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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | April 25, 2007 | ||||||||||||
| Last Updated Date | October 1, 2009 | ||||||||||||
| Start Date ICMJE | May 2007 | ||||||||||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Complete abortion without recourse to surgical intervention. [ Time Frame: follow up visit 7 days after initial treatment ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Complete abortion without recourse to surgical intervention. | ||||||||||||
| Change History | Complete list of historical versions of study NCT00466999 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion | ||||||||||||
| Official Title ICMJE | |||||||||||||
| Brief Summary | In this study, we will compare the safety and efficacy of 400 mcg sublingually administered misoprostol alone to standard surgical care for the treatment of incomplete abortion. This study will provide important data on the role of misoprostol in health services offering an array of treatments for incomplete abortion. Women could significantly benefit from a non-invasive treatment option for incomplete abortion. While safe surgical services are becoming more widespread, there is still a serious risk of complications from these procedures. Especially in developing countries, infection, hemorrhage and uterine damage are still too common. Medical treatment of incomplete abortion using misoprostol would be a tremendous step to reducing morbidity and mortality due to abortion complications. |
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| Detailed Description | |||||||||||||
| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||||||||||
| Condition ICMJE | Incomplete Abortion | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||||||
| Completion Date | |||||||||||||
| Estimated Primary Completion Date | May 2010 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||
| Ages | |||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Egypt, Mauritania, Niger | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00466999 | ||||||||||||
| Responsible Party | Dr. Beverly Winikoff, Gynuity Health Projects | ||||||||||||
| Study ID Numbers ICMJE | 2.2.2 | ||||||||||||
| Study Sponsor ICMJE | Gynuity Health Projects | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Gynuity Health Projects | ||||||||||||
| Verification Date | October 2009 | ||||||||||||
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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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