Pregnancy RelatedNCT04372745
Home Pregnancy Test Evaluation, Lay User Study
An observational study of Pregnancy Related, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
This study is a performance evaluation study to assess the performance of a home pregnancy test (HPT) in the hands of lay users by comparing their results, when used according to the Instructions for Use (IFU), to (a) the lay user confirmed pregnancy status, as determined by a CE marked product, and (b) to trained… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related
- How many people
- 129 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Oct 2020to 4 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female volunteers representative of home pregnancy test users.
Who may be able to join
- Willing to give informed consent
- Willing to conduct a personal home pregnancy test and reveal their pregnancy status
- Seeking to conceive, wishing to conduct a pregnancy test or having recently found out they are pregnant
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
- Healthcare professionals (HCP's) with professional experience either using lateral flow-based devices or conducting near patient testing
- If pregnant, known to be beyond the first trimester (defined as last menstrual period, LMP +13 weeks)
- aken a hormonal preparation containing hCG in the last month, e.g. Pregnyl ®
- Has previously taken part in this study
- Seen the product within the past 6 months
- Immediate relatives are defined as parents, children, siblings or partner/spouse
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: Evaluation of Home Pregnancy Test by Lay Users Study
This study is a performance evaluation study to assess the performance of a home pregnancy test (HPT) in the hands of lay users by comparing their results, when used according to the Instructions for Use (IFU), to (a) the lay user confirmed pregnancy status, as determined by a CE marked product, and (b) to trained technicians testing the same urine samples.
The study will also assess the lay user's ability to correctly read results from randomised standards, in addition to leaflet comprehension and product ease of use.
Read the detailed description
This is an observational study, designed to assess the performance of a home pregnancy test.
The study aims to recruit at total 120 volunteers, being approximately equal numbers of 'pregnant' and not-pregnant' women. Volunteers will be recruited either via direct invitation or advertisement and will attend the study site for one visit lasting 30-40 minutes
Written informed consent will be obtained from all volunteers prior to starting the study.
All volunteers will be issues a unique study number on admission to the study. All data and samples collected will be anonymised throughout the study.
Volunteers will be provided with one investigational home pregnancy test and instructions for use. They will be asked to conduct the test, following the product instructions to obtain a test result which will be recorded on the result sheet. Volunteers will be instructed the product is investigational and the results should not be relied upon to determine their pregnancy status.
Study volunteers will then be interviewed by the study technician, with regards to their understanding of the product instructions and complete an ease of use questionnaire. The comprehension interview may be recorded.
The study technician will then perform 2 further investigational home pregnancy tests on randomised urine standards and the volunteer will read the results.
Finally, the study technician will test the volunteer's urine sample with a marketed pregnancy test and record these results on the results sheet. The results of this test will be used to provide the volunteer with her pregnancy status at the end of the study.
Urine samples provided by the volunteers will be tested with the investigational HPT by an independent technician and also measured for hCG by quantitative immunoassay. Samples may also be measured for other hormones related to pregnancy and fertility.
With participant permission, the samples may be retained frozen within the SPD BioBank and used for future product evaluation or research purposes.
- Conditions
- Pregnancy Related
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement with pregnancy status
The accuracy of the investigational HPT will be calculated against the confirmed pregnancy status of the sample. The corresponding 95% confidence interval will also be calculated for the measure.
Measured: 3 months
Secondary outcomes (4)
Agreement with technician results
The agreement between the lay-user and technician results when both testing the same sample with the investigational HPT as per the IFU. The corresponding 95% confidence interval will also be calculated for the measure.
Measured: 3 months
Comprehension of instructions for use
The percentage number of correct answers in the IFU comprehension exercise
Measured: 3 months
Ease of product use
The cumulative Likert scores for ease of use questions on the device usability questionnaire will be calculated, using a 7 point likert scale, where 1 is equivalent to very easy and 7 is equivalent to very difficult.
