Pregnancy Related Clinical Trial
Official title:
Evaluation of Home Pregnancy Test by Lay Users Study
Verified date | February 2021 |
Source | SPD Development Company Limited |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a performance evaluation study to assess the performance of a home pregnancy test (HPT) in the hands of lay users by comparing their results, when used according to the Instructions for Use (IFU), to (a) the lay user confirmed pregnancy status, as determined by a CE marked product, and (b) to trained technicians testing the same urine samples. The study will also assess the lay user's ability to correctly read results from randomised standards, in addition to leaflet comprehension and product ease of use.
Status | Completed |
Enrollment | 129 |
Est. completion date | November 4, 2020 |
Est. primary completion date | November 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Willing to give informed consent - Willing to conduct a personal home pregnancy test and reveal their pregnancy status - Seeking to conceive, wishing to conduct a pregnancy test or having recently found out they are pregnant Exclusion Criteria: - Currently or previously employed by SPD, Abbott, Alere, Unipath, P&G or affiliates - Has an immediate relative currently or previously (within last 5 years) employed by SPD, Abbott, Alere, Unipath or P&G, or affiliates - Healthcare professionals (HCP's) with professional experience either using lateral flow-based devices or conducting near patient testing - If pregnant, known to be beyond the first trimester (defined as last menstrual period, LMP +13 weeks) - aken a hormonal preparation containing hCG in the last month, e.g. Pregnyl ® - Has previously taken part in this study - Seen the product within the past 6 months Immediate relatives are defined as parents, children, siblings or partner/spouse |
Country | Name | City | State |
---|---|---|---|
United Kingdom | SPD Development Company Ltd | Bedford | Bedfordshire |
Lead Sponsor | Collaborator |
---|---|
SPD Development Company Limited |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Agreement with pregnancy status | The accuracy of the investigational HPT will be calculated against the confirmed pregnancy status of the sample. The corresponding 95% confidence interval will also be calculated for the measure. | 3 months | |
Secondary | Agreement with technician results | The agreement between the lay-user and technician results when both testing the same sample with the investigational HPT as per the IFU. The corresponding 95% confidence interval will also be calculated for the measure. | 3 months | |
Secondary | Comprehension of instructions for use | The percentage number of correct answers in the IFU comprehension exercise | 3 months | |
Secondary | Ease of product use | The cumulative Likert scores for ease of use questions on the device usability questionnaire will be calculated, using a 7 point likert scale, where 1 is equivalent to very easy and 7 is equivalent to very difficult. | 3 months | |
Secondary | Ability to read result | The agreement between the lay-user read of a investigational HPT tested with a spiked standard against the expected result of the spiked standard. The corresponding 95% confidence interval will also be calculated. | 3 months |
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