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| ID | Type | Description | Link |
|---|---|---|---|
| 363375 | Other Identifier | IRAS (UK) | |
| 25/WS/0165 | Other Identifier | Research Ethics Committee Approval UK | |
| 2025/0245 | Other Identifier | NHS Research & Development Approval |
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| Name | Class |
|---|---|
| NORDIC pharma (funding) | UNKNOWN |
| NHS Lothian | OTHER_GOV |
| Karolinska Institutet | OTHER |
| Karolinska University Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VEMA Patients | Women & Gender diverse individuals meeting clinical requirements for having very early medical abortion |
| |
| Staff Members | Staff members involved in using the point of care test |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Those having an abortion who meet the currently accepted clinical criteria for very early medical abortions.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacqueline Quinn | Contact | +44 0131 536 1542 | chalmers.research@ed.ac.uk | |
| Chalmers Centre Research Team Generic Email address | Contact | Chalmers.research@ed.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Sharon Cameron | NHS Lothian | Principal Investigator |
| John Reynolds-Wright | University of Edinburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Gothenberg | Not yet recruiting | Gothenburg | Sweden |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| OTHER |
| Göteborg University | OTHER |
| Sahlgrenska University Hospital | OTHER |
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| Participant Questionnaire | Other | The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine |
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| 1 year |
| Positive Predictive Value (PPV) | PPV for complete abortion of the HCG results between Day 2 and Day 4 | 4 days |
| Negative Predictive Value (NPV) | NPV for complete abortion for HCG results day 2-day 4 | 4 days |
| Binary Outcome | Whether the patients preferred follow up on Day 2-4 or on Day 7 | 7 days |
| Karolinska Institutet | Not yet recruiting | Stockholm | Sweden |
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| Chalmers Sexual Health Clinic | Recruiting | Edinburgh | United Kingdom |
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