiers
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CICATAC
Identifier Type: -
Identifier Source: org_study_id
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