Status:
COMPLETED
Clearblue Pregnancy Test - Lay User Study
Lead Sponsor:
SPD Development Company Limited
Collaborating Sponsors:
WCCT Global
Conditions:
Pregnancy
Eligibility:
FEMALE
18-45 years
Brief Summary
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...
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 day...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 30 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04043169
Start Date
July 30 2019
End Date
December 31 2019
Last Update
February 20 2020
Active Locations (1)
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1
WCCT
Cypress, California, United States, 90630