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Completed

NCT Number: NCT05781061

MA-ASAP at Independent Abortion Clinics: A Demonstration Project

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

All Families Healthcare

Whitefish, Montana, 59937, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Screening for eligibility

Other

Asynchronous Screening for MA Eligibility

Primary outcomes

  1. Incidence of participant questions

    Time frame: 6 months

    The proportion of participants who have questions after completing the questionnaire and the types of questions that are asked.

  2. Proportion of participants that are followed through the study

    Time frame: 6 months

    The numbers and proportions of people who complete the questionnaire once initiated, are reached by study staff after submitting a completed questionnaire, and are ultimately followed through the study.

  3. Incidence of reported problems by site staff

    Time frame: 6 months

    Problems with the study process as reported by site staff

  4. Study site satisfaction (self-reported)

    Time frame: 6 months

    Interest on the part of study sites to continue to utilize this approach to MA provision after the study ends.

  5. Incidence of Treatment-Emergent Adverse Events

    Time frame: 6 months

    Proportion of treated participants with SAE related to the study

Secondary outcomes

  1. Efficacy of computer algorithm to determine MA eligibility

    Time frame: 6 months

    We will estimate the predictive value of this algorithm for selecting participants who were deemed eligible for MA or ultimately did receive treatment without a synchronous consultation or facility-based tests

Sponsors and collaborators

Lead sponsor

Gynuity Health Projects

Other

Collaborators

  • All Families Healthcare

Registry information

Official study title

Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 23, 2023
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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