Consumer in Stream and Container Collected Study
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|ClinicalTrials.gov Identifier: NCT01577901|
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : August 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Determination of Pregnancy Status||Other: Clearblue Advanced||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||168 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Consumer in Stream and Container Collected Study|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2012|
Other: Clearblue Advanced
- number of pregnant volunteers as determined by volunteer test result. [ Time Frame: 3 months ]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.
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): NCT01577901
|SPD Development Company Ltd.|
|Bedford, Bedfordshire, United Kingdom, MK44 3UP|
|Principal Investigator:||Pauline A Parkinson, BSc||SPD Development Company Limited|