Medication Abortion With Autonomous Self-Assessment Project (MA-ASAP)

Gynuity Health Projects

Status: Active, not recruiting

Conditions: Abortion Early

Treatments: Other: Screening for eligibility

Study type: Interventional

Funder types: Other

Identifiers

NCT05278780

1054

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Asynchronous screening

Experimental group

Description:

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.

Treatment:

Other: Screening for eligibility