NCT04746014

Clearblue Pregnancy Test Lay User Usage Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 306 (actual)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Clearblue home pregnancy test (HPT) is an over the counter urine hCG (human chorionic gonadotrophin) visual pregnancy test which is intended for the detection of pregnancy. This study will assess the performance of the HPT in the hands of the lay user by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.

Detailed description

The Clearblue HPT is an over the counter urine hCG visual-read test which is intended for the detection of pregnancy. This study aims to demonstrate that the pregnancy test has the required performance characteristics in lay user testing. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged over 18 years representative of the intended user. A minimum of 300 women will be required to complete the study consisting of both pregnant and not pregnant volunteers. Each volunteer will conduct the pregnancy test using their preferred sampling method (either 'in-stream' or 'dip'). Volunteers will be evaluated against confirmed pregnancy status. Lay user comprehension of the device instructions and usability of the device will also be assessed.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clearblue Pregnancy Test	Urine Pregnancy Test

Timeline

• Start date: 2021-02-09
• Primary completion: 2021-08-03
• Completion: 2021-08-03
• First posted: 2021-02-09
• Last updated: 2021-08-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study