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Pregnancy

Clearblue Pregnancy Test Lay User Usage Study

Sponsored by SPD Development Company Limited

About this trial

Last updated 4 years ago

Study ID

PROTOCOL-1133

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
Female
Female

Trial Timing

Ended 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status