Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia
This open-label study is being conducted to determine whether national expansion of a 400 mcg of sublingual misoprostol (i.e., under the tongue) taken 24 hours following administration of mifepristone 200 mg is effective and acceptable to new abortion providers in 14 regions.
The goal of this study is to provide answers to the following four questions:
- What is the effectiveness of this regimen of medical abortion with mifepristone followed by 400 mcg sublingual misoprostol up to 63 days since the last menstrual period (LMP)?
- Are the side effects with sublingual use tolerable for women?
- Is sublingual administration of misoprostol acceptable to women?
- Are women satisfied with counseling and services received in new centers offering medical abortion?
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||An Open Label Study of 400 mcg Sublingual Misoprostol Following Mifepristone 200 mg for Abortion up to 63 Days LMP|
- Need for surgical completion for incomplete abortions or ongoing viable pregnancies at follow up visit Study day 15. [ Time Frame: 2 weeks after mifepristone administration ] [ Designated as safety issue: No ]
- Side effects [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Acceptability for women [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01173003
|Centres (14) de Planification Familiale de L'ONFP|
|Tunis, Various, Tunisia|
|Study Chair:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|
|Study Director:||Rasha Dabash, MPH||Gynuity Health Projects|
|Principal Investigator:||Selma Hajri, MD||Reproductive Health Consultant|
|Principal Investigator:||Mongia Ben Attia, MD||Office Nationale de la Famille et de la Population|
|Study Chair:||N Gueddana, MD||ONFP|
|Principal Investigator:||Fatma Temimi, MD||ONFP|
|Principal Investigator:||E Hassairi||ONFP|