Consumer in Stream and Container Collected Study

Study Overview
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Brief Summary
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Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue Advanced Pregnancy test, following the instructions for use. The test will be conducted following both the instructions for the in stream method of sampling and the method of testing when a sample is collected into a container. The results will be compared to those achieved by the study technician.

Detailed Description
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The study will compare the performance of the Clearblue Advanced Pregnancy Test, when used by consumers according to the instructions for use leaflet (IFUL), and by trained coordinators. Consumer testing will include both sampling in the urine stream and the testing method for urine collected into a container. In addition, the performance of the Clearblue Advanced Pregnancy Test will be compared to that of the currently marketed Clearblue Digital Pregnancy Test for the detection of pregnancy. In this comparison, both tests will be performed by a trained coordinator using the testing method for urine collected into a container on each volunteer's urine sample. The study will involve the recruitment of a cross-section of the target pregnancy test users in the United Kingdom, that is, women aged 18-45 who are seeking a pregnancy test. The study will aim to recruit at least 100 volunteers, a minimum of 30 (30%) of whom will be pregnant. Volunteers will use the Clearblue Advanced Pregnancy Test device using the urine stream method of sampling according to the product instructions. In addition volunteers will be asked to collect a urine sample from the same void and conduct a second Clearblue Advanced Pregnancy Test, using the testing method for urine collected in a container. The volunteer will then complete a study questionnaire on ease of use and leaflet comprehension. The questionnaire, urine sample and used devices will be retained by SPD for evaluation Agreement between the volunteer Pregnancy Test result and study coordinator Pregnancy Test result will be reported.

Official Title
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Consumer in Stream and Container Collected Study

Conditions
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Determination of Pregnancy Status

Intervention / Treatment
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* Other: Clearblue Advanced


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Requiring a pregnancy test Willing to provide informed consent and reveal pregnancy status Exclusion Criteria: Employees of SPD. Unipath, Alere or P&G Previous participation in study Previously used Clearblue Advanced Pregnancy Test.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Clearblue Advanced|Pregnancy test|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of pregnant volunteers as determined by volunteer test result. | Comparison of the performance of the Clearblue Advanced Pregnancy Test in consumer hands when tested using the in-stream method of testing with the performance of the device when used by a study coordinator when testing the same urine sample using the method for urine collected into a container. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy