Clearblue Pregnancy Test Lay User Usage Study

August 5, 2021 updated by: SPD Development Company Limited
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

306

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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 to determine or confirm pregnancy status.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 3 days
Number of pregnancy tests in agreement with pregnancy status
3 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Collaborators

WCCT Global

Investigators

  • Study Director: Sarah Johnson, PhD, SPD Development Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2021

Primary Completion (Actual)

August 3, 2021

Study Completion (Actual)

August 3, 2021

Study Registration Dates

First Submitted

February 4, 2021

First Submitted That Met QC Criteria

February 4, 2021

First Posted (Actual)

February 9, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-1133

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pregnancy

Clinical Trials on Clearblue Pregnancy Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe