Clinical trial NCT04746014: Clearblue Pregnancy Test Lay User Usage Study
Official title: Clearblue Pregnancy Test Lay User Usage Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: Lay User
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
Collaborators: name: WCCT Global
First posted: 2021-02-09
Enrollment: 306
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Accuracy of Clearblue Pregnancy Test
timeFrame: 3 days
Secondary outcomes:
measure: Co-ordinator Agreement
timeFrame: 1 day
measure: Comprehension of Instructions for Use
timeFrame: 1 day
measure: Device Usability
timeFrame: 1 day
Other outcomes:
Locations:
city: Cypress
country: United States
facility: WCCT
state: California
Study officials:
affiliation: SPD Development Company
name: Sarah Johnson, PhD
role: STUDY_DIRECTOR
References: