Home Pregnancy Test Evaluation Study

Pregnancy Testing Clinical Trial

Official title:

Home Pregnancy Test Evaluation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589534
• Other study ID #: PROTOCOL-0972
• Status: Completed
• Phase: N/A
• Start date: June 6, 2018
• Est. completion date: August 13, 2018

Study information

• Verified date: July 2018
• Source: SPD Development Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: August 13, 2018
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Testing

Intervention

Diagnostic Test:
• home pregnancy test
Each participant will use 4 different home pregnancy tests

Locations

Country	Name	City	State
United Kingdom	SPD Development Company Ltd.	Bedford	Bedfordshire

Sponsors (1)

Lead Sponsor	Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Demonstration of volunteer preference for a HPTs.	• The cumulative scores on a 7-point likert scale for ease of use questions on the device usability at home questionnaire, where 1 equals very good and 7 equals very poor for each attribute.	1 week
Primary	2. Demonstration of volunteer readability of HPTs	• The cumulative scores on a 7-point likert scale for readability questions on the device readability at SPD questionnaire, where 1 equals very easy and 7 equals very difficult for each attribute.	1 week
Primary	3. Demonstration of consumer preference for a HPT	• The ranking of each Home Pregnancy Test in order of preference	1 week
Secondary	1. Accuracy of reading	The per cent agreement (accuracy) between the result read by the volunteer and true result for each standard tested (i.e 0 hCG will be not pregnant and 25mIU/ml hCG will be pregnant) for each Home pregnancy test evaluated.	1 week
Secondary	Agreement of reading	The agreement between volunteer home pregnancy test results and those of a technician testing the same urine standard (volunteer vs. technician test result)	1 week