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MA-ASAP: Medication Abortion With Autonomous Self-Assessment Project

Sponsor
Gynuity Health Projects (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05278780
Collaborator
Stanford University (Other), Planned Parenthood of the Rocky Mountains (Other), Planned Parenthood North Central States (Other)
200
Enrollment
1
Arm
33.6
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Screening for eligibility
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Case series studyCase series study
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Medication Abortion With Autonomous Self-Assessment Project: Pilot Study
Anticipated Study Start Date :
Mar 15, 2022
Anticipated Primary Completion Date :
Jan 1, 2025
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Safety [2 years]

    Adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT05278780
Other Study ID Numbers:
  • 1054
First Posted:
Mar 14, 2022
Last Update Posted:
Mar 14, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of Mar 14, 2022