Pregnancy Related Clinical Trial
Official title:
Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy
Verified date | March 2024 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.
Status | Completed |
Enrollment | 538 |
Est. completion date | December 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years and older |
Eligibility | Inclusion Criteria: - Women seeking medication abortion through 63 days gestation - Eligible for Mifeprex? at a study site - English or Spanish speaking - Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit Exclusion Criteria: - Not pregnant - Not seeking medication abortion - under the age of 15 - Over 63 days gestation - Contraindicated for medication abortion |
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Comprehensive Wellness Clinic | Atlanta | Georgia |
United States | Delaware County Women's Center | Chester | Pennsylvania |
United States | Planned Parenthood Rocky Mountains | Denver | Colorado |
United States | Albert Einstein College of Medicine | New York | New York |
United States | Children's Hospital Oakland | Oakland | California |
United States | Highland Hospital | Oakland | California |
United States | Brown Family Medicine | Pawtucket | Rhode Island |
United States | Allegheny Reproductive Health Center | Pittsburgh | Pennsylvania |
United States | Lifespan | Providence | Rhode Island |
United States | Southern Tier Women's Health Services | Vestal | New York |
United States | Christiana Care Health System | Wilmington | Delaware |
Lead Sponsor | Collaborator |
---|---|
Daniel Grossman, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who report positive experience. | Proportion of patients reporting whether they would use the mail order service again if they needed another abortion. | Day 14 following initial medication abortion visit | |
Secondary | Proportion of patients who report timely delivery of medication. | 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. | Day 3 following initial medication abortion visit | |
Secondary | Proportion of patients who have a complete abortion | 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. | Up to 6 weeks after initial medication abortion visit. |
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