Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02219100|
Recruitment Status : Completed
First Posted : August 18, 2014
Last Update Posted : August 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Abortion, First Trimester||Drug: Home administration of 200 mg mifepristone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||613 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Acceptability and Feasibility of a Demedicalized Medical Abortion Regimen in the Caucasus|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Experimental: Home administration of mifepristone
This arm consisted of women who chose home administration of 200 mg mifepristone.
Drug: Home administration of 200 mg mifepristone
Home administration of 200 mg mifepristone
No Intervention: Clinic administration of mifepristone
This arm consisted of women who underwent clinic administration of 200 mg mifepristone.
- Proportion of abortions that are complete without surgical intervention (unit: percent). [ Time Frame: 15 days ]Percentage of women with complete abortion without the need of a surgical intervention.
- Proportion of women satisfied with procedure (unit: percent) and with side effects (unit: percent). [ Time Frame: 15 days ]Woman's satisfaction with her medical abortion procedure and side effects experienced.
- Proportion of Women Who Select Home-use of Mifepristone [ Time Frame: 1 week ]
- Proportion of Women Who Select Home-use of Misoprostol [ Time Frame: 1 week ]
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): NCT02219100
|Gyumri Maternity Hospital|
|Vanadzor Hospital #1|
|Family Planning Center|
|Gynecology Department of the Central Regional Hospital|
|Principal Investigator:||Beverly Winikoff, MD, MPH||Gynuity Health Projects|
|Principal Investigator:||Rena Bagirova, MD||Antenatal Clinic|
|Principal Investigator:||Mehriban Huseynova, MD||Gynecology Department of the Central Regional Hospital|
|Principal Investigator:||Aram Avalyan, MD||Vanadzor Hospital #1|
|Principal Investigator:||Alla Minasyan, MD||Gyumri Maternity Hospital|