Performance Evaluation Study for Clearblue Pregnancy Test

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
SPD Development Company Limited
ClinicalTrials.gov Identifier:
NCT01077583
First received: February 26, 2010
Last updated: September 27, 2011
Last verified: January 2011
  Purpose

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
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Performance Evaluation Study for Clearblue Pregnancy Test

Further study details as provided by SPD Development Company Limited:

Primary Outcome Measures:
  • The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Daily early morning urine samples


Estimated Enrollment: 800
Study Start Date: January 2010
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077583

Locations
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
Principal Investigator: Phyllis Marx, MD Radiant Research
  More Information

No publications provided

Responsible Party: SPD Development Company Limited
ClinicalTrials.gov Identifier: NCT01077583     History of Changes
Other Study ID Numbers: PROTOCOL-0148
Study First Received: February 26, 2010
Last Updated: September 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by SPD Development Company Limited:
Pregnancy test
Wishing to become pregnant

ClinicalTrials.gov processed this record on October 20, 2014