Clearblue Home Pregnancy Test Consumer Study

Completed

• Conditions: Pregnancy

• Registration Number: NCT01279486
• Lead Sponsor: SPD Development Company Limited

Brief Summary

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

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-24
• Study First Submitted QC: 2011-01-17
• Study First Posted: 2011-01-19
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2017-05-15
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-31
• Last Update Submitted: 2018-01-31
• Results First Posted: 2018-11-02
• Last Update Posted: 2018-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consumer Agreement	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.

Trial Locations

Locations (2)

Bedford General Hospital; 🇬🇧 Bedford, Bedfordshire, United Kingdom

Brook clinic; 🇬🇧 Milton Keynes, United Kingdom