Clearblue Home Pregnancy Test Consumer Study

January 31, 2018 updated by: SPD Development Company Limited

Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample.

Study Overview

Status

Completed

Conditions

Detailed Description

Approximately 120 female volunteers attending the study site requesting a pregnancy test will be recruited locally to the UK trial centre.

Volunteers will be required to use the Clearblue Pregnancy Test according to the product instructions, and provide a urine sample from the same void.

Trained technicians will conduct a second test from the urine sample to evaluate performance between consumer and technician testing.

Study Type

Observational

Enrollment (Actual)

120

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
      • Milton Keynes, United Kingdom, MK9 2FX
        • Brook clinic
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK42 9DJ
        • Bedford General Hospital

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

Non-Probability Sample

Study Population

Volunteers requesting a pregnancy test

Description

Inclusion Criteria:

  • 18-45 year old
  • Female
  • Requesting a pregnancy test

Exclusion Criteria:

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
Measure Description
Time Frame
Consumer Agreement
Time Frame: During testing approximately 15 minutes
The agreement of the consumer Clearblue Pregnancy Test result with technician Clearblue Pregnancy Test results when testing the same sample.
During testing approximately 15 minutes

Collaborators and Investigators

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

Sponsor

SPD Development Company Limited

Investigators

  • Principal Investigator: Kanagaratnam Shanmugaratnam, National Health Service, United Kingdom

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

December 1, 2010

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

December 24, 2010

First Submitted That Met QC Criteria

January 17, 2011

First Posted (ESTIMATE)

January 19, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 2, 2018

Last Update Submitted That Met QC Criteria

January 31, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PROTOCOL-0187

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Overview will be available after study is completed

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.

Clinical Trials on Pregnancy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe