Abortion EarlyNCT05781061
MA-ASAP at Independent Abortion Clinics: A Demonstration Project
A study testing Screening for Eligibility in people with Abortion Early, run by Gynuity Health Projects at 1 site in United States.
Trial summary
In this study, the investigators propose to conduct a parallel study to MA-ASAP (ClinicalTrials.gov Identifier: NCT05278780) at an independent clinic. 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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2023to 15 Jun 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
- 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
Show all 13Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Abortion With Autonomous Self-Assessment Project 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.
Read the 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.
- 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 for MA Eligibility
| 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 participant questions
The proportion of participants who have questions after completing the questionnaire and the types of questions that are asked.
Measured: 6 months
Proportion of participants that are followed through the study
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.
Measured: 6 months
Incidence of reported problems by site staff
Problems with the study process as reported by site staff
Measured: 6 months
Study site satisfaction (self-reported)
Interest on the part of study sites to continue to utilize this approach to MA provision after the study ends.
Measured: 6 months
Incidence of Treatment-Emergent Adverse Events
Proportion of treated participants with SAE related to the study
Measured: 6 months
Secondary outcomes (1)
Efficacy of computer algorithm to determine MA eligibility
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start16 Feb 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 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
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- All Families Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781061
- Sponsor's protocol ID
- 1059
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- 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 at Independent Abortion Clinics: A Demonstration Project
- ClinicalTrials.gov ID
- NCT05781061
- Acronym / sponsor ID
- 1059
- Conditions
- Abortion Early
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- All Families Healthcare
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 23 Mar 2023 (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 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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 (13 listed)
- 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
Key exclusion criteria (0 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 for MA Eligibility | Other | Asynchronous Screening |
Primary outcome
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.
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.
Incidence of reported problems by site staff
Time frame: 6 months
Problems with the study process as reported by site staff
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.
Incidence of Treatment-Emergent Adverse Events
Time frame: 6 months
Proportion of treated participants with SAE related to the study
1 secondary outcome
Efficacy of computer algorithm to determine MA eligibility
Time frame: 6 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.
1 site 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 1 site 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 13 inclusion and 0 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 1 site 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 participant questions (time frame: 6 months). The study lists 5 primary outcomes in all. 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.