Medication Abortion With Autonomous Self-Assessment Project (MA-ASAP)

Medication Abortion With Autonomous Self-Assessment Project: Pilot Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Abortion Early
• Intervention / Treatment: Other: Screening for eligibility

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80207
      • Planned Parenthood of the Rocky Mountains
  • Minnesota
    • Saint Paul, Minnesota, United States, 55114
      • Planned Parenthood North Central States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Screening for eligibility; Asynchronous screening

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of participant questions	The proportion of participants who have questions after completing the questionnaire	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants who liked the service	Participant satisfaction upon exiting study evaluated using a participant satisfaction survey questionnaire	12 months

Collaborators and Investigators

• Sponsor: Gynuity Health Projects
• Collaborators: Stanford University; Planned Parenthood of the Rocky Mountains; Planned Parenthood North Central States

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Anticipated): April 15, 2023

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: March 3, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No