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Performance Evaluation Study for Clearblue Pregnancy Test

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.
 
ClinicalTrials.gov Identifier: NCT01077583
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : September 28, 2011
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited

Study Description
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Brief Summary:
The purpose of this study is to collect urine samples and dating scan information from women who wish to become pregnant. Urine samples will be tested in the laboratory with the Clearblue Pregnancy Test and the results correlated with volunteer information.

Condition or disease
Pregnancy

Detailed Description:

Approximately 800 female volunteers wishing to become pregnant will be recruited locally around 5 trial centers within the US.

Daily urine samples and gestational age dating scan information obtained from the study will be used in laboratory tests to assess the accuracy of the Clearblue Pregnancy Test. Product assessment will involve testing of early morning urine samples collected by women during the cycle in which they conceived. Urine samples will be collected pre-conception to the end of the second trimester.

Study Design
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Study Type : Observational
Estimated Enrollment : 800 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Performance Evaluation Study for Clearblue Pregnancy Test
Study Start Date : January 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy. [ Time Frame: 1 year ]

Biospecimen Retention:   Samples Without DNA
Daily early morning urine samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Eligibility:

Ages Eligible for study: 18 - 45 years. Gender Eligible for study Female. Healthy Volunteers Yes.

Criteria

Inclusion Criteria:

  • Provide written informed consent to participate in the study and agree to comply with study procedures.
  • Has menstrual bleeds.
  • Seeking to become pregnant.
  • Intend to seek medical care during pregnancy.

Exclusion Criteria:

  • Has positive pregnancy test on screening.
  • Has received medical treatment for infertility or is participating in an assisted fertility program.
  • Known condition to contra-indicate pregnancy.
Contacts and Locations
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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): NCT01077583


Locations
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United States, Georgia
Radiant Research Inc
Atlanta, Georgia, United States, 30342-1524
United States, Illinois
Radiant Research, Inc.
Chicago, Illinois, United States, 60654
United States, Minnesota
Radiant Research Inc
Edina, Minnesota, United States, 55435
United States, Texas
Radiant Research Inc
Dallas, Texas, United States, 75321
Radiant Research Inc
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
SPD Development Company Limited
Investigators
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Principal Investigator: Phyllis Marx, MD Radiant Research
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01077583    
Other Study ID Numbers: PROTOCOL-0148
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: September 28, 2011
Last Verified: January 2011
Keywords provided by SPD Development Company Limited:
Pregnancy test
Wishing to become pregnant