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

August 16, 2011 updated by: Haukeland University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • Womens Hospital, Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Cervical Ripening Balloon, Cook Medical

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervix dilatation >= 3cm
Time Frame: At cather removal
Cervix dilatation is assessed by vaginally examination at Catheter removal.
At cather removal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haukeland University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

March 20, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

August 17, 2011

Last Update Submitted That Met QC Criteria

August 16, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • 1728a (REK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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