Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: surgery standard surgical treatment (either dilation and curettage or manual vacuum aspiration) |
Procedure: surgery
standard surgical treatment (dilation and curettage or manual vacuum aspiration)
|
| Active Comparator: misoprostol 400 mcg misoprostol |
Drug: misoprostol
single dose of 400 mcg misoprostol administered sublingually
|
Outcome Measures
Primary Outcome Measures
- Complete abortion without recourse to surgical intervention. [follow up visit 7 days after initial treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Uterine size no larger than 12 weeks LMP at time of presentation for care.
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Past or present history of vaginal bleeding during pregnancy.
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Open cervical os.
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If ultrasound used evidence of incomplete abortion with substantial debris in the uterus.
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All women would have been advised to have surgical evacuation of the uterus if misoprostol was not available.
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General good health.
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Willing to provide contact information for purposes of follow-up.
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Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger, Mauritania and Senegal).
Exclusion Criteria:
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Contraindications to study drug
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Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
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Hemodynamic disturbances (pulse >110/min and systolic bp <100)
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Have an IUD in place; (the IUD may be removed making the woman eligible)
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Suspected ectopic pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dandé District Hospital/Ziniaré District Hospital | Dande/Ziniare | Burkina Faso | ||
| 2 | El-Galaa Teaching Hospital | Cairo | Egypt | ||
| 3 | Shatby Maternity Hospital/Alexandria University | Shatby, Alexandria | Egypt | ||
| 4 | Cheikh Zayed Hospital | Nouakchott | Mauritania | ||
| 5 | Maternite Issaka Gazobi | Niamey | Niger | ||
| 6 | Centre de Sante Le Roi Baudouin | Guediawaye | Senegal |
Sponsors and Collaborators
- Gynuity Health Projects
Investigators
- Principal Investigator: Beverly Winikoff, MD, MPH, Gynuity Health Projects
- Study Director: Rasha Dabash, MPH, Gynuity Health Projects
- Study Director: Ayisha Diop, MPH, Gynuity Health Projects
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2.2.2