Performance Evaluation Study for Clearblue Pregnancy Test

September 27, 2011 updated by: SPD Development Company Limited
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Anticipated)

800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342-1524
        • Radiant Research Inc
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Radiant Research, Inc.
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • Radiant Research Inc
    • Texas
      • Dallas, Texas, United States, 75321
        • Radiant Research Inc
      • San Antonio, Texas, United States, 78229
        • Radiant Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Eligibility:

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Investigators

  • Principal Investigator: Phyllis Marx, MD, Radiant Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

February 26, 2010

First Posted (Estimate)

March 1, 2010

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

September 27, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-0148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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