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Clearblue Pregnancy Test Lay User Usage Study

NCT04746014 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 306

Last updated 2021-08-06

No results posted yet for this study

Summary

The Clearblue home pregnancy test (HPT) is an over the counter urine hCG (human chorionic gonadotrophin) visual pregnancy test which is intended for the detection of pregnancy. This study will assess the performance of the HPT in the hands of the lay user 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, PhD · SPD Development Company

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-09
Primary Completion
2021-08-03
Completion
2021-08-03
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 NCT04746014 on ClinicalTrials.gov