Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term

December 9, 2013 updated by: Dr. debbie Robinson, University of Manitoba
The purpose of this study is to determine whether a titrated solution of oral Misoprostol is safe and effective at inducing labor at term, regardless of Bishop Score.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

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

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • St. Boniface General 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

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. term,
  2. singleton
  3. no contraindication to prostaglandins
  4. vertex
  5. no exposure to vaginal prostaglandins in the index pregnancy

Exclusion Criteria:

  1. parity > 3
  2. severe PIH: BP> 160/100, abnormal LFT's, proteinuria >1g/day
  3. previous uterine surgery
  4. regular uterine contractions
  5. maternal age > 45
  6. twins

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of vaginal delivery within 24 hours
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Uterine hyperstimulation rate
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

University of Manitoba

Investigators

  • Principal Investigator: debbie J Robinson, MD FRCSC, University of Manitoba

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)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 18, 2010

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2009:149

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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