Home Pregnancy Test Study on BioBank Samples

November 11, 2020 updated by: SPD Development Company Limited

Home Pregnancy Test Study Lay User 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Bedfordshire
      • Bedford, Bedfordshire, United Kingdom, MK44 3UP
        • SPD Development company Ltd.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

General public

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPD Development Company Limited

Investigators

  • Study Director: Sarah Johnson, SPD Development Company Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 9, 2020

Primary Completion (ACTUAL)

November 11, 2020

Study Completion (ACTUAL)

November 11, 2020

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 11, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • PROTOCOL-1147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe