JAMA internal medicine
October 19, 2026 · via Europe PMC
Mifepristone Patient Agreement Form and Medication Abortion Knowledge: A Randomized Clinical Trial.
Biggs MA, Ehrenreich K, Kaller S, Ralph L, Grossman D
AI summary — for doctors, generated from the abstract only
Reviewing and signing the mifepristone patient agreement form did not meaningfully increase medication abortion knowledge, which was already high after standard counselling.
What was studied
Randomized clinical trial at 5 US facilities (January to October 2025): 593 patients answered a 12-item knowledge survey either before (n = 301) or after (n = 292) receiving and signing the FDA-required form.
Key findings
- Adjusted mean knowledge was 10.37 of 12 items, with no group difference (adjusted difference 0.18; 95% CI -0.04 to 0.39).
- Nearly everyone knew to contact a provider for infection (99%) or heavy bleeding (96%).
- Least concordant items were how often treatment does not work (54%) and timing of misoprostol after mifepristone (77%).
Clinical relevance
Raises questions about whether the form requirement adds educational value, and highlights topics where counselling could be strengthened.
Who should care
Limitations
Knowledge was measured immediately, not behaviour or outcomes; participants were at five facilities and limited to English or Spanish proficiency. Policy conclusions go beyond what the trial measured.
The patient agreement form did not improve knowledge beyond standard counselling.
This is an AI-generated summary of the published abstract, not a clinical recommendation. It may not reflect the full text or subsequent updates — verify against the original source before acting on it.
Abstract
IMPORTANCE
While the US Food and Drug Administration requires medication abortion patients to review and sign a patient agreement form (PAF) under its Risk Evaluation and Mitigation Strategy program, there is limited research examining whether the PAF improves patient knowledge.
OBJECTIVE
To determine whether patients are more knowledgeable about medication abortion after reviewing and signing the PAF.
DESIGN, SETTING, AND PARTICIPANTS
People receiving mifepristone and misoprostol medications (15 years or older and proficient in English or Spanish) were recruited from 5 facilities in California, Colorado, Illinois, Kansas, and Minnesota (January to October 2025). After receiving standard clinic counseling and the mifepristone medication guide, patients were randomized into 2 study groups and then completed a survey either before (n = 301 control) or after (n = 292 exposed) receiving and signing the PAF. Data were analyzed December 2025 to August 2026.
INTERVENTION
The control group completed the survey before receiving the PAF and any PAF-related counseling. The exposed group received and signed the PAF and any PAF-related counseling and then completed a knowledge survey.
MAIN OUTCOMES AND MEASURES
Overall medication abortion knowledge (correct response to 12 items regarding when to seek medical care, effectiveness, administration, potential serious risks, and side effects) and responses to each individual knowledge item.
RESULTS
A total of 593 participants (mean [SD] age, 26.9 [5.8] years; 44 Asian/Pacific Islander [7%], 132 Black [22%], 181 Hispanic [31%], and 159 White [27%] individuals) completed knowledge items (301 control [51%]; 292 exposed [49%]). Across participant characteristics, study groups only differed significantly in reported abortion history. In adjusted analyses, participants answered a mean (95% CI) of 10.37 (10.26-10.48) of 12 knowledge items consistently with the PAF with no study group differences (control: difference, 10.26; exposed: difference, 10.44; adjusted difference, 0.18; 95% CI, -0.04 to 0.39). Nearly everyone knew to contact a "provider" if they "were to have an infection (590 [99%]) or heavy bleeding that soaked through 2 full-size sanitary pads per hour for 2 hours (566 [96%])." The items with answers that were least often concordant with the PAF included how often the treatment does not work (320 [54%]) and taking misoprostol 24 to 48 hours after mifepristone (458 [77%]).
CONCLUSIONS AND RELEVANCE
The randomized clinical trial found that patient knowledge about medication abortion following standard counseling was high. Exposure to the required PAF did not result in a clinically meaningful increase in medication abortion knowledge. The findings raise questions about the PAF requirement from the US Food and Drug Administration, as it does not appear to be useful.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT07604675.
DOI
10.1001/jamainternmed.2026.5197
PMID
42895726
Research metadata (titles, abstracts, authors, publication dates) is sourced from Europe PMC, which aggregates content from PubMed/MEDLINE, PubMed Central, and other providers under the U.S. National Library of Medicine (NLM/NCBI). NLM does not claim copyright on abstracts; the original journal publishers or authors may hold rights to the full articles. AI-generated summaries are derived only from the abstract, never the full text, and are always labeled as AI-generated.
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