Home Pregnancy Test Evaluation Study

Swiss Precision Diagnostics (SPD)

Status

Completed

Conditions

Pregnancy Testing

Treatments

Diagnostic Test: home pregnancy test

Study type

Interventional

Funder types

Industry

Identifiers

NCT03589534

PROTOCOL-0972

Details and patient eligibility

About

This study will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests.

The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe.

Full description

The study will be conducted in two parts:

Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different tests being evaluated) in their own home to gain usability data. All products will be used according to their instructions for use which, where required, will be translated into English prior to the study start. A study questionnaire will be completed after each test is used.

Part 2: The volunteers will attend the study site soon after completing their last home test and be required to read randomised results of tests conducted by study technicians (pregnant and not pregnant) to gain an understanding of their ability to correctly read results of the tests. The technician will also read and record the test results to enable both the laboratory agreement (technician read) and the consumer readability to be determined and compared for each product.

Each volunteer will be required to provide a urine sample for determining pregnancy status and quantitative urinary hormone measurement (this is done to confirm the result obtained at home using the HPTs).

At the end of the testing period the volunteers will also be asked to rank the four products they have used in the study, based on a series of statements regarding usability and readability of the tests

Enrollment

250 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Female
Aged 18-45 years
Willing to give informed consent
Willing to conduct a personal home pregnancy test and reveal their pregnancy status

Exclusion criteria

Currently or previously employed by SPD, Alere, Unipath, P&G, Abbott, or affiliates
Has an immediate relative* currently or previously employed by SPD, Alere, Unipath, P&G, Abbott or affiliates
Taken a hormonal preparation containing hCG in the last month, e.g. Pregnyl®
Recently miscarried and yet to have 2 complete menstrual cycles before study start