Medication Abortion With Autonomous Self-Assessment Project

Study Overview
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Brief Summary
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In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service.

Detailed Description
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In this study, the investigators propose to create and pilot-test an asynchronous medication abortion (MA) provision service. The foundation of this service will be a website that provides information combined with a linked screening questionnaire. The questionnaire will be designed to collect the information recommended by current MA guidelines for history-based MA eligibility assessment. If the patient's responses meet specified criteria, the questionnaire will be sent to a study clinician, who will then determine whether a real-time clinical consultation or facility-based tests are needed. If the clinician decides that they are not, treatment will be provided accordingly. The primary goal of the study is to collect preliminary data on feasibility of the approach, abortion outcomes, and participant satisfaction. The investigators will use these data to determine whether to proceed with further development of asynchronous MA provision.

Official Title
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Medication Abortion With Autonomous Self-Assessment Project: Pilot Study

Conditions
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Abortion Early

Intervention / Treatment
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* Other: Screening for eligibility


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Has reviewed the study website Can speak and read English Has an address in a state where the study clinicians are licensed to practice medicine and where the service is legal Is at least 18 years old Is pregnant with a gestational age of ≤54 days from last menstrual period Desires MA Has not had an ultrasound in the current pregnancy (see below) Has no symptoms of or risk factors for ectopic pregnancy Has no medical contraindications to MA, specifically: Hemorrhagic disorder or concurrent anticoagulant therapy Chronic adrenal failure Concurrent long-term systemic corticosteroid therapy Inherited porphyria Allergy to mifepristone or misoprostol, or other prostaglandin Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: Case series study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Asynchronous screening<br>Participants will be screened for medication abortion eligibility using written or online materials and questionnaires, without a synchronous conversation between the prescribing clinician and the patient. | Other: Screening for eligibility<br>* Asynchronous screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events | Proportion of treated participants with SAE (serious adverse effects) related to the study | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of participant questions | The proportion of participants who have questions after completing the questionnaire | 12 months |