Medication Abortion With Autonomous Self-Assessment Project

NCT ID: NCT05278780

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-04-15

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.

Conditions

Abortion Early

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Asynchronous screening

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.

Group Type: EXPERIMENTAL

Screening for eligibility

Intervention Type: OTHER

Asynchronous screening

Interventions

Screening for eligibility

Asynchronous screening

Intervention Type: OTHER

Eligibility Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

Planned Parenthood of the Rocky Mountains

UNKNOWN

Sponsor Role: collaborator

Planned Parenthood North Central States

UNKNOWN

Sponsor Role: collaborator

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Planned Parenthood of the Rocky Mountains

Boulder, Colorado, United States

Planned Parenthood North Central States

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

1054

Identifier Type: -

Identifier Source: org_study_id