Clearblue Home Pregnancy Test Consumer Study

NCT ID: NCT01279486

Last Updated: 2018-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 18-45 year old
* Female
* Requesting a pregnancy test
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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SPD Development Company Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kanagaratnam Shanmugaratnam

Role: PRINCIPAL_INVESTIGATOR

National Health Service, United Kingdom

Locations

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Bedford General Hospital

Bedford, Bedfordshire, United Kingdom

Site Status

Brook clinic

Milton Keynes, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PROTOCOL-0187

Identifier Type: -

Identifier Source: org_study_id

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