Pregnancy RelatedNCT04610632
Home Pregnancy Test Study on BioBank Samples
An observational study of Pregnancy Related, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related
- What is being tested?
- home pregnancy test
- How many people
- 81 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Nov 2020to 11 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: General public
Who may be able to join
- Female
- Aged ≥18 years
- Willing to give informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd.
Bedford, Bedfordshire, MK44 3UP
About this study
Official title: 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.
Read the 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.
- Conditions
- Pregnancy Related
- Being tested
- home pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home pregnancy testDiagnostic test
use of home pregnancy test
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start9 Nov 2020
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, SPD Development Company Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610632
- Sponsor's protocol ID
- PROTOCOL-1147
- Status last verified
- Nov 2020
- First submitted
- 27 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Pregnancy Test Study Lay User Study on BioBank Samples
- ClinicalTrials.gov ID
- NCT04610632
- Acronym / sponsor ID
- PROTOCOL-1147
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- General public
Key inclusion criteria (3 listed)
- Female
- Aged ≥18 years
- Willing to give informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home pregnancy testuse of home pregnancy test | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Johnson study director
SPD Development Company Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related, run by SPD Development Company Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement with confirmed pregnancy result (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.