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
Recruitment status was Recruiting
Sponsor:
University of Manitoba
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT01070472
First received: February 16, 2010
Last updated: March 16, 2011
Last verified: March 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 16, 2010 | ||||||||
| Last Updated Date | March 16, 2011 | ||||||||
| Start Date ICMJE | March 2010 | ||||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Rate of vaginal delivery within 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01070472 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Uterine hyperstimulation rate [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term | ||||||||
| Official Title ICMJE | Efficacy and Safety of Titrated Oral Misoprostol Solution for Labor Induction at Term | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Labor Induction at Term | ||||||||
| Intervention ICMJE | Drug: Misoprostol
titrated oral misoprostol solution |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 250 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | November 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 44 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01070472 | ||||||||
| Other Study ID Numbers ICMJE | B2009:149 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Dr. debbie Robinson, University of Manitoba | ||||||||
| Study Sponsor ICMJE | University of Manitoba | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Manitoba | ||||||||
| Verification Date | March 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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