Labour Induction With Misoprostol, Dinoprostone and Bard Catheter - Tabular View

Tracking Information

First Received Date ^ICMJE

January 2, 2008

Last Updated Date

January 15, 2008

Start Date ^ICMJE

December 2004

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time from treatment start to delivery [ Time Frame: At delivery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00602095 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Labour Induction With Misoprostol, Dinoprostone and Bard Catheter

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pregnancy

Intervention ^ICMJE

Drug: misoprostol
Drug: dinoprostone
Device: Bard Catheter (balloon catheter)

Study Arms / Comparison Groups

Experimental: Labour induction with misoprostol
Active Comparator: Labour induction with dinoprostone
Experimental: Labour induction with bard

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

592

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00602095

Responsible Party

Lena Marions MD PhD, Karolinska University Hospital

Study ID Numbers ^ICMJE

LMS2007, KS2007

Study Sponsor ^ICMJE

Karolinska University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lena Marions, MD PhD

Karolinska University Hospital Institute

Information Provided By

Karolinska University Hospital

Verification Date

January 2008

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