Clearblue Pregnancy Test Lay User Usage Study | NCT04746014

Studies
Clearblue Pregnancy Test Lay User Usage Study

NCT04746014

Sponsor

SPD Development Company Limited

Status

Completed

Last Update Posted

Aug 6, 2021Actual

Enrollment

306Actual

Phase

Not provided

Conditions

Pregnancy

Interventions

Clearblue Pregnancy Test

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 9, 2021Actual

Primary Completion Date

Aug 3, 2021Actual

Completion Date

Aug 3, 2021Actual

First Submitted Date

Feb 4, 2021

First Submission Date that Met QC Criteria

Feb 4, 2021

First Posted Date

Feb 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2021

Last Update Posted Date

Aug 6, 2021Actual

Name	Class
WCCT Global	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

306Actual

Name	Type	Description	Arm Group Labels	Other Names
Clearblue Pregnancy Test	Diagnostic Test	Urine Pregnancy Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Accuracy of Clearblue Pregnancy Test	Number of pregnancy tests in agreement with pregnancy status	3 days

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Female only

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy pregnant or not pregnant volunteers requiring or wishing to conduct a pregnancy test to determine or confirm pregnancy status.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sarah Johnson, PhD	SPD Development Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
WCCT		Cypress	California	90630	United States