Expansion Study of a Simplified Regimen of Medical Abortion Thru 63 Last Menstrual Period (LMP) in Tunisia
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|ClinicalTrials.gov Identifier: NCT01173003|
Recruitment Status : Completed
First Posted : July 30, 2010
Last Update Posted : February 19, 2014
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?
|Condition or disease||Intervention/treatment||Phase|
|Induced Abortion||Drug: Mifepristone, misoprostol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||688 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
- 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 ]
- Side effects [ Time Frame: 48 hours ]
- Acceptability for women [ Time Frame: 2 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|