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
  Purpose

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 Intervention Phase
Induction of Birth
Device: Foley Catheter
Device: Double Balloon Catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Induction of Labor With Single and Double Balloon Catheters, a Randomized Controlled Study

Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Cervix dilatation >= 3cm [ Time Frame: At cather removal ] [ Designated as safety issue: No ]
    Cervix dilatation is assessed by vaginally examination at Catheter removal.


Enrollment: 180
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091285

Locations
Norway
Womens Hospital, Haukeland University Hospital
Bergen, Norway
Sponsors and Collaborators
Haukeland University Hospital
  More Information

No publications provided

Responsible Party: Birte Haugland, Dr, Womens hospital, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT01091285     History of Changes
Other Study ID Numbers: 1728a (REK)
Study First Received: March 20, 2010
Last Updated: August 16, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

ClinicalTrials.gov processed this record on July 22, 2014