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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: November 2008

Intervention(s) in this Clinical Trial

• Drug: misoprostol
  • single dose of 400 mcg misoprostol administered sublingually
• Procedure: surgery
  • standard surgical treatment (dilation and curettage or manual vacuum aspiration)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: surgery
  • standard surgical treatment (either dilation and curettage or manual vacuum aspiration)
• Active Comparator: misoprostol
  • 400 mcg misoprostol

Primary Measures

• Complete abortion without recourse to surgical intervention.
  • Time Frame: follow up visit 7 days after initial treatment
    Safety Issue?: No

Inclusion Criteria:

• Uterine size no larger than 12 weeks LMP at time of presentation for care.
• Past or present history of vaginal bleeding during pregnancy.
• Open cervical os.
• If ultrasound used 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.
• General good health.
• Willing to provide contact information for purposes of follow-up.
• Also in Egypt: 21 years of age or over or parental permission (there is no minimum age requirement in Niger and Mauritania).

Exclusion Criteria:

• Contraindications to study drug
• Signs of severe infection, defined as at least one of the following: 1) foul smelling discharge, 2) fever > 38 degrees C , 3) uterine tenderness
• Hemodynamic disturbances (pulse >110/min and systolic bp <100)
• Have an IUD in place; (the IUD may be removed making the woman eligible)
• Suspected ectopic pregnancy

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Gynuity Health Projects

Overall Clinical Trial Officials and Contacts

Beverly Winikoff, MD, MPH Principal Investigator Gynuity Health Projects  

Overall Contact: Beverly Winikoff, MD, MPH 1-212-448-1230 bwinikoff@gynuity.org

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00466999

Study ID Number: 2.2.2

ClinicalTrials.gov Identifier: NCT00466999

Health Authority: Egypt: Local Ethical Committee