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Clearblue Home Pregnancy Test Consumer Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01279486
First Posted: January 19, 2011
Last Update Posted: September 28, 2011
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

Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clearblue Home Pregnancy Test Consumer Study

Further study details as provided by SPD Development Company Limited:

Primary Outcome Measures:
  • Consumer agreement [ Time Frame: Completion of laboratory testing ]
    The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results.


Biospecimen Retention:   Samples Without DNA
Urine samples

Estimated Enrollment: 120
Study Start Date: December 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Approximately 120 female volunteers attending the study site requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample to evaluate performance between consumer and technician testing.

  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
Sampling Method:   Non-Probability Sample
Study Population
Volunteers requesting a pregnancy test
Criteria

Inclusion Criteria:

  • 18-45 year old
  • Female
  • Requesting a pregnancy test

Exclusion Criteria:

  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): NCT01279486


Locations
United Kingdom
Bedford General Hospital
Bedford, Bedfordshire, United Kingdom, MK42 9DJ
Brook clinic
Milton Keynes, United Kingdom, MK9 2FX
Sponsors and Collaborators
SPD Development Company Limited
Investigators
Principal Investigator: Kanagaratnam Shanmugaratnam National Health Service, United Kingdom
  More Information

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01279486     History of Changes
Other Study ID Numbers: PROTOCOL-0187
First Submitted: December 24, 2010
First Posted: January 19, 2011
Last Update Posted: September 28, 2011
Last Verified: September 2011

Keywords provided by SPD Development Company Limited:
Pregnancy,