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

NCT00466999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2012-03-30

No results posted yet for this study

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

DRUG

misoprostol

single dose of 400 mcg misoprostol administered sublingually

PROCEDURE

surgery

standard surgical treatment (dilation and curettage or manual vacuum aspiration)

Sponsors & Collaborators

  • Gynuity Health Projects

    lead OTHER

Principal Investigators

  • Beverly Winikoff, MD, MPH · Gynuity Health Projects

  • Rasha Dabash, MPH · Gynuity Health Projects

  • Ayisha Diop, MPH · Gynuity Health Projects

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • Burkina Faso
  • Egypt
  • Mauritania
  • Niger
  • Senegal

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00466999 on ClinicalTrials.gov