Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
81 participants
OBSERVATIONAL
2020-11-09
2020-11-11
Brief Summary
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Volunteers recruited into the study and meeting the criteria will test a randomised pregnant or not pregnant urine sample sourced from SPD's biobank with a new home pregnancy test. Volunteers will be required to follow the product instructions for use (IFU).
The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number. An independent study technician not involved in study conduct will be responsible for blinding the samples.
Detailed Description
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Volunteers will be advised that the product they will be testing is under investigation and that the volunteer will not be testing their own urine and therefore volunteers will not learn their own pregnancy status.
Volunteers will be required to consent to the study prior to participation. Each volunteer will test only one device, they will be provided with one investigational device and one urine sample. The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number.
When ready the volunteer will be required to read the IFU prior to testing the urine sample provided with the investigational device according to the instructions. The volunteer will advise the study technician of the result, who will record this on the result sheet.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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home pregnancy test
use of home pregnancy test
Eligibility Criteria
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Inclusion Criteria
* Aged ≥18 years
* Willing to give informed consent
Exclusion Criteria
* Has an immediate relative currently or previously (within last 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G or affiliates
* Is a qualified or trainee Healthcare Professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Has previously taken part in this study
* Seen the product within the past 6 months
18 Years
FEMALE
No
Sponsors
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SPD Development Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Sarah Johnson
Role: STUDY_DIRECTOR
SPD Development Company Ltd
Locations
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SPD Development Company Ltd.
Bedford, Bedfordshire, United Kingdom
Countries
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Other Identifiers
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PROTOCOL-1147
Identifier Type: -
Identifier Source: org_study_id