Quick point-of-care hormone testing to manage very early medical abortion
Point of Care Testing for Human Chorionic Gonadotropin (HCG) to Improve Access to Very Early Medical Abortion and Simplify the Follow up Process
This will see if a quick point-of-care blood test can detect pregnancy hormone changes sooner than the usual Day 7 for people having a medical abortion before six weeks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Ages | 16 Years to 55 Years |
| Sex | Female |
| Sponsor | University of Edinburgh Academic / other |
| Locations | 3 sites (Gothenburg and 2 other locations) |
| Trial ID | NCT07417787 on ClinicalTrials.gov |
What this trial studies
This observational study follows people having very early medical abortion (under six weeks by last menstrual period) and uses a point-of-care device to measure serum hCG earlier than the standard follow-up. Participants provide blood at baseline (Day 0), at Day 2–4, and at Day 7 after mifepristone and complete brief questionnaires. Investigators will compare point-of-care results with standard laboratory hCG to determine whether earlier measurements reliably indicate treatment success. The study is run at academic and NHS sites including University of Edinburgh, NHS Lothian, Karolinska Institutet, and University of Gothenburg.
Who should consider this trial
Good fit: People with a positive pregnancy test under six weeks by LMP who choose very early medical abortion, have no signs or high risk of ectopic pregnancy, can give blood, and can attend follow-up visits.
Not a fit: People with pain or bleeding, significant risk factors or suspicious features for ectopic pregnancy, an intrauterine device in place, or who cannot provide blood or attend follow-up are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, this could let people get earlier reassurance of treatment success and potentially reduce clinic visits and anxiety.
How similar studies have performed: Serial serum hCG measurement is an established way to confirm abortion success, but using point-of-care hCG devices this early in very early medical abortion is relatively novel and not widely proven.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Gothenburg and 2 other locations
- University of Gothenberg — Gothenburg, Sweden (Not_yet_recruiting)
- Karolinska Institutet — Stockholm, Sweden (Not_yet_recruiting)
- Chalmers Sexual Health Clinic — Edinburgh, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Sharon Cameron — NHS Lothian
- Study coordinator: Jacqueline Quinn
- Email: chalmers.research@ed.ac.uk
- Phone: +44 0131 536 1542
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.