Patient Agreement Form and Medication Abortion Knowledge (NCT07604675) | Clinical Trial Compass
CompletedNot Applicable
Patient Agreement Form and Medication Abortion Knowledge
United States637 participantsStarted 2025-01-15
Plain-language 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.
Who can participate
Age range
15 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 15 years or older
* Able to read and speak English or Spanish
* Seeking medication abortion or receiving mifepristone for miscarriage management
Exclusion Criteria:
* Does not meet inclusion criteria
* Unable or unwilling to provide informed consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Medication abortion knowledge
Timeframe: Knowledge will be assessed only once, during the same clinicial visit on the day of recruitment (Day 1), following standard counseling (before or after exposure to the PAF depending on assigned study group).