RecruitingNCT07417787

Point of Care Tests in the Management of Very Early Medical Abortion

Point of Care Testing for HCG to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process


Sponsor

University of Edinburgh

Enrollment

130 participants

Start Date

Feb 23, 2026

Study Type

OBSERVATIONAL

Conditions

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 their pregnancy hormone level checked at Day 0 and Day 7 to see if their treatment has worked. We plan to use a point of care test machine to see if we can check their pregnancy hormone level earlier than Day 7.


Eligibility

Sex: FEMALEMin Age: 16 YearsMax Age: 55 Years

Inclusion Criteria8

  • Positive pregnancy test
  • Less than six weeks gestation based upon LMP
  • No evidence of definite intrauterine pregnancy on ultrasound
  • No signs or symptoms or significant risk factors for ectopic
  • Wish to proceed to VEMA
  • Available for usual clinical follow up
  • Willing to attend for serum HCG on two occasions Day 2-4 and Day 7 post mifepristone
  • Written informed consent

Exclusion Criteria5

  • 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

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Interventions

DIAGNOSTIC_TESTBlood test

Patients will undergo one additional blood test than is usual with standard care, to measure HCG level which will be analysed on a point of care test machine and in the lab

OTHERParticipant Questionnaire

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


Locations(3)

University of Gothenberg

Gothenburg, Sweden

Karolinska Institutet

Stockholm, Sweden

Chalmers Sexual Health Clinic

Edinburgh, United Kingdom

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NCT07417787


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