Performance Evaluation Study for Clearblue Pregnancy Test

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.

Completed

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Radiant Research Inc, Atlanta, Georgia, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

The agreement of the Clearblue Pregnancy Test result with Duration of Pregnancy.

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Mar 1, 2010
Registry last updated: Sep 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed