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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Manitoba.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01070472
First received: February 16, 2010
Last updated: March 16, 2011
Last verified: March 2011
History of Changes
  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:

Drug Information available for: Misoprostol
U.S. FDA Resources

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
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2010 (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

Contacts
Contact: debbie J Robinson, MD FRCSC 204 237 4634 drdrobinson@mts.net
Contact: Michael Helewa, MD FRCSC 204 237 2549 mhelewa@sbgh.mb.ca

Locations
Canada, Manitoba
St. Boniface General Hospital Recruiting
Winnipeg, Manitoba, Canada
Contact: debbie j Robinson, FRCSC     931-3270     drdrobinson@mts.net    
Principal Investigator: debbie J Robinson, MD FRCSC            
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, University of Manitoba
ClinicalTrials.gov Identifier: NCT01070472     History of Changes
Other Study ID Numbers: B2009:149
Study First Received: February 16, 2010
Last Updated: March 16, 2011
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 May 23, 2013