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| Sponsors and Collaborators: |
Gynuity Health Projects Befelatanana Maternity Centre Antananarivo, Madagascar Municipal Clinical Hospital No. 1, Chisinau, Republic of Moldova Kagera Regional Hospital, Bukoba, Tanzania Jose Macamo Hospital, Maputo Mozambique |
| Information provided by: | Gynuity Health Projects |
| ClinicalTrials.gov Identifier: | NCT00670761 |
Purpose
This randomized study will examine the efficacy, safety and acceptability of misoprostol for treatment of incomplete abortion.
Women diagnosed with incomplete abortion will be randomized to receive one of the following regimens:
In Tanzania and Mozambique:
In Moldova and Madagascar:
We hypothesize that treatment of incomplete abortion with either 400 mcg sublingual misoprostol, 600 mcg oral misoprostol or MVA are equally effective in evacuating the uterus.
| Condition | Intervention |
|
Abortion, Incomplete |
Drug: misoprostol Procedure: MVA |
| MedlinePlus related topics: | Abortion Pregnancy Loss |
| ChemIDplus related topics: | Misoprostol |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options |
| Enrollment: | 720 |
| Study Start Date: | July 2004 |
| Study Completion Date: | April 2007 |
| Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
1: Active Comparator
treatment with 600mcg oral misoprostol
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Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
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2: Active Comparator
treatment with 400mcg sublingual misoprostol
|
Drug: misoprostol
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
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3: Active Comparator
treatment with Manual Vacuum Aspiration (MVA)
|
Procedure: MVA
comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
|
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
If no ultrasound used:
If ultrasound used:
All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
Willing to provide contact information for purposes of follow-up.
Exclusion Criteria:
Signs of severe infection, defined as at least one of the following of:
Contacts and Locations| Madagascar | |||||
| Befelatanana Maternity Centre | |||||
| Antananarivo, Madagascar | |||||
| Moldova, Republic of | |||||
| Municipal Clinical Hospital | |||||
| Chishinau, Moldova, Republic of | |||||
| Mozambique | |||||
| Jose Macamo Hospital | |||||
| Maputo, Mozambique | |||||
| Tanzania | |||||
| Kagera Regional Hospital | |||||
| Bukoba, Tanzania | |||||
| Gynuity Health Projects |
| Befelatanana Maternity Centre Antananarivo, Madagascar |
| Municipal Clinical Hospital No. 1, Chisinau, Republic of Moldova |
| Kagera Regional Hospital, Bukoba, Tanzania |
| Jose Macamo Hospital, Maputo Mozambique |
| Principal Investigator: | Beverly Winikoff, MD, MPH | Gynuity Health Projects |
More Information
| Responsible Party: | Gynuity Health Projects ( Beverly Winikoff, MD, MPH ) |
| Study ID Numbers: | 2.2.1 |
| First Received: | April 29, 2008 |
| Last Updated: | May 1, 2008 |
| ClinicalTrials.gov Identifier: | NCT00670761 |
| Health Authority: | United States: Institutional Review Board; Mozambique: Maputo Health Directorate, Maputo, Mozambique; Madagascar: Comité d'Ethique du Ministère de la Santé, Madagascar; Moldova: Municipal Clinical Hospital No. 1 Ethics Comittee, Moldova, Republic of; Tanzania: Western Institutional Review Board |
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