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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01070472
Recruitment Status : Completed
First Posted : February 18, 2010
Last Update Posted : December 10, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. debbie Robinson, University of Manitoba

Brief Summary:
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 or disease Intervention/treatment Phase
Labor Induction at Term Drug: Misoprostol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol


Intervention Details:
  • Drug: Misoprostol
    titrated oral misoprostol solution


Primary Outcome Measures :
  1. Rate of vaginal delivery within 24 hours [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Uterine hyperstimulation rate [ Time Frame: 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01070472


Locations
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Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: debbie J Robinson, MD FRCSC University of Manitoba
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Responsible Party: Dr. debbie Robinson, Dr, University of Manitoba
ClinicalTrials.gov Identifier: NCT01070472    
Other Study ID Numbers: B2009:149
First Posted: February 18, 2010    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013
Keywords provided by Dr. debbie Robinson, University of Manitoba:
labor induction at term using a titrated oral misoprostol solution
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics