Home Pregnancy Test Evaluation, Lay User Study

NCT04372745 | Completed

• 1 other identifier: PROTOCOL-1146
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Agreement with pregnancy status

  The accuracy of the investigational HPT will be calculated against the confirmed pregnancy status of the sample. The corresponding 95% confidence interval will also be calculated for the measure.

  3 months

Secondary Outcomes (4)

• Agreement with technician results

  3 months

• Comprehension of instructions for use

  3 months

• Ease of product use

  3 months

• Ability to read result

  3 months

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female volunteers representative of home pregnancy test users.

You may qualify if:

• Willing to give informed consent
• Willing to conduct a personal home pregnancy test and reveal their pregnancy status
• Seeking to conceive, wishing to conduct a pregnancy test or having recently found out they are pregnant

You may not qualify if:

• Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
• Has an immediate relative currently or previously (within last 5 years) employed by SPD, Abbott, Alere, Unipath or P\&G, or affiliates
• Healthcare professionals (HCP's) with professional experience either using lateral flow-based devices or conducting near patient testing
• If pregnant, known to be beyond the first trimester (defined as last menstrual period, LMP +13 weeks)
• aken a hormonal preparation containing hCG in the last month, e.g. Pregnyl ®
• Has previously taken part in this study
• Seen the product within the past 6 months
• Immediate relatives are defined as parents, children, siblings or partner/spouse

Sponsors & Collaborators

• SPD Development Company Limited: lead

Study Sites (1)

SPD Development Company Ltd

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine sample

Study Officials

• Sarah Johnson

  SPD Development Company Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: May 4, 2020
• Study Start: October 8, 2020
• Primary Completion: November 4, 2020
• Study Completion: November 4, 2020
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)