Consumer in Stream and Container Collected Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Determination of Pregnancy Status

Keywords

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Pregnancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Clearblue Advanced

Pregnancy test

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pauline A Parkinson, BSc

Role: PRINCIPAL_INVESTIGATOR

SPD Development Company Limited

Locations

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SPD Development Company Ltd.

Bedford, Bedfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PROTOCOL-0425

Identifier Type: -

Identifier Source: org_study_id