Consumer in Stream and Container Collected Study

August 14, 2012 updated by: SPD Development Company Limited
Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue Advanced Pregnancy test, following the instructions for use. The test will be conducted following both the instructions for the in stream method of sampling and the method of testing when a sample is collected into a container. The results will be compared to those achieved by the study technician.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will compare the performance of the Clearblue Advanced Pregnancy Test, when used by consumers according to the instructions for use leaflet (IFUL), and by trained coordinators. Consumer testing will include both sampling in the urine stream and the testing method for urine collected into a container.

In addition, the performance of the Clearblue Advanced Pregnancy Test will be compared to that of the currently marketed Clearblue Digital Pregnancy Test for the detection of pregnancy. In this comparison, both tests will be performed by a trained coordinator using the testing method for urine collected into a container on each volunteer's urine sample.

The study will involve the recruitment of a cross-section of the target pregnancy test users in the United Kingdom, that is, women aged 18-45 who are seeking a pregnancy test. The study will aim to recruit at least 100 volunteers, a minimum of 30 (30%) of whom will be pregnant.

Volunteers will use the Clearblue Advanced Pregnancy Test device using the urine stream method of sampling according to the product instructions. In addition volunteers will be asked to collect a urine sample from the same void and conduct a second Clearblue Advanced Pregnancy Test, using the testing method for urine collected in a container. The volunteer will then complete a study questionnaire on ease of use and leaflet comprehension. The questionnaire, urine sample and used devices will be retained by SPD for evaluation Agreement between the volunteer Pregnancy Test result and study coordinator Pregnancy Test result will be reported.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

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 Kingdom
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK44 3UP
        • SPD Development company Ltd.

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

Description

Inclusion Criteria:

  • Requiring a pregnancy test
  • Willing to provide informed consent and reveal pregnancy status

Exclusion Criteria:

  • Employees of SPD. Unipath, Alere or P&G Previous participation in study Previously used Clearblue Advanced Pregnancy Test.

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of pregnant volunteers as determined by volunteer test result.
Time Frame: 3 months
Comparison of the performance of the Clearblue Advanced Pregnancy Test in consumer hands when tested using the in-stream method of testing with the performance of the device when used by a study coordinator when testing the same urine sample using the method for urine collected into a container.
3 months

Collaborators and Investigators

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

Sponsor

SPD Development Company Limited

Investigators

  • Principal Investigator: Pauline A Parkinson, BSc, SPD Development Company Limited

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

March 1, 2012

Primary Completion (ACTUAL)

July 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

April 11, 2012

First Submitted That Met QC Criteria

April 12, 2012

First Posted (ESTIMATE)

April 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-0425

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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