Clinical trial NCT05278780: Medication Abortion With Autonomous Self-Assessment Project
Official title: Medication Abortion With Autonomous Self-Assessment Project: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion Early
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: Stanford University
name: Planned Parenthood of the Rocky Mountains
name: Planned Parenthood North Central States
First posted: 2022-03-14
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series study
Primary purpose: SCREENING

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.

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:

-

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Incidence of participant questions
timeFrame: 12 months
Other outcomes:
measure: Proportion of participants who liked the service
timeFrame: 12 months
Locations:
city: Boulder
country: United States
facility: Planned Parenthood of the Rocky Mountains
state: Colorado
city: Saint Paul
country: United States
facility: Planned Parenthood North Central States
state: Minnesota
Study officials:
References: