Abortion EarlyPOCT VEMANCT07417787
Point of Care Tests in the Management of Very Early Medical Abortion
An observational study of Abortion Early, run by University of Edinburgh at 3 sites in 2 countries.
Trial summary
This study will investigate the use of a point of care test in patients who are having an abortion at a gestation of <6 weeks (known as a very early medical abortion). These patients have pregnancy hormone level checked at Day 0 and Day 7 to see if treatment has worked. Read more about this study
- Who is it for?
- Ages 16 to 55 years, women only
- Conditions the study is for
- Abortion Early
- What is being tested?
- Blood test and Participant Questionnaire
- How many people
- 130 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 23 Apr 2026to Feb 2028
- 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 16 to 55 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Those having an abortion who meet the currently accepted clinical criteria for very early medical abortions.
Who may be able to join
- Positive pregnancy test
- Less than six weeks gestation based upon Last Menstrual Period (LMP)
- No evidence of definite intrauterine pregnancy on ultrasound
- No signs or symptoms or significant risk factors for ectopic
- Wish to proceed to VEMA (Very Early Medical Abortion)
- Available for usual clinical follow up
- Willing to attend for serum Human Chorionic Gonadotropin (HCG) on two occasions Day 2-4 and Day 7 post mifepristone
- Written informed consent
Who cannot join
- Pain and/or bleeding
- Significant risk factors for ectopic (previous ectopic, sterilisation, tubal disease, intrauterine device in situ)
- Suspicious features for ectopic on ultrasound (adnexal mass, moderate free fluid)
- Unable to provide blood sample
- Lack of Capacity to consent
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Chalmers Centre Research Team Generic Email address contact
3 sites in 2 countries
Sweden2 sites, 2 recruiting
- Not yet recruiting
University of Gothenberg
Gothenburg
Tagrid Jar-Allah, +46 031-343 42 16, tagrid.jar-allah@gu.se
- Not yet recruiting
Karolinska Institutet
Stockholm
Karin Rebecka Brandell, +46 08-524 864 00, karin.brandell@ki.se
United Kingdom1 site, 1 recruiting
- Recruiting
Chalmers Sexual Health Clinic
Edinburgh
Jacqueline Quinn, +4401315361542, chalmers.research@ed.ac.uk
About this study
Official title: Point of Care Testing for Human Chorionic Gonadotropin (HCG) to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process
This study will investigate the use of a point of care test in patients who are having an abortion at a gestation of <6 weeks (known as a very early medical abortion). These patients have pregnancy hormone level checked at Day 0 and Day 7 to see if treatment has worked. The investigators plan to use a point of care test machine to see if it is possible to check pregnancy hormone level earlier than Day 7.
- Conditions
- Abortion Early
- Being tested
- Blood test, Participant Questionnaire
- Keywords
- VEMA, Very Early Medical Abortion, point of care test, POCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Patients will undergo one additional blood test than is usual with standard care, to measure Human Chorionic Gonadotropin (HCG) level which will be analysed on a point of care test machine and in the lab
Participant QuestionnaireOther
The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine
| Study group | Role | What they receive |
|---|---|---|
| VEMA Patients | Women \& Gender diverse individuals meeting clinical requirements for having very early medical abortion Receives: Diagnostic Test: Blood test; Other: Participant Questionnaire | |
| Staff Members | Staff members involved in using the point of care test Receives: Other: Participant Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day2-4 compared with percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day 7
Measured: Day 0, Day 2-4 and Day 7
Specificity
The Specificity of percentage HCG drop between Day 0 and Day 2-4, compared with specificity of percentage HCG drop between Day 0 and Day 7
Measured: 7 days
Secondary outcomes (4)
Usability questionnaire for Human Chorionic Gonadotropin (HCG) POCT verification using Likert scale.
Assess how useful, easy to use, easy to learn to use and acceptable the point of care test is to staff members. Scale will be a minimum of 1 and maximum of 5, with 1 relating to strongly disagree and 5 relating strongly agree to a range of positive statements, meaning a higher score would be a better outcome
Measured: 1 year
Positive Predictive Value (PPV)
PPV for complete abortion of the HCG results between Day 2 and Day 4
Measured: 4 days
Negative Predictive Value (NPV)
NPV for complete abortion for HCG results day 2-day 4
Measured: 4 days
Binary Outcome
Whether the patients preferred follow up on Day 2-4 or on Day 7
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start23 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2028 (estimated)
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.
