Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-27 @ 10:14 PM
Study NCT ID:
NCT00670761
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2008-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol for the Treatment of Incomplete Abortion
Sponsor:
Gynuity Health Projects
Organization:
Study Overview
Official Title:
Misoprostol for the Treatment of Incomplete Abortion: Comparison of Treatment Options
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: