Status:
COMPLETED
Clearblue Pregnancy Test Lay User Usage Study
Lead Sponsor:
SPD Development Company Limited
Collaborating Sponsors:
WCCT Global
Conditions:
Pregnancy
Eligibility:
FEMALE
18+ years
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 ...
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 performanc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 9 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 3 2021
Estimated Enrollment :
306 Patients enrolled
Trial Details
Trial ID
NCT04746014
Start Date
February 9 2021
End Date
August 3 2021
Last Update
August 6 2021
Active Locations (1)
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1
WCCT
Cypress, California, United States, 90630