Pregnancy Testing Clinical Trial
Official title:
Home Pregnancy Test Evaluation Study
This study will evaluate consumer preference and consumer results from a number of
commercially available home pregnancy tests.
The study is being conducted as a formal assessment home pregnancy tests sold in Western
Europe.
The study will be conducted in two parts:
Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different
tests being evaluated) in their own home to gain usability data. All products will be used
according to their instructions for use which, where required, will be translated into
English prior to the study start. A study questionnaire will be completed after each test is
used.
Part 2: The volunteers will attend the study site soon after completing their last home test
and be required to read randomised results of tests conducted by study technicians (pregnant
and not pregnant) to gain an understanding of their ability to correctly read results of the
tests. The technician will also read and record the test results to enable both the
laboratory agreement (technician read) and the consumer readability to be determined and
compared for each product.
Each volunteer will be required to provide a urine sample for determining pregnancy status
and quantitative urinary hormone measurement (this is done to confirm the result obtained at
home using the HPTs).
At the end of the testing period the volunteers will also be asked to rank the four products
they have used in the study, based on a series of statements regarding usability and
readability of the tests
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