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
NA
943 participants
INTERVENTIONAL
2015-07-31
2015-12-31
Brief Summary
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Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.
Detailed Description
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The technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a Clearblue Digital HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.
At the end of the study visit, all volunteers will be provided with materials to allow follow-up for the determination of pregnancy status.
The majority of volunteers will be requested to provide one additional urine sample, collected 2 days after the study visit. If early pregnancy is suspected the volunteer will be requested to provide an additional 7 daily urine samples following the study visit. All volunteers will be required to provide details of pregnancy status (documented menses or pregnancy confirmation by health care professional) after the study visit.
True pregnancy status will be determined by laboratory tests and clinical information. The study will continue until a minimum of 300 pregnant and 300 not pregnant volunteers have completed the study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Pregnancy test
Clearblue investigational Pregnancy test
Clearblue Marketed pregnancy test
Professional pregnancy test
Clearblue Investigational Pregnancy test
Clearblue Investigational Pregnancy test
Professional pregnancy test
Alere Professional use pregnancy test
Clearblue Marketed Pregnancy test
Clearblue Marketed Pregnancy test
Interventions
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Clearblue Investigational Pregnancy test
Clearblue Investigational Pregnancy test
Professional pregnancy test
Alere Professional use pregnancy test
Clearblue Marketed Pregnancy test
Clearblue Marketed Pregnancy test
Eligibility Criteria
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Inclusion Criteria
* Aged 18 or over
* Willing to conduct a personal pregnancy test and reveal their pregnancy status
* Willing to give informed consent
Exclusion Criteria
* Has an immediate relative\* currently or previously employed by SPD, Alere, Unipath or P\&G or affiliates
* Previously used the investigational HPT within the last six months
* Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing
* Confirmed to be pregnant by a healthcare professional and beyond the first trimester
* Taken a hormonal preparation containing human chorionic gonadotropin (hCG) in the last month, e.g. Pregnyl®
18 Years
FEMALE
Yes
Sponsors
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Illingworth Research Ltd
UNKNOWN
SPD Development Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Juliet Hulse
Role: PRINCIPAL_INVESTIGATOR
Illingworth Research Ltd
Locations
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Illingworth Research Ltd
Macclesfield, Chester, United Kingdom
Countries
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Other Identifiers
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PROTOCOL-0772
Identifier Type: -
Identifier Source: org_study_id