Status:
COMPLETED
Home Pregnancy Test Evaluation, Lay User Study
Lead Sponsor:
SPD Development Company Limited
Conditions:
Pregnancy Related
Eligibility:
FEMALE
18-45 years
Brief Summary
This study is a performance evaluation study to assess the performance of a home pregnancy test (HPT) in the hands of lay users by comparing their results, when used according to the Instructions for ...
Detailed Description
This is an observational study, designed to assess the performance of a home pregnancy test. The study aims to recruit at total 120 volunteers, being approximately equal numbers of 'pregnant' and not...
Eligibility Criteria
Inclusion
- Willing to give informed consent
- Willing to conduct a personal home pregnancy test and reveal their pregnancy status
- Seeking to conceive, wishing to conduct a pregnancy test or having recently found out they are pregnant
Exclusion
- Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
- Has an immediate relative currently or previously (within last 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
- Healthcare professionals (HCP's) with professional experience either using lateral flow-based devices or conducting near patient testing
- If pregnant, known to be beyond the first trimester (defined as last menstrual period, LMP +13 weeks)
- aken a hormonal preparation containing hCG in the last month, e.g. Pregnyl ®
- Has previously taken part in this study
- Seen the product within the past 6 months
- Immediate relatives are defined as parents, children, siblings or partner/spouse
Key Trial Info
Start Date :
October 8 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 4 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT04372745
Start Date
October 8 2020
End Date
November 4 2020
Last Update
February 9 2021
Active Locations (1)
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1
SPD Development Company Ltd
Bedford, Bedfordshire, United Kingdom, MK44 3UP