Patient Agreement Form and Medication Abortion Knowledge

Conditions

• Health Knowledge Attitudes and Practice
• Medication Abortion
• Pregnant People

Eligibility Criteria

Sex

FEMALE

Age

15 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Patient Agreement Form (PAF) — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Jan 15, 2025

Status verified

May 2026

Primary completion

Oct 17, 2025

Completion

Oct 17, 2025

Study Design

Enrollment

637 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Arms

• Other: Arm 1: Control group (No PAF Exposure at Time of Assessment)
  Participants completed the knowledge survey before receiving and signing the Patient Agreement Form (PAF) and before receiving any PAF-related counseling. All participants were subsequently exposed to the intervention (PAF) as part of routine clinical care.
• Experimental: Arm 2: Exposed group (Exposed to PAF prior to assessment)
  Participants received and signed the Patient Agreement Form (PAF) and any site-standard PAF-related counseling prior to completing the knowledge survey.

Primary Outcome Measure

Medication abortion knowledge [ Time Frame: 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). ]

Locations (5)

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