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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. debbie Robinson, University of Manitoba
ClinicalTrials.gov Identifier:
NCT01070472
First received: February 16, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Labor Induction at Term
Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Rate of vaginal delivery within 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Uterine hyperstimulation rate [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Misoprostol
    titrated oral misoprostol solution
  Eligibility

Ages Eligible for Study:   18 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070472

Locations
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: debbie J Robinson, MD FRCSC University of Manitoba
  More Information

No publications provided

Responsible Party: Dr. debbie Robinson, Dr, University of Manitoba
ClinicalTrials.gov Identifier: NCT01070472     History of Changes
Other Study ID Numbers: B2009:149
Study First Received: February 16, 2010
Last Updated: December 9, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Manitoba:
labor induction at term using a titrated oral misoprostol solution

Additional relevant MeSH terms:
Misoprostol
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on April 17, 2014