Misoprostol for the Treatment of Incomplete Abortion

Study Overview
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Brief Summary
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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: 600 mcg of oral misoprostol in one dose, or Standard surgical treatment (MVA) In Moldova and Madagascar: 600 mcg of oral misoprostol in one dose, or 400 mcg of sublingual misoprostol in one dose. In Burkina Faso and Vietnam: 1. 400 mcg of sublingual misoprostol in one dose. 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.

Official Title
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Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options

Conditions
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Abortion, Incomplete

Intervention / Treatment
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* Drug: misoprostol
* Procedure: MVA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: If no ultrasound used: Past or present history of vaginal bleeding during pregnancy; and Open cervical os. If ultrasound used: Past or present history of vaginal bleeding during pregnancy; and Evidence of incomplete abortion with substantial debris in the uterus. 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. In Tanzania: 18 years of age or over or parental permission In Mozambique: 21 years of age or over or parental permission In Moldova: 18 years of age or over In Madagascar: 18 years of age or parental permission In Vietnam: reproductive age Exclusion Criteria: Contraindications to the study drug; Uterine size larger than 12 weeks L.M.P. at time of presentation for care. Signs of severe infection, defined as at least one of the following of: foul smelling discharge, fever > 39 degrees C , pulse >110/min;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>treatment with 600mcg oral misoprostol | Drug: misoprostol<br>* comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)<br>* Other names: Cytotec;|
| Active Comparator: 2<br>treatment with 400mcg sublingual misoprostol | Drug: misoprostol<br>* comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)<br>* Other names: Cytotec;|
| Active Comparator: 3<br>treatment with Manual Vacuum Aspiration (MVA) | Procedure: MVA<br>* comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason |  | one week after initial treatment with the option of an additional week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postabortion care, misoprostol, incomplete abortion, sublingual, MVA