Clearblue Pregnancy Test - Lay User Study

Completed

Conditions studied: Pregnancy

In brief

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 the performance of a HPT in the hands of lay-users 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

NCT04043169

Run by

SPD Development Company Limited

People needed

204

Starts

2019-07-30

Expected to finish

2019-12-31

Last updated by the study team

2020-02-20

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• WCCT — Cypress, California, United States

Full record on ClinicalTrials.gov

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