Misoprostol for the Treatment of Incomplete Abortion

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.

Conditions

• Abortion, Incomplete

Interventions

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)

Sponsors & Collaborators

• Befelatanana Maternity Centre

  collaborator UNKNOWN

• Municipal Clinical Hospital No. 1

  collaborator UNKNOWN

• Kagera Regional Hospital

  collaborator OTHER

• Jose Macamo Hospital

  collaborator UNKNOWN

• Tudu hospital

  collaborator UNKNOWN

• National OBGYN hospital

  collaborator UNKNOWN

• Cuchi General District hospital

  collaborator UNKNOWN

• Hôpital de District Sanitaire Dandé

  collaborator UNKNOWN

• Hôpital de District Sanitaire de Ziniaré

  collaborator UNKNOWN

• Gynuity Health Projects

  lead OTHER

Principal Investigators

• Beverly Winikoff, MD, MPH · Gynuity Health Projects

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-07-31

Primary Completion

2010-04-30

Completion

2010-12-31

Countries

• Burkina Faso
• Madagascar
• Moldova
• Mozambique
• Tanzania

Study Locations