Point of Care Tests in the Management of Very Early Medical Abortion (POCT VEMA)

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.

Study Overview

• Status: Recruiting
• Conditions: Abortion Early
• Intervention / Treatment: Diagnostic test: Blood test; Other: Participant Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 130

Contacts and Locations

• Study Contact: Name: Jacqueline Quinn; Phone Number: +44 0131 536 1542; Email: chalmers.research@ed.ac.uk
• Study Contact Backup: Name: Chalmers Centre Research Team Generic Email address; Email: Chalmers.research@ed.ac.uk

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Not yet recruiting
    • University of Gothenberg
    • Contact: Tagrid Jar-Allah; Phone Number: +46 031-343 42 16; Email: tagrid.jar-allah@gu.se
  • Stockholm, Sweden
    • Not yet recruiting
    • Karolinska Institutet
    • Contact: Karin Rebecka Brandell; Phone Number: +46 08-524 864 00; Email: karin.brandell@ki.se
• United Kingdom
  • Edinburgh, United Kingdom
    • Recruiting
    • Chalmers Sexual Health Clinic
    • Contact: Jacqueline Quinn; Phone Number: +4401315361542; Email: chalmers.research@ed.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Those having an abortion who meet the currently accepted clinical criteria for very early medical abortions.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VEMA Patients; Women & Gender diverse individuals meeting clinical requirements for having very early medical abortion	Diagnostic test: Blood 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; Other: Participant Questionnaire; The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine
Staff Members; Staff members involved in using the point of care test	Other: Participant Questionnaire; The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive Predictive Value (PPV)	PPV for complete abortion of the HCG results between Day 2 and Day 4	4 days
Negative Predictive Value (NPV)	NPV for complete abortion for HCG results day 2-day 4	4 days
Binary Outcome	Whether the patients preferred follow up on Day 2-4 or on Day 7	7 days
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	1 year

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: Karolinska University Hospital; Karolinska Institutet; Göteborg University; NHS Lothian; NORDIC pharma (funding); Sahlgrenska University Hospital
• Investigators: Principal Investigator: Sharon Cameron, NHS Lothian; Principal Investigator: John Reynolds-Wright, University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: POCT; point of care test; VEMA; Very Early Medical Abortion
• Additional Relevant MeSH Terms: Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests
• Other Study ID Numbers: AC25163; 363375 (Other Identifier: IRAS (UK)); 25/WS/0165 (Other Identifier: Research Ethics Committee Approval UK); 2025/0245 (Other Identifier: NHS Research & Development Approval)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No