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Patient Agreement Form and Medication Abortion Knowledge
Sponsor: University of California, San Francisco
Summary
This study evaluates whether exposure to the U.S. Food and Drug Administration (FDA)-required Patient Agreement Form (PAF) for mifepristone improves patient knowledge about medication abortion. Participants seeking medication abortion at clinical sites in the United States were randomized to complete a knowledge assessment either before or after reviewing and signing the PAF. The primary objective was to assess whether exposure to the PAF improves knowledge related to medication abortion, including medication use, effectiveness, risks, and when to seek medical care.
Official title: Effect of the Patient Agreement Form (PAF) for Mifepristone on Medication Abortion Knowledge: A Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
15 Years - Any
Study Type
INTERVENTIONAL
Enrollment
637
Start Date
2025-01-15
Completion Date
2025-10-17
Last Updated
2026-05-22
Healthy Volunteers
No
Interventions
Patient Agreement Form (PAF)
The Patient Agreement Form is a document required under the FDA Risk Evaluation and Mitigation Strategy (REMS) program for mifepristone. It includes information about medication abortion, including risks, side effects, and instructions for use, and must be reviewed and signed by patients prior to receiving the medication.
Locations (5)
Planned Parenthood Northern California
San Francisco, California, United States
Planned Parenthood Rocky Mountain
Denver, Colorado, United States
Choices
Carbondale, Illinois, United States
Aria Medical Center
Wichita, Kansas, United States
Planned Parenthood North Central States
Saint Paul, Minnesota, United States