Home Pregnancy Test Study on BioBank Samples

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.

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Key information

Conditions

Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

SPD Development Company Ltd.

Bedford, Bedfordshire, MK44 3UP, United Kingdom

About this study

Women will be informed of the opportunity to participate in a study in which they will be required to use a home pregnancy test to test a urine sample provided to them. Interested applicants will be invited to join the study.

Volunteers will be advised that the product they will be testing is under investigation and that the volunteer will not be testing their own urine and therefore volunteers will not learn their own pregnancy status.

Volunteers will be required to consent to the study prior to participation. Each volunteer will test only one device, they will be provided with one investigational device and one urine sample. 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.

When ready the volunteer will be required to read the IFU prior to testing the urine sample provided with the investigational device according to the instructions. The volunteer will advise the study technician of the result, who will record this on the result sheet.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Female
Aged ≥18 years
Willing to give informed consent

Exclusion criteria

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
Is a qualified or trainee Healthcare Professional (HCP)
Has professional experience of using dipstick type tests or lateral flow devices
Has previously taken part in this study
Seen the product within the past 6 months

Treatment and study plan

home pregnancy test

Diagnostic Test

use of home pregnancy test

Primary outcomes

Agreement with confirmed pregnancy result

Time frame: 1 week

The percentage agreement between the result obtained when a lay user test a urine sample, and the confirmed pregnancy status of the volunteer providing the sample. Both confirmed positive (pregnant) and negative (not pregnant) samples will be included in the study.

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Registry information

Official study title

Home Pregnancy Test Study Lay User Study on BioBank Samples

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Oct 30, 2020
Registry last updated: Nov 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed