Mail Order Mifepristone Study

Pregnancy Related Clinical Trial

Official title:

Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03913104
• Other study ID #: 18-26819
• Status: Completed
• Phase: Phase 4
• Start date: January 5, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Abortion Early
• Pregnancy Related

Intervention

Drug:
• Mifepristone
Patients will have Mifeprex? (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Grossman, MD

Country where clinical trial is conducted

United States, 

Outcome

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.