Home Pregnancy Test Study on BioBank Samples

Completed

• Conditions: Pregnancy Related

• Registration Number: NCT04610632
• Lead Sponsor: SPD Development Company Limited

Brief 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.

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 Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Status Verified: 2020-11
• Study Start: 2020-11-09
• Primary Completion: 2020-11-11
• Study Completion: 2020-11-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Agreement with confirmed pregnancy result	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.

Trial Locations

Locations (1)

SPD Development Company Ltd.; 🇬🇧 Bedford, Bedfordshire, United Kingdom