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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Pharmaceutical Solutions
Misoprostol
Therapeutic Uses
Pharmacologic Actions
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on September 30, 2014