Clinical trial NCT03589534: Home Pregnancy Test Evaluation Study
Official title: Home Pregnancy Test Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Testing
Lead sponsor: SPD Development Company Limited
Sponsor class: INDUSTRY
First posted: 2018-07-18
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: 1. Demonstration of volunteer preference for a HPTs.
timeFrame: 1 week
measure: 2. Demonstration of volunteer readability of HPTs
timeFrame: 1 week
measure: 3. Demonstration of consumer preference for a HPT
timeFrame: 1 week
Secondary outcomes:
measure: 1. Accuracy of reading
timeFrame: 1 week
measure: Agreement of reading
timeFrame: 1 week
Other outcomes:
Locations:
city: Bedford
country: United Kingdom
facility: SPD Development Company Ltd.
state: Bedfordshire
Study officials:
References:
citation: Boxer J, Weddell S, Broomhead D, Hogg C, Johnson S. Home pregnancy tests in the hands of the intended user. J Immunoassay Immunochem. 2019;40(6):642-652. doi: 10.1080/15321819.2019.1671861. Epub 2019 Sep 26.