Medication Abortion With Autonomous Self-Assessment Project

Gynuity Health Projects200 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

200

Conditions

Abortion Early

Interventions

Screening for eligibilityOTHER

Asynchronous screening

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: \-

Locations (2)

Planned Parenthood of the Rocky Mountains

Boulder, Colorado, United States

Planned Parenthood North Central States

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Proportion of treated participants with SAE (serious adverse effects) related to the study

Time frame: 12 months

Secondary Outcomes

Incidence of participant questions

The proportion of participants who have questions after completing the questionnaire

Time frame: 12 months

Data from ClinicalTrials.gov

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