Clinical trial NCT05781061: MA-ASAP at Independent Abortion Clinics: A Demonstration Project
Official title: Medication Abortion With Autonomous Self-Assessment Project at Independent Abortion Clinics: A Demonstration Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion Early
Lead sponsor: Gynuity Health Projects
Sponsor class: OTHER
Collaborators: name: All Families Healthcare
First posted: 2023-03-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of participant questions
timeFrame: 6 months
measure: Proportion of participants that are followed through the study
timeFrame: 6 months
measure: Incidence of reported problems by site staff
timeFrame: 6 months
measure: Study site satisfaction (self-reported)
timeFrame: 6 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 6 months
Secondary outcomes:
measure: Efficacy of computer algorithm to determine MA eligibility
timeFrame: 6 months
Other outcomes:
Locations:
city: Whitefish
country: United States
facility: All Families Healthcare
state: Montana
Study officials:
References: