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Home Pregnancy Test Study on BioBank Samples

NCT04610632 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2020-11-13

No results posted yet for this study

Summary

This is a non-clinical lay user study using stored clinical samples from the SPD BioBank.

Volunteers recruited into the study and meeting the criteria will test a randomised pregnant or not pregnant urine sample sourced from SPD's biobank with a new home pregnancy test. Volunteers will be required to follow the product instructions for use (IFU).

The order of testing will be randomised prior to execution of the protocol, and each urine sample will only be identifiable by a unique reference number. An independent study technician not involved in study conduct will be responsible for blinding the samples.

Conditions

  • Pregnancy Related

Interventions

DIAGNOSTIC_TEST

home pregnancy test

use of home pregnancy test

Sponsors & Collaborators

  • SPD Development Company Limited

    lead INDUSTRY

Principal Investigators

  • Sarah Johnson · SPD Development Company Ltd

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2020-11-11
Completion
2020-11-11

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 NCT04610632 on ClinicalTrials.gov