Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study

This study has been completed.

Sponsor:

Information provided by:

Haukeland University Hospital

ClinicalTrials.gov Identifier:

NCT01091285

First received: March 20, 2010

Last updated: August 16, 2011

Last verified: April 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	March 20, 2010
Last Updated Date	August 16, 2011
Start Date ^ICMJE	March 2010
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 22, 2010)	Cervix dilatation >= 3cm [ Time Frame: At cather removal ] [ Designated as safety issue: No ] Cervix dilatation is assessed by vaginally examination at Catheter removal.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01091285 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
Official Title ^ICMJE	Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Induction of Birth
Intervention ^ICMJE	Device: Foley Catheter Foley Catheter 16-19 H Device: Double Balloon Catheter Double Balloon Catheter for 16-19H Other Name: Cervical Ripening Balloon, Cook Medical
Study Arm (s)	Active Comparator: Single Balloon Catheter Cervix Ripening is achieved by a single balloon catheter. Further induction by cytotec or/amniotomy and pitocin Intervention: Device: Foley Catheter Active Comparator: Double balloon catheter Cervix Ripening is achieved by a double balloon catheter. Further induction by cytotec or/amniotomy and pitocin Intervention: Device: Double Balloon Catheter
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	180
Completion Date	January 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Singleton pregnancy above week 37 Indication to induce birth Unripe cervix Term date set by US before week 21 Exclusion Criteria: Ripe cervix Prematurity (<37w) IUFD Letal malformations Low lying placenta Multiple pregnancies Breakage of amniotic fluid The woman does not understand norwegian
Gender	Female
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01091285
Other Study ID Numbers ^ICMJE	1728a (REK)
Has Data Monitoring Committee	Not Provided
Responsible Party	Birte Haugland, Dr, Womens hospital, Haukeland University Hospital
Study Sponsor ^ICMJE	Haukeland University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Haukeland University Hospital
Verification Date	April 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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