Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
|ClinicalTrials.gov Identifier: NCT01091285|
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : August 17, 2011
A randomized controlled double blinded study to investigate whether a specially designed double balloon catheter is more efficient than a foley catheter for cervical ripening and induction of birth.
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.
|Condition or disease||Intervention/treatment||Phase|
|Induction of Birth||Device: Foley Catheter Device: Double Balloon Catheter||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
Active Comparator: Single Balloon Catheter
Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Device: Foley Catheter
Foley Catheter 16-19 H
Active Comparator: Double balloon catheter
Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin
Device: Double Balloon Catheter
Double Balloon Catheter for 16-19H
Other Name: Cervical Ripening Balloon, Cook Medical
- Cervix dilatation >= 3cm [ Time Frame: At cather removal ]Cervix dilatation is assessed by vaginally examination at Catheter removal.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091285
|Womens Hospital, Haukeland University Hospital|