PregnancyNCT06893484
Assessment of Early Pregnancy MAB Completion
An observational study of Pregnancy and Abortion Early, run by University of Washington at 3 sites in United States.
Trial summary
This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pregnancy, Abortion Early
- What is being tested?
- Weekly high-sensitivity urine pregnancy tests
- How many people
- 400 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Mar 2025to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will enroll patients who meet the inclusion criteria at clinical sites in Washington, Georgia, and Maryland.
Who may be able to join
- Pregnant person with early pregnancy ≤42 days
- Eligible and consented to a medication abortion
- Have access to receiving text messages and the internet
- Able to read and understand English
Who cannot join
- Privacy or safety concerns about filling out the surveys
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Carafem
Atlanta, Georgia, 30309
Carafem
Chevy Chase, Maryland, 20815
Cedar River Clinics
Renton, Washington, 98055
About this study
Official title: Assessing Completion of Medication Abortion for Very Early Pregnancies
This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Enrolled participants will take take weekly pregnancy tests and complete weekly questionnaires on their pregnancy symptoms for 4 weeks after their medication abortion.
- Conditions
- Pregnancy, Abortion Early
- Being tested
- Weekly high-sensitivity urine pregnancy tests
- Keywords
- very early pregnancy, pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly high-sensitivity urine pregnancy testsDiagnostic test
Participants will take a high-sensitivity urine pregnancy test at home weekly for up to 4 weeks compared to the taking just one home urine pregnancy test at 4-5 weeks. Participants will also complete short weekly questionnaires on their pregnancy symptoms and follow-up care.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Early Pregnancy | Participants with early pregnancy ≤ 42 days by last menstrual period or ultrasound undergoing a medication abortion will be enrolled. Receives: Diagnostic Test: Weekly high-sensitivity urine pregnancy tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with negative high-sensitivity urine pregnancy test at 2 weeks
To estimate the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 2 weeks after taking Mifepristone and compare this proportion to the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 4 weeks
Measured: From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires
Secondary outcomes (1)
Time to resolution of pregnancy symptoms
To compare the timing of pregnancy symptom resolution per patient report on weekly questionnaires with the timing of a negative high-sensitivity urine pregnancy test result
Measured: From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start13 Mar 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lyndsey Benson, University of Washington
- Investigators
- Lyndsey Benson, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893484
- Sponsor's protocol ID
- STUDY00022025
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to study IPD will not be shared for this study due to the sensitive, private nature of the clinical care received by participants. Participant safety and confidentiality is of utmost importance for this study.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Completion of Medication Abortion for Very Early Pregnancies
- ClinicalTrials.gov ID
- NCT06893484
- Acronym / sponsor ID
- STUDY00022025
- Conditions
- Pregnancy, Abortion Early
- Keywords
- very early pregnancy, pregnancy test
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Mar 2025 (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.
This is a prospective study to evaluate if successful completion of a medication abortion in patients with very early pregnancy can be detected with a urine pregnancy test at 2 weeks instead of 4 weeks. Additionally, the resolution of pregnancy symptoms in these patients will be characterized. Enrolled participants will take take weekly pregnancy tests and complete weekly questionnaires on their pregnancy symptoms for 4 weeks after their medication abortion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Early Pregnancy | – | Diagnostic Test: Weekly high-sensitivity urine pregnancy testsParticipants with early pregnancy ≤ 42 days by last menstrual period or ultrasound undergoing a medication abortion will be enrolled. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll patients who meet the inclusion criteria at clinical sites in Washington, Georgia, and Maryland.
Key inclusion criteria (4 listed)
- Pregnant person with early pregnancy ≤42 days
- Eligible and consented to a medication abortion
- Have access to receiving text messages and the internet
- Able to read and understand English
Key exclusion criteria (1 listed)
- Privacy or safety concerns about filling out the surveys
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 |
|---|---|---|
| Weekly high-sensitivity urine pregnancy testsParticipants will take a high-sensitivity urine pregnancy test at home weekly for up to 4 weeks compared to the taking just one home urine pregnancy test at 4-5 weeks. Participants will also complete short weekly questionnaires on their pregnancy symptoms and follow-up care. | Diagnostic test | Participants with Early Pregnancy |
Primary outcome
Proportion of participants with negative high-sensitivity urine pregnancy test at 2 weeks
Time frame: From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires
To estimate the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 2 weeks after taking Mifepristone and compare this proportion to the proportion of negative high-sensitivity urine pregnancy tests in participants with very early pregnancy and a complete abortion at 4 weeks
1 secondary outcome
Time to resolution of pregnancy symptoms
Time frame: From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. Access to study IPD will not be shared for this study due to the sensitive, private nature of the clinical care received by participants. Participant safety and confidentiality is of utmost importance for this study.
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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.
Lyndsey Benson, MD, MS principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Abortion Early, run by University of Washington at 3 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 4 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: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
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?
Proportion of participants with negative high-sensitivity urine pregnancy test at 2 weeks (time frame: From time of taking Mifepristone to negative pregnancy test or 4-5 weeks of questionnaires). 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 8 May 2026.