MA-ASAP at Independent Abortion Clinics: A Demonstration Project

NCT ID: NCT05781061

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-16
• Study Completion Date: 2023-06-15

Brief Summary

In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic.

Detailed Description

In this study, the investigators propose to conduct a parallel study to the MA-ASAP pilot study (ClinicalTrials.gov Identifier: NCT05278780) at one or more independent abortion clinics. This new study will be similar in structure to pilot study, except that all completed screening questionnaires will be sent to the study site rather than only those deemed eligible according a computer algorithm. The investigators expect that this change will better serve the needs of both clinics and patients, and it will also allow us to assess whether the algorithm is overly restrictive, i.e., whether it is excluding patients who are in fact eligible for MA. The primary goal of the study is to collect data on feasibility of the approach and safety. Secondarily, the investigators aim to assess the ability of a defined set of responses to the screening questionnaire to predict the clinician's decision about whether a clinical consultation is needed.

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 for MA Eligibility

Interventions

Screening for Eligibility

Asynchronous Screening for MA Eligibility

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 old enough to consent to abortion and study participation without parental consent in the study state
• Has reviewed the study website
• Has had a positive pregnancy test
• Has signed the study informed consent form (ICF), which will be included within the questionnaire
• Is pregnant with a gestational age of ≤77 days from last menstrual period
• Desires MA
• 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 not asked by the site to have a synchronous consultation with clinician OR facility-based tests such as ultrasound, laboratory tests, examination, etc.
• Is comfortable obtaining the abortion pills without a pre-treatment ultrasound and without speaking by phone or video with the abortion provider.

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

Sponsors

All Families Healthcare

UNKNOWN

Sponsor Role: collaborator

Gynuity Health Projects

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

All Families Healthcare

Whitefish, Montana, United States

Countries

United States

Other Identifiers

1059

Identifier Type: -

Identifier Source: org_study_id