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Clearblue Home Pregnancy Test Consumer Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited
ClinicalTrials.gov Identifier:
NCT01279486
First received: December 24, 2010
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by SPD Development Company Limited:

Primary Outcome Measures:
  • Consumer agreement [ Time Frame: Completion of laboratory testing ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01279486     History of Changes
Other Study ID Numbers: PROTOCOL-0187
Study First Received: December 24, 2010
Last Updated: September 27, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by SPD Development Company Limited:
Pregnancy,

ClinicalTrials.gov processed this record on May 16, 2013