Abortion Early
Conditions
Keywords
VEMA, Very Early Medical Abortion, point of care test, POCT
Brief summary
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_TESTBlood 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
The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine
Sponsors
University of Edinburgh
NORDIC pharma (funding)
NHS Lothian
Karolinska Institutet
Karolinska University Hospital
Göteborg University
Sahlgrenska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 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 |
| Specificity | 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
| Measure | Time frame | Description |
|---|---|---|
| Usability questionnaire for Human Chorionic Gonadotropin (HCG) POCT verification using Likert scale. | 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 |
| Positive Predictive Value (PPV) | 4 days | PPV for complete abortion of the HCG results between Day 2 and Day 4 |
| Negative Predictive Value (NPV) | 4 days | NPV for complete abortion for HCG results day 2-day 4 |
| Binary Outcome | 7 days | Whether the patients preferred follow up on Day 2-4 or on Day 7 |
Countries
Sweden, United Kingdom
Contacts
CONTACTJacqueline Quinn
CONTACTChalmers Centre Research Team Generic Email address
PRINCIPAL_INVESTIGATORSharon Cameron
NHS Lothian
PRINCIPAL_INVESTIGATORJohn Reynolds-Wright
University of Edinburgh
Outcome results
None listed