An observational study in Abortion Early, sponsored by University of Edinburgh. Recruiting at 3 sites in 2 countries. Open to female participants aged 16 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by University of Edinburgh · Observational
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.
University of Edinburgh is the lead sponsor of 393 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Those having an abortion who meet the currently accepted clinical criteria for very early medical abortions.
Exclusion Criteria:
Women \& Gender diverse individuals meeting clinical requirements for having very early medical abortion
Diagnostic Test: Blood test · Other: Participant Questionnaire
Staff members involved in using the point of care test
Other: Participant Questionnaire
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
The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine
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
Time frame: 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
Time frame: 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
Time frame: 1 year
Positive Predictive Value (PPV)
PPV for complete abortion of the HCG results between Day 2 and Day 4
Time frame: 4 days
Negative Predictive Value (NPV)
NPV for complete abortion for HCG results day 2-day 4
Time frame: 4 days
Binary Outcome
Whether the patients preferred follow up on Day 2-4 or on Day 7
Time frame: 7 days
Plan to share: No
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University of Edinburgh