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Home Pregnancy Test Evaluation, Lay User Study

NCT04372745 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 129

Last updated 2021-02-09

No results posted yet for this study

Summary

This study is a performance evaluation study to assess the performance of a home pregnancy test (HPT) in the hands of lay users by comparing their results, when used according to the Instructions for Use (IFU), to (a) the lay user confirmed pregnancy status, as determined by a CE marked product, and (b) to trained technicians testing the same urine samples.

The study will also assess the lay user's ability to correctly read results from randomised standards, in addition to leaflet comprehension and product ease of use.

Conditions

  • Pregnancy Related

Sponsors & Collaborators

  • 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
Yes

Timeline & Regulatory

Start
2020-10-08
Primary Completion
2020-11-04
Completion
2020-11-04

Countries

  • United Kingdom

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 NCT04372745 on ClinicalTrials.gov