NCT04043169

Clearblue Pregnancy Test - Lay User Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 204 (actual)
• Sponsor: SPD Development Company Limited · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: —

Summary

The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users 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 product is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. The test is indicated for use from 6 days before the day of the missed period (5 days before the day of the expected period). The test is intended for home use. This study aims to demonstrate that the Pregnancy Test has the required performance characteristics in lay-user testing, and when testing samples provided by lay-users. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged between 18 and 45 representative of the intended user. A minimum of 204 volunteers will be required to complete the study. The study site will aim to recruit an equal number of pregnant and not-pregnant volunteers (a minimum of 102 of each). Each volunteer will conduct the pregnancy test using both the 'in stream' and 'dip' method of sampling. Volunteer results will be evaluated against confirmed pregnancy status.

Conditions

• Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Clearblue pregnancy test	Urine pregnancy test

Timeline

• Start date: 2019-07-30
• Primary completion: 2019-11-30
• Completion: 2019-12-31
• First posted: 2019-08-02
• Last updated: 2020-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study