Misoprostol for the Treatment of Incomplete Abortion

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

In Burkina Faso and Vietnam:

1. 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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gynuity Health Projects
• Collaborators: Befelatanana Maternity Centre; Cuchi General District hospital; Hôpital de District Sanitaire Dandé; Hôpital de District Sanitaire de Ziniaré; Jose Macamo Hospital; Kagera Regional Hospital; Municipal Clinical Hospital No. 1; National OBGYN hospital; Tudu hospital
• Treatments: Misoprostol

Criteria

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

• In Vietnam: reproductive age

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;