Health TrialsbyHealthPanel

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

ConditionAbortion Early
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age16-55
SponsorUniversity of Edinburgh

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Those having an abortion who meet the currently accepted clinical criteria for very early medical abortions.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

  • Participant Questionnaire

    Other intervention

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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: VEMA Patients2 interventions
Group B: Staff Members1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

1

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
2

Positive Predictive Value (PPV)

PPV for complete abortion of the HCG results between Day 2 and Day 4

Time frame
4 days
3

Negative Predictive Value (NPV)

NPV for complete abortion for HCG results day 2-day 4

Time frame
4 days
4

Binary Outcome

Whether the patients preferred follow up on Day 2-4 or on Day 7

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Edinburgh

Lead sponsor

NORDIC pharma (funding)

Collaborator

NHS Lothian

Collaborator

Karolinska Institutet

Collaborator

Karolinska University Hospital

Collaborator

Göteborg University

Collaborator

Sahlgrenska University Hospital

Collaborator

Source ClinicalTrials.gov
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