Clearblue Pregnancy Test Lay User Usage Study

Pregnancy Clinical Trial

Official title:

Clearblue Pregnancy Test Lay User Usage Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746014
• Other study ID #: PROTOCOL-1133
• Status: Completed
• Start date: February 9, 2021
• Est. completion date: August 3, 2021

Study information

• Verified date: August 2021
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: August 3, 2021
• Est. primary completion date: August 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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 tests in agreement with pregnancy status	3 days
Secondary	Co-ordinator Agreement	Number of lay users who record the same pregnancy test result as a trained study co-ordinator	1 day
Secondary	Comprehension of Instructions for Use	Number of volunteers who answer each comprehension question correctly	1 day
Secondary	Device Usability	Number of volunteers who record the device as easy to use	1 day