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Clearblue Pregnancy Test - Lay User Study

NCT04043169 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 204

Last updated 2020-02-20

No results posted yet for this study

Summary

The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.

Conditions

  • Pregnancy

Interventions

DIAGNOSTIC_TEST

Clearblue pregnancy test

Urine pregnancy test

Sponsors & Collaborators

  • WCCT Global

    collaborator INDUSTRY

  • SPD Development Company Limited

    lead INDUSTRY

Principal Investigators

  • Sarah Johnson · SPD Development company Ltd.

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-30
Primary Completion
2019-11-30
Completion
2019-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04043169 on ClinicalTrials.gov