Clinical Trial: Misoprostol for the Treatment of Incomplete Abortion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.


Detailed Summary: Not available
Sponsor: Gynuity Health Projects

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Gynuity Health Projects

Dates:
Date Received: April 29, 2008
Date Started: July 2004
Date Completion:
Last Updated: July 26, 2016
Last Verified: July 2016