Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
NCT ID: NCT01091285
Last Updated: 2011-08-17
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
PHASE4
180 participants
INTERVENTIONAL
2010-03-31
2011-01-31
Brief Summary
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160 women with singleton term pregnancies with un ripe cervix and no contraindications for catheters will be included and randomized to either double og single balloon catheters for cervical ripening. Efficacy wil be assessed at removal of the catheter, measured by the amount of women where the cervix has become ripe enough for amniotomy.
Our hypothesis is that double balloon catheters will give a greater amount of women where amniotomy upon catheter removal is possible. Secondary outcomes as time from induction till birth, vaginal deliveries and complications during or after birth for the mother or child will also become recorded.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Single Balloon Catheter
Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Foley Catheter
Foley Catheter 16-19 H
Double balloon catheter
Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Double Balloon Catheter
Double Balloon Catheter for 16-19H
Interventions
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Foley Catheter
Foley Catheter 16-19 H
Double Balloon Catheter
Double Balloon Catheter for 16-19H
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Indication to induce birth
* Unripe cervix
* Term date set by US before week 21
Exclusion Criteria
* Prematurity (\<37w)
* IUFD
* Letal malformations
* Low lying placenta
* Multiple pregnancies
* Breakage of amniotic fluid
* The woman does not understand norwegian
FEMALE
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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Womens hospital, Haukeland University Hospital
Locations
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Womens Hospital, Haukeland University Hospital
Bergen, , Norway
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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1728a (REK)
Identifier Type: -
Identifier Source: org_study_id
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