- More trials run by University of EdinburghThe 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NORDIC pharma (funding), NHS Lothian, Karolinska Institutet, Karolinska University Hospital, Göteborg University, Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Sharon Cameron, Principal investigator, NHS LothianJohn Reynolds-Wright, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417787
- Sponsor's protocol ID
- AC25163
- Other IDs
- 363375, 25/WS/0165, 2025/0245
- Acronym
- POCT VEMA
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2026
- Last updated
- 3 Jun 2026
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Testing for Human Chorionic Gonadotropin (HCG) to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process
- ClinicalTrials.gov ID
- NCT07417787
- Acronym / sponsor ID
- POCT VEMA / AC25163
- Conditions
- Abortion Early
- Keywords
- VEMA, Very Early Medical Abortion, point of care test, POCT
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NORDIC pharma (funding), NHS Lothian, Karolinska Institutet, Karolinska University Hospital, Göteborg University, Sahlgrenska University Hospital
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 18 Feb 2026 (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 study will investigate the use of a point of care test in patients who are having an abortion at a gestation of <6 weeks (known as a very early medical abortion). These patients have pregnancy hormone level checked at Day 0 and Day 7 to see if treatment has worked. The investigators plan to use a point of care test machine to see if it is possible to check pregnancy hormone level earlier than Day 7.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEMA Patients | – | Diagnostic Test: Blood test, Other: Participant QuestionnaireWomen \& Gender diverse individuals meeting clinical requirements for having very early medical abortion |
| Staff Members | – | Other: Participant QuestionnaireStaff members involved in using the point of care test |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Those having an abortion who meet the currently accepted clinical criteria for very early medical abortions.
Key inclusion criteria (8 listed)
- Positive pregnancy test
- Less than six weeks gestation based upon Last Menstrual Period (LMP)
- No evidence of definite intrauterine pregnancy on ultrasound
- No signs or symptoms or significant risk factors for ectopic
- Wish to proceed to VEMA (Very Early Medical Abortion)
Key exclusion criteria (5 listed)
- Pain and/or bleeding
- Significant risk factors for ectopic (previous ectopic, sterilisation, tubal disease, intrauterine device in situ)
- Suspicious features for ectopic on ultrasound (adnexal mass, moderate free fluid)
- Unable to provide blood sample
- Lack of Capacity to consent
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 |
|---|---|---|
| Blood testPatients will undergo one additional blood test than is usual with standard care, to measure Human Chorionic Gonadotropin (HCG) level which will be analysed on a point of care test machine and in the lab | Diagnostic test | VEMA Patients |
| Participant QuestionnaireThe investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine | Other | Staff Members, VEMA Patients |
Primary outcome
Sensitivity
Time frame: Day 0, Day 2-4 and Day 7
Sensitivity of percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day2-4 compared with percentage change in Human Chorionic Gonadotropin (HCG) between Day 0 and Day 7
Specificity
Time frame: 7 days
The Specificity of percentage HCG drop between Day 0 and Day 2-4, compared with specificity of percentage HCG drop between Day 0 and Day 7
4 secondary outcomes
Usability questionnaire for Human Chorionic Gonadotropin (HCG) POCT verification using Likert scale.
Time frame: 1 year
Positive Predictive Value (PPV)
Time frame: 4 days
Negative Predictive Value (NPV)
Time frame: 4 days
Binary Outcome
Time frame: 7 days
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 3 Jun 2026.
- 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.
Chalmers Centre Research Team Generic Email address contact
Sharon Cameron principal investigator
NHS Lothian
John Reynolds-Wright principal investigator
University of Edinburgh
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abortion Early, run by University of Edinburgh at 3 sites in 2 countries.
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 8 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Jun 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 Sweden, United Kingdom. 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?
Contact Jacqueline Quinn (+44 0131 536 1542, chalmers.research@ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Day 0, Day 2-4 and Day 7). The study lists 2 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 3 Jun 2026.