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Consumer in Stream and Container Collected Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01577901
First Posted: April 16, 2012
Last Update Posted: August 15, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
SPD Development Company Limited
  Purpose
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.

Condition Intervention
Determination of Pregnancy Status Other: Clearblue Advanced

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Consumer in Stream and Container Collected Study

Further study details as provided by SPD Development Company Limited:

Primary Outcome Measures:
  • 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.


Enrollment: 168
Study Start Date: March 2012
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Clearblue Advanced
    Pregnancy test
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
United Kingdom
SPD Development Company Ltd.
Bedford, Bedfordshire, United Kingdom, MK44 3UP
Sponsors and Collaborators
SPD Development Company Limited
Investigators
Principal Investigator: Pauline A Parkinson, BSc SPD Development Company Limited
  More Information

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01577901     History of Changes
Other Study ID Numbers: PROTOCOL-0425
First Submitted: April 11, 2012
First Posted: April 16, 2012
Last Update Posted: August 15, 2012
Last Verified: July 2012

Keywords provided by SPD Development Company Limited:
Pregnancy