Labour Induction With Misoprostol, Dinoprostone and Bard Catheter (LI)

January 15, 2008 updated by: Karolinska University Hospital

A Randomised Comparison Between Intravaginal Dinoprostone Intravaginal Misoprostol and Transcervical Balloon Catheter for Labour Induction

This is a randomised study aimed at comparing the currently most frequently used prostaglandin dinoprostone to two other methods, the cheaper and perhaps more effective prostaglandin misoprostol and a transcervical catheter. 592 women were recruited and randomised to one of the three methods. The main outcome measures were time to delivery, rate of instrumental deliveries and maternal neonatal outcome. Our hypothesis was that misoprostol would be superior to the other methods.

The main finding of our trial was that the catheter showed the shortest induction to delivery interval. There were no differences between the two other prostaglandins. No differences in maternal and neonatal outcome was found

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

592

Phase

  • Phase 3

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Full term singleton pregnancy with vertex presentation and with an indication for labour induction.
  • Absence of active labour
  • Bishop score ≤ 6.
  • Normal CTG registration

Exclusion Criteria:

  • Previous cesarean section
  • signs of infection
  • immediate need for delivery
  • any contraindication for vaginal delivery

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Labour induction with misoprostol
Drug: misoprostol
0.025mg tablet vaginally every 4 hour until progress
Other Names:
  • Cytotec, one quarter of a 0.100mg tablet
Active Comparator: 2
Labour induction with dinoprostone
Drug: dinoprostone
2mg vaginal gel every 6 hours until progress
Other Names:
  • Minprostin
Experimental: 3
Labour induction with bard
Device: Bard Catheter (balloon catheter)
Intracervical balloon catheter positioned above internal cervical os and filled with sterile water. Removed when cervix was dilated
Other Names:
  • Bard Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time from treatment start to delivery
Time Frame: At delivery
At delivery

Collaborators and Investigators

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

Sponsor

Karolinska University Hospital

Investigators

  • Principal Investigator: Lena Marions, MD PhD, Karolinska University Hospital Institute

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

December 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

January 2, 2008

First Submitted That Met QC Criteria

January 15, 2008

First Posted (Estimate)

January 28, 2008

Study Record Updates

Last Update Posted (Estimate)

January 28, 2008

Last Update Submitted That Met QC Criteria

January 15, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMS2007
  • KS2007

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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