NCT04610632

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2 days

First QC Date

October 27, 2020

Last Update Submit

November 11, 2020

Conditions

Pregnancy Related

Outcome Measures

Primary Outcomes (1)

  • Agreement with confirmed pregnancy result

    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

Interventions

home pregnancy testDIAGNOSTIC_TEST

use of home pregnancy test

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

General public

You may qualify if:

  • Female
  • Aged ≥18 years
  • Willing to give informed consent

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SPD Development Company Ltd.

Bedford, Bedfordshire, MK44 3UP, United Kingdom

Location

Study Officials

  • Sarah Johnson

    SPD Development Company Ltd

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 27, 2020

First Posted

October 30, 2020

Study Start

November 9, 2020

Primary Completion

November 11, 2020

Study Completion

November 11, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)