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Trial record 15 of 83885 for:    testing

Home Pregnancy Test Evaluation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03589534
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited

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.


Condition or disease Intervention/treatment Phase
Pregnancy Testing Diagnostic Test: home pregnancy test Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Home Pregnancy Test Evaluation Study
Actual Study Start Date : June 6, 2018
Actual Primary Completion Date : August 13, 2018
Actual Study Completion Date : August 13, 2018

Arm Intervention/treatment
pregnancy test
pregnancy tests
Diagnostic Test: home pregnancy test
Each participant will use 4 different home pregnancy tests




Primary Outcome Measures :
  1. 1. Demonstration of volunteer preference for a HPTs. [ Time Frame: 1 week ]
    • 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.

  2. 2. Demonstration of volunteer readability of HPTs [ Time Frame: 1 week ]
    • 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.

  3. 3. Demonstration of consumer preference for a HPT [ Time Frame: 1 week ]
    • The ranking of each Home Pregnancy Test in order of preference


Secondary Outcome Measures :
  1. 1. Accuracy of reading [ Time Frame: 1 week ]
    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.

  2. Agreement of reading [ Time Frame: 1 week ]
    The agreement between volunteer home pregnancy test results and those of a technician testing the same urine standard (volunteer vs. technician test result)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03589534


Locations
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United Kingdom
SPD Development Company Ltd.
Bedford, Bedfordshire, United Kingdom, MK44 3UP
Sponsors and Collaborators
SPD Development Company Limited

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Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT03589534     History of Changes
Other Study ID Numbers: PROTOCOL-0972
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No