Abortion EarlyMA-ASAPNCT05278780
Medication Abortion With Autonomous Self-Assessment Project
A study testing Screening for eligibility in people with Abortion Early, run by Gynuity Health Projects at 2 sites in United States.
Trial summary
In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early
- What is being tested?
- Screening for eligibility
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2022to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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
Show all 15Show fewer
- 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.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Planned Parenthood of the Rocky Mountains
Boulder, Colorado, 80207
Planned Parenthood North Central States
Saint Paul, Minnesota, 55114
About this study
Official title: Medication Abortion With Autonomous Self-Assessment Project: Pilot Study
In this study, the investigators propose to create and pilot-test an asynchronous medication abortion provision service.
Read the 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.
- Conditions
- Abortion Early
- Being tested
- Screening for eligibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening for eligibilityOther
Asynchronous screening
| Study group | Role | What they receive |
|---|---|---|
| Asynchronous screening | Experimental | 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. Receives: Other: Screening for eligibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Proportion of treated participants with SAE (serious adverse effects) related to the study
Measured: 12 months
Secondary outcomes (1)
Incidence of participant questions
The proportion of participants who have questions after completing the questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start1 Jun 2022
- Primary completion1 Mar 2023
- Study completion15 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Case series study
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Planned Parenthood of the Rocky Mountains, Planned Parenthood North Central States
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278780
- Sponsor's protocol ID
- 1054
- Acronym
- MA-ASAP
- Status last verified
- Mar 2023
- First submitted
- 24 Feb 2022
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Abortion With Autonomous Self-Assessment Project: Pilot Study
- ClinicalTrials.gov ID
- NCT05278780
- Acronym / sponsor ID
- MA-ASAP / 1054
- Conditions
- Abortion Early
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Stanford University, Planned Parenthood of the Rocky Mountains, Planned Parenthood North Central States
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Case series study
| Arm | Type | Receives |
|---|---|---|
| Asynchronous screening | Experimental | Other: Screening for eligibilityParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- • Has reviewed the study website
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening for eligibilityAsynchronous screening | Other | Asynchronous screening |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months
Proportion of treated participants with SAE (serious adverse effects) related to the study
1 secondary outcome
Incidence of participant questions
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening for eligibility in people with Abortion Early, run by Gynuity Health Projects at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.