Point of Care Tests in the Management of Very Early Medical Abortion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood test, Participant Questionnaire.
- Who it may be relevant to
- Registry conditions: Abortion Early. Basic parameters: 16 years — 55 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Point of Care Testing for Human Chorionic Gonadotropin (HCG) to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process
Overview
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.
Interventions
- 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
Primary outcome measures
- Sensitivity [Time frame: Day 0, Day 2-4 and Day 7]
- Specificity [Time frame: 7 days]
Secondary outcome measures (4)
- Usability questionnaire for Human Chorionic Gonadotropin (HCG) POCT verification using Likert scale. [Time frame: 1 year]
- Positive Predictive Value (PPV) [Time frame: 4 days]
- Negative Predictive Value (NPV) [Time frame: 4 days]
- Binary Outcome [Time frame: 7 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 2 centers
- University of Gothenberg — Gothenburg
- Karolinska Institutet — Stockholm
United Kingdom · 1 center
- Chalmers Sexual Health Clinic — Edinburgh
Identifiers
NCT: NCT07417787 · AC25163 · 363375 · 25/WS/0165 · 2025/0245