NCT00466999

Sublingual Misoprostol Versus Standard Surgical Care for the Treatment of Incomplete Abortion

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (actual)
• Sponsor: Gynuity Health Projects · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Incomplete Abortion

Interventions

Type	Name	Description
DRUG	misoprostol	single dose of 400 mcg misoprostol administered sublingually
PROCEDURE	surgery	standard surgical treatment (dilation and curettage or manual vacuum aspiration)

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-04-27
• Last updated: 2012-03-30

Locations

6 sites across 5 countries: Burkina Faso, Egypt, Mauritania, Niger, Senegal