Clearblue Pregnancy Test - Lay User Study

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Diagnostic test: Clearblue pregnancy test

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.

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • WCCT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Healthy pregnant, or not pregnant volunteers requiring or wishing to conduct a pregnancy test.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Clearblue pregnancy test	Number of pregnancy test results in agreement with clinical pregnancy status	3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sample method agreement	number of volunteers who record the same pregnancy test result using the 'in stream' and 'dip' method of sampling	1 day
Coordinator agreement	number of volunteers who record the same pregnancy test result as a trained study coordinator	1 day
Device usability	number of volunteers who record the device as easy to use	1 day

Collaborators and Investigators

• Sponsor: SPD Development Company Limited
• Collaborators: WCCT Global

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2019
• Primary Completion (Actual): November 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 1, 2019
• First Submitted That Met QC Criteria: August 1, 2019
• First Posted (Actual): August 2, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-0971

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No