Home Pregnancy Test Evaluation Study

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Testing
• Intervention / Treatment: Diagnostic test: home pregnancy test

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

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bedfordshire
    • Bedford, Bedfordshire, United Kingdom, MK44 3UP
      • SPD Development company Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: pregnancy test; pregnancy tests	Diagnostic test: home pregnancy test; Each participant will use 4 different home pregnancy tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
3. Demonstration of consumer preference for a HPT	• The ranking of each Home Pregnancy Test in order of preference	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: SPD Development Company Limited

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): August 13, 2018
• Study Completion (Actual): August 13, 2018

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: July 4, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): November 9, 2018
• Last Update Submitted That Met QC Criteria: November 8, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: PROTOCOL-0972

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No