Mail Order Mifepristone Study
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|ClinicalTrials.gov Identifier: NCT03913104|
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Abortion Early Pregnancy Related||Drug: Mifepristone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||425 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective Cohort|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||January 2023|
Experimental: Medication Abortion Patients
Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone) or vaginally (as soon as 6 hours following mifepristone)
Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
- Proportion of patients who report positive experience. [ Time Frame: Day 14 following initial medication abortion visit ]Proportion of patients reporting whether they would use the mail order service again if they needed another abortion.
- Proportion of patients who report timely delivery of medication. [ Time Frame: Day 3 following initial medication abortion visit ]Proportion of patients who receive medications by Day 2 and Day 3 and proportion of patients who indicate their confidentiality was maintained when receiving medications by mail. The investigators will also estimate the proportion of patients who report that medications were lost, stolen or damaged.
- Proportion of patients who have a complete abortion [ Time Frame: Up to 6 weeks after initial medication abortion visit. ]Using electronic health record data related to abortion, the investigators will estimate the proportion of patients who experience a complete abortion and the proportion of patients who experience complications, including adverse or severe adverse events.
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): NCT03913104
|Contact: Rana Barar, MPHfirstname.lastname@example.org|
|Contact: Sarah Raifman, MScemail@example.com|
|United States, New York|
|Albert Einstein College of Medicine||Not yet recruiting|
|New York, New York, United States, 10461|
|Contact: Marji Gold, MD|
|Principal Investigator: Marji Gold, MD|
|Principal Investigator:||Daniel Grossman, MD||University of California, San Francisco|