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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

March 20, 2010
August 16, 2011
March 2010
January 2011   (final data collection date for primary outcome measure)
Cervix dilatation >= 3cm [ Time Frame: At cather removal ] [ Designated as safety issue: No ]
Cervix dilatation is assessed by vaginally examination at Catheter removal.
Same as current
Complete list of historical versions of study NCT01091285 on ClinicalTrials.gov Archive Site
Not Provided
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Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study
Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Induction of Birth
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01091285
1728a (REK)
Not Provided
Birte Haugland, Dr, Womens hospital, Haukeland University Hospital
Haukeland University Hospital
Not Provided
Not Provided
Haukeland University Hospital
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP