Clearblue Pregnancy Test Lay User Usage Study

Completed

• Conditions: Pregnancy

• Registration Number: NCT04746014
• Lead Sponsor: SPD Development Company Limited

Brief 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.

Study Timeline

• Study First Submitted: 2021-02-04
• Study First Submitted QC: 2021-02-04
• Study Start: 2021-02-09
• Study First Posted: 2021-02-09
• Status Verified: 2021-08
• Primary Completion: 2021-08-03
• Study Completion: 2021-08-03
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 306

Inclusion Criteria

• Female
• Aged 18 and over
• Interested in conducting a personal pregnancy test to determine or confirm their pregnancy status
• Willing to reveal their pregnancy status
• Willing to provide a blood sample
• Willing to give informed consent

Exclusion Criteria

• Significant affiliation with SPD
• Used the investigational pregnancy test previously
• Qualified or trainee healthcare professional (HCP)
• Has professional experience (in current or previous job) of using dipstick type tests or lateral flow devices
• Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks)
• Has a medical condition that means that it is not appropriate to give a blood sample

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Clearblue Pregnancy Test	3 days	Number of pregnancy tests in agreement with pregnancy status

Secondary Outcome Measures

Name	Time	Method
Comprehension of Instructions for Use	1 day	Number of volunteers who answer each comprehension question correctly
Co-ordinator Agreement	1 day	Number of lay users who record the same pregnancy test result as a trained study co-ordinator
Device Usability	1 day	Number of volunteers who record the device as easy to use

Trial Locations

Locations (1)

WCCT; 🇺🇸 Cypress, California, United States