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Completed

NCT Number: NCT05278780

Medication Abortion With Autonomous Self-Assessment Project

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Planned Parenthood of the Rocky Mountains, Boulder, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Screening for eligibility

Other

Asynchronous screening

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: 12 months

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

Secondary outcomes

  1. Incidence of participant questions

    Time frame: 12 months

    The proportion of participants who have questions after completing the questionnaire

Other outcomes

  1. Proportion of participants who liked the service

    Time frame: 12 months

    Participant satisfaction upon exiting study evaluated using a participant satisfaction survey questionnaire

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

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

Registry information

Official study title

Medication Abortion With Autonomous Self-Assessment Project: Pilot Study

Acronym: MA-ASAP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2022
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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