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NCT01077583 Clinical Trial

Performance Evaluation Study for Clearblue Pregnancy Test

Pregnancy Clinical Trial

Official title:
Performance Evaluation Study for Clearblue Pregnancy Test

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01077583
Other study ID # PROTOCOL-0148
Secondary ID
Status Completed
Phase N/A
First received February 26, 2010
Last updated September 27, 2011
Start date January 2010
Est. completion date July 2011

Study information
Verified date January 2011
Source SPD Development Company Limited
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 800
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Radiant Research Inc Atlanta Georgia
United States Radiant Research, Inc. Chicago Illinois
United States Radiant Research Inc Dallas Texas
United States Radiant Research Inc Edina Minnesota
United States Radiant Research Inc San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
SPD Development Company Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy. 1 year No
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