Clearblue Pregnancy Test - Lay User Study

Pregnancy Clinical Trial

Official title:

Clearblue Pregnancy Test - Lay User Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04043169
• Other study ID #: PROTOCOL-0971
• Status: Completed
• Start date: July 30, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: December 31, 2019
• Est. primary completion date: November 30, 2019
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Female

• Aged 18 to 45

• Willing to conduct a 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

• Has professional experience of using lateral flow-based devices

• Beyond the first trimester of pregnancy

• Taken a hormonal preparation containing hCG in the last month.

• Has a medical condition that means that it is not appropriate to give a blood.

Related Conditions & MeSH terms

• Pregnancy

Intervention

Diagnostic Test:
• Clearblue pregnancy test
Urine pregnancy test

Locations

Country	Name	City	State
United States	WCCT	Cypress	California

Sponsors (2)

Lead Sponsor	Collaborator
SPD Development Company Limited	WCCT Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Clearblue pregnancy test	Number of pregnancy test results in agreement with clinical pregnancy status	3 days
Secondary	Sample method agreement	number of volunteers who record the same pregnancy test result using the 'in stream' and 'dip' method of sampling	1 day
Secondary	Coordinator agreement	number of volunteers who record the same pregnancy test result as a trained study coordinator	1 day
Secondary	Device usability	number of volunteers who record the device as easy to use	1 day