Clearblue Pregnancy Test Lay User Usage Study
Completed
Conditions studied: Pregnancy
In brief
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.
Key facts
- Study ID
- NCT04746014
- Run by
- SPD Development Company Limited
- People needed
- 306
- Starts
- 2021-02-09
- Expected to finish
- 2021-08-03
- Last updated by the study team
- 2021-08-06
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- WCCT — Cypress, California, United States
Full record on ClinicalTrials.gov
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