NCT07417787

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
20mo left

Started Apr 2026

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Apr 2026Feb 2028

First Submitted

Initial submission to the registry

February 10, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

June 3, 2026

Status Verified

June 1, 2026

Enrollment Period

9 months

First QC Date

February 10, 2026

Last Update Submit

June 1, 2026

Conditions

Abortion Early

Keywords

VEMAVery Early Medical Abortionpoint of care testPOCT

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Usability questionnaire for Human Chorionic Gonadotropin (HCG) POCT verification using Likert scale.

    1 year

  • Positive Predictive Value (PPV)

    4 days

  • Negative Predictive Value (NPV)

    4 days

  • Binary Outcome

    7 days

Study Arms (2)

VEMA Patients

Women \& Gender diverse individuals meeting clinical requirements for having very early medical abortion

Diagnostic Test: Blood testOther: Participant Questionnaire

Staff Members

Staff members involved in using the point of care test

Other: Participant Questionnaire

Interventions

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

VEMA Patients
Participant QuestionnaireOTHER

The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine

Staff MembersVEMA Patients

Eligibility Criteria

Age16 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Gothenberg

Gothenburg, Sweden

NOT YET RECRUITING

Karolinska Institutet

Stockholm, Sweden

NOT YET RECRUITING

Chalmers Sexual Health Clinic

Edinburgh, United Kingdom

RECRUITING

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sharon Cameron

    NHS Lothian

    PRINCIPAL INVESTIGATOR

  • John Reynolds-Wright

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Quinn

CONTACT

+44 0131 536 1542chalmers.research@ed.ac.uk

Chalmers Centre Research Team Generic Email address

CONTACT

Chalmers.research@ed.ac.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2026

First Posted

February 18, 2026

Study Start

April 23, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

June 3, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)GB(1)