Medication Abortion With Autonomous Self-Assessment Project

Not Applicable

Completed

• Conditions: Abortion Early
• Interventions: Other: Screening for eligibility

• Registration Number: NCT05278780
• Lead Sponsor: Gynuity Health Projects

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-03
• Study First Posted: 2022-03-14
• Study Start: 2022-06-01
• Status Verified: 2023-03
• Primary Completion: 2023-03-01
• Study Completion: 2023-04-15
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Asynchronous screening	Screening for eligibility	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	12 months	Proportion of treated participants with SAE (serious adverse effects) related to the study

Secondary Outcome Measures

Name	Time	Method
Incidence of participant questions	12 months	The proportion of participants who have questions after completing the questionnaire

Trial Locations

Locations (2)

Planned Parenthood of the Rocky Mountains; 🇺🇸 Boulder, Colorado, United States

Planned Parenthood North Central States; 🇺🇸 Saint Paul, Minnesota, United States