Medication Abortion With Autonomous Self-Assessment Project

NCT05278780 | Completed

• 1 other identifier: 1054
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Abortion Early

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

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

  12 months

Secondary Outcomes (1)

• Incidence of participant questions

  12 months

Other Outcomes (1)

• Proportion of participants who liked the service

  12 months

Study Arms (1)

Asynchronous screening

EXPERIMENTAL

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

Interventions

Screening for eligibility OTHER

Asynchronous screening

Asynchronous screening

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Gynuity Health Projects: lead
• Stanford University: collaborator
• Planned Parenthood of the Rocky Mountains: collaborator
• Planned Parenthood North Central States: collaborator

Study Sites (2)

Planned Parenthood of the Rocky Mountains

Boulder, Colorado, 80207, United States

Location

Planned Parenthood North Central States

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

Mass Screening; Eligibility Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case series study

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 14, 2022
• Study Start: June 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 15, 2023
• Last Updated: January 27, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)