Measured: 3 months
Ability to read result
The agreement between the lay-user read of a investigational HPT tested with a spiked standard against the expected result of the spiked standard. The corresponding 95% confidence interval will also be calculated.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start8 Oct 2020
- Primary completion4 Nov 2020
- Study completion4 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Principal investigator, SPD Development Company Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372745
- Sponsor's protocol ID
- PROTOCOL-1146
- Status last verified
- Feb 2021
- First submitted
- 21 Apr 2020
- Last updated
- 9 Feb 2021
- 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 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Home Pregnancy Test by Lay Users Study
- ClinicalTrials.gov ID
- NCT04372745
- Acronym / sponsor ID
- PROTOCOL-1146
- Conditions
- Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 4 Nov 2020 (actual)
- Study completion
- 4 Nov 2020 (actual)
- First posted
- 4 May 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 study is a performance evaluation study to assess the performance of a home pregnancy test (HPT) in the hands of lay users by comparing their results, when used according to the Instructions for Use (IFU), to (a) the lay user confirmed pregnancy status, as determined by a CE marked product, and (b) to trained technicians testing the same urine samples.
The study will also assess the lay user's ability to correctly read results from randomised standards, in addition to leaflet comprehension and product ease of use.
Detailed description
This is an observational study, designed to assess the performance of a home pregnancy test.
The study aims to recruit at total 120 volunteers, being approximately equal numbers of 'pregnant' and not-pregnant' women. Volunteers will be recruited either via direct invitation or advertisement and will attend the study site for one visit lasting 30-40 minutes
Written informed consent will be obtained from all volunteers prior to starting the study.
All volunteers will be issues a unique study number on admission to the study. All data and samples collected will be anonymised throughout the study.
Volunteers will be provided with one investigational home pregnancy test and instructions for use. They will be asked to conduct the test, following the product instructions to obtain a test result which will be recorded on the result sheet. Volunteers will be instructed the product is investigational and the results should not be relied upon to determine their pregnancy status.
Study volunteers will then be interviewed by the study technician, with regards to their understanding of the product instructions and complete an ease of use questionnaire. The comprehension interview may be recorded.
The study technician will then perform 2 further investigational home pregnancy tests on randomised urine standards and the volunteer will read the results.
Finally, the study technician will test the volunteer's urine sample with a marketed pregnancy test and record these results on the results sheet. The results of this test will be used to provide the volunteer with her pregnancy status at the end of the study.
Urine samples provided by the volunteers will be tested with the investigational HPT by an independent technician and also measured for hCG by quantitative immunoassay. Samples may also be measured for other hormones related to pregnancy and fertility.
With participant permission, the samples may be retained frozen within the SPD BioBank and used for future product evaluation or research purposes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female volunteers representative of home pregnancy test users.
Key inclusion criteria (3 listed)
- Willing to give informed consent
- Willing to conduct a personal home pregnancy test and reveal their pregnancy status
- Seeking to conceive, wishing to conduct a pregnancy test or having recently found out they are pregnant
Key exclusion criteria (8 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
- Healthcare professionals (HCP's) with professional experience either using lateral flow-based devices or conducting near patient testing
- If pregnant, known to be beyond the first trimester (defined as last menstrual period, LMP +13 weeks)
- aken a hormonal preparation containing hCG in the last month, e.g. Pregnyl ®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement with pregnancy status
Time frame: 3 months
The accuracy of the investigational HPT will be calculated against the confirmed pregnancy status of the sample. The corresponding 95% confidence interval will also be calculated for the measure.
4 secondary outcomes
Agreement with technician results
Time frame: 3 months
Comprehension of instructions for use
Time frame: 3 months
Ease of product use
Time frame: 3 months
Ability to read result
Time frame: 3 months
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 9 Feb 2021.
- 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 principal investigator
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 8 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 9 Feb 2021. 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 pregnancy status (time frame: 3 months). 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 9 Feb 2021.