NCT03589534

Home Pregnancy Test Evaluation Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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

Conditions

• Pregnancy Testing

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	home pregnancy test	Each participant will use 4 different home pregnancy tests

Timeline

• Start date: 2018-06-06
• Primary completion: 2018-08-13
• Completion: 2018-08-13
• First posted: 2018-07-18
• Last updated: 2018-11-09

Locations

1 site across 1 country: United Kingdom