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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: October 12, 2017
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
December 24, 2010
January 19, 2011
October 12, 2017
December 2010
June 2011   (Final data collection date for primary outcome measure)
Consumer agreement [ Time Frame: Completion of laboratory testing ]
The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results.
Same as current
Complete list of historical versions of study NCT01279486 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Clearblue Home Pregnancy Test Consumer Study
Clearblue Home Pregnancy Test Consumer Study

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
Urine samples
Non-Probability Sample
Volunteers requesting a pregnancy test
Pregnancy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

Sexes Eligible for Study: Female
18 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01279486
PROTOCOL-0187
No
Not Provided
Not Provided
SPD Development Company Limited
SPD Development Company Limited
Not Provided
Principal Investigator: Kanagaratnam Shanmugaratnam National Health Service, United Kingdom
SPD Development Company Limited
September 2011