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

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:

1. 600 mcg of oral misoprostol in one dose, or

2. Standard surgical treatment (MVA)

In Moldova and Madagascar:

1. 600 mcg of oral misoprostol in one dose, or

2. 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2007

Intervention(s) in this Clinical Trial

• Drug: misoprostol
  • comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)
• Procedure: MVA
  • comparison of orally administered 600mcg of misoprostol to either sublingually administered 400mcg or Manual Vacuum Aspiration (MVA)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • treatment with 600mcg oral misoprostol
• Active Comparator: 2
  • treatment with 400mcg sublingual misoprostol
• Active Comparator: 3
  • treatment with Manual Vacuum Aspiration (MVA)

Primary Measures

• complete resolution of signs/symptoms of incomplete abortion without recourse to surgery at any point for any reason
  • Time Frame: one week after initial treatment with the option of an additional week
    Safety Issue?: Yes

Inclusion Criteria:

• If no ultrasound used:
• 1. Past or present history of vaginal bleeding during pregnancy; and 2. Open cervical os.
• If ultrasound used:
• 1. Past or present history of vaginal bleeding during pregnancy; and 2. 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

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:
• 1. foul smelling discharge, 2. fever > 39 degrees C , 3. pulse >110/min;

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

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  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670761

Study ID Number: 2.2.1

ClinicalTrials.gov Identifier: NCT00670761

Health Authority: United States: Institutional Review Board