Point of Care Tests in the Management of Very Early Medical Abortion

University of Edinburgh130 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

130

Conditions

Abortion Early

Interventions

Blood testDIAGNOSTIC_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

Participant QuestionnaireOTHER

The investigators will administer participant questionnaires to both staff and patients to understand opinions on the point of care test machine

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (3)

University of Gothenberg

Gothenburg, Sweden

NOT_YET_RECRUITING

Karolinska Institutet

Stockholm, Sweden

NOT_YET_RECRUITING

Chalmers Sexual Health Clinic

Edinburgh, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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