Home Pregnancy Test Evaluation Study
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|ClinicalTrials.gov Identifier: NCT03589534|
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : November 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Testing||Diagnostic Test: home pregnancy test||Not Applicable|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Home Pregnancy Test Evaluation Study|
|Actual Study Start Date :||June 6, 2018|
|Actual Primary Completion Date :||August 13, 2018|
|Actual Study Completion Date :||August 13, 2018|
Diagnostic Test: home pregnancy test
Each participant will use 4 different home pregnancy tests
- 1. Demonstration of volunteer preference for a HPTs. [ Time Frame: 1 week ]• The cumulative scores on a 7-point likert scale for ease of use questions on the device usability at home questionnaire, where 1 equals very good and 7 equals very poor for each attribute.
- 2. Demonstration of volunteer readability of HPTs [ Time Frame: 1 week ]• The cumulative scores on a 7-point likert scale for readability questions on the device readability at SPD questionnaire, where 1 equals very easy and 7 equals very difficult for each attribute.
- 3. Demonstration of consumer preference for a HPT [ Time Frame: 1 week ]• The ranking of each Home Pregnancy Test in order of preference
- 1. Accuracy of reading [ Time Frame: 1 week ]The per cent agreement (accuracy) between the result read by the volunteer and true result for each standard tested (i.e 0 hCG will be not pregnant and 25mIU/ml hCG will be pregnant) for each Home pregnancy test evaluated.
- Agreement of reading [ Time Frame: 1 week ]The agreement between volunteer home pregnancy test results and those of a technician testing the same urine standard (volunteer vs. technician test result)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589534
|SPD Development Company Ltd.|
|Bedford, Bedfordshire, United Kingdom, MK44 3UP|