Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07417787

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Abortion Early

Age range

16 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

University of Gothenberg, Gothenburg, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Diagnostic 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 Questionnaire

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

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

    Time frame: 1 year

    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

  2. Positive Predictive Value (PPV)

    Time frame: 4 days

    PPV for complete abortion of the HCG results between Day 2 and Day 4

  3. Negative Predictive Value (NPV)

    Time frame: 4 days

    NPV for complete abortion for HCG results day 2-day 4

  4. Binary Outcome

    Time frame: 7 days

    Whether the patients preferred follow up on Day 2-4 or on Day 7

Study contacts

Contact information is provided by the study sponsor or research team.

Chalmers Centre Research Team Generic Email address

CONTACT

[email protected]

Jacqueline Quinn

CONTACT

[email protected]

+44 0131 536 1542

Sponsors and collaborators

Lead sponsor

University of Edinburgh

Other

Collaborators

  • Göteborg University
  • Karolinska Institutet
  • Karolinska University Hospital
  • NHS Lothian
  • NORDIC pharma (funding)
  • Sahlgrenska University Hospital

Registry information

Official study title

Point of Care Testing for Human Chorionic Gonadotropin (HCG) to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process

Acronym: POCT VEMA

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 18, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.