Pregnancy TestingNCT03589534
Home Pregnancy Test Evaluation Study
A study testing home pregnancy test in people with Pregnancy Testing, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
This study will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests. The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe. 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 Testing
- What is being tested?
- home pregnancy test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2018to 13 Aug 2018
- Phase
- Interventional
- 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
Who may be able to join
- Female
- Aged 18-45 years
- Willing to give informed consent
- Willing to conduct a personal home pregnancy test and reveal their pregnancy status
Who cannot join
- Currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott, or affiliates
- Has an immediate relative* currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott or affiliates
- Taken a hormonal preparation containing hCG in the last month, e.g. Pregnyl®
- Recently miscarried and yet to have 2 complete menstrual cycles before study start
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
SPD Development Company Ltd.
Bedford, Bedfordshire, MK44 3UP
About this study
This study will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests.
The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe.
Read the detailed description
The study will be conducted in two parts:
Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different tests being evaluated) in their own home to gain usability data. All products will be used according to their instructions for use which, where required, will be translated into English prior to the study start. A study questionnaire will be completed after each test is used.
Part 2: The volunteers will attend the study site soon after completing their last home test and be required to read randomised results of tests conducted by study technicians (pregnant and not pregnant) to gain an understanding of their ability to correctly read results of the tests. The technician will also read and record the test results to enable both the laboratory agreement (technician read) and the consumer readability to be determined and compared for each product.
Each volunteer will be required to provide a urine sample for determining pregnancy status and quantitative urinary hormone measurement (this is done to confirm the result obtained at home using the HPTs).
At the end of the testing period the volunteers will also be asked to rank the four products they have used in the study, based on a series of statements regarding usability and readability of the tests
- Conditions
- Pregnancy Testing
- 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
Each participant will use 4 different home pregnancy tests
| Study group | Role | What they receive |
|---|---|---|
| pregnancy test | Other | pregnancy tests Receives: Diagnostic Test: home pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Demonstration of volunteer preference for a HPTs.
- The cumulative scores on a 7-point likert scale for ease of use questions on the device usability at home questionnaire, where 1 equals very good and 7 equals very poor for each attribute.
Measured: 1 week
2. Demonstration of volunteer readability of HPTs
- The cumulative scores on a 7-point likert scale for readability questions on the device readability at SPD questionnaire, where 1 equals very easy and 7 equals very difficult for each attribute.
Measured: 1 week
3. Demonstration of consumer preference for a HPT
- The ranking of each Home Pregnancy Test in order of preference
Measured: 1 week
Secondary outcomes (2)
1. Accuracy of reading
The per cent agreement (accuracy) between the result read by the volunteer and true result for each standard tested (i.e 0 hCG will be not pregnant and 25mIU/ml hCG will be pregnant) for each Home pregnancy test evaluated.
Measured: 1 week
Agreement of reading
The agreement between volunteer home pregnancy test results and those of a technician testing the same urine standard (volunteer vs. technician test result)
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 posted18 Jul 2018
- Study start6 Jun 2018
- Primary completion13 Aug 2018
- Study completion13 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy TestingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589534
- Sponsor's protocol ID
- PROTOCOL-0972
- Status last verified
- Jul 2018
- First submitted
- 6 Jun 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boxer J, Weddell S, Broomhead D, Hogg C, Johnson S. Home pregnancy tests in the hands of the intended user. J Immunoassay Immunochem. 2019;40(6):642-652. doi: 10.1080/15321819.2019.1671861. Epub 2019 Sep 26.
PubMed 31556778
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Pregnancy Test Evaluation Study
- ClinicalTrials.gov ID
- NCT03589534
- Acronym / sponsor ID
- PROTOCOL-0972
- Conditions
- Pregnancy Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 13 Aug 2018 (actual)
- Study completion
- 13 Aug 2018 (actual)
- First posted
- 18 Jul 2018 (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 will evaluate consumer preference and consumer results from a number of commercially available home pregnancy tests.
The study is being conducted as a formal assessment home pregnancy tests sold in Western Europe.
Detailed description
The study will be conducted in two parts:
Part 1: Volunteers representative of pregnancy test users will use a range (4 of 7 different tests being evaluated) in their own home to gain usability data. All products will be used according to their instructions for use which, where required, will be translated into English prior to the study start. A study questionnaire will be completed after each test is used.
Part 2: The volunteers will attend the study site soon after completing their last home test and be required to read randomised results of tests conducted by study technicians (pregnant and not pregnant) to gain an understanding of their ability to correctly read results of the tests. The technician will also read and record the test results to enable both the laboratory agreement (technician read) and the consumer readability to be determined and compared for each product.
Each volunteer will be required to provide a urine sample for determining pregnancy status and quantitative urinary hormone measurement (this is done to confirm the result obtained at home using the HPTs).
At the end of the testing period the volunteers will also be asked to rank the four products they have used in the study, based on a series of statements regarding usability and readability of the tests
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pregnancy test | Other | Diagnostic Test: home pregnancy testpregnancy tests |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Aged 18-45 years
- Willing to give informed consent
- Willing to conduct a personal home pregnancy test and reveal their pregnancy status
Key exclusion criteria (4 listed)
- Currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott, or affiliates
- Has an immediate relative* currently or previously employed by SPD, Alere, Unipath, P\&G, Abbott or affiliates
- Taken a hormonal preparation containing hCG in the last month, e.g. Pregnyl®
- Recently miscarried and yet to have 2 complete menstrual cycles before study start
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 testEach participant will use 4 different home pregnancy tests | Diagnostic test | pregnancy test |
Primary outcome
1. Demonstration of volunteer preference for a HPTs.
Time frame: 1 week
• The cumulative scores on a 7-point likert scale for ease of use questions on the device usability at home questionnaire, where 1 equals very good and 7 equals very poor for each attribute.
2. Demonstration of volunteer readability of HPTs
Time frame: 1 week
• The cumulative scores on a 7-point likert scale for readability questions on the device readability at SPD questionnaire, where 1 equals very easy and 7 equals very difficult for each attribute.
3. Demonstration of consumer preference for a HPT
Time frame: 1 week
• The ranking of each Home Pregnancy Test in order of preference
2 secondary outcomes
1. Accuracy of reading
Time frame: 1 week
Agreement of reading
Time frame: 1 week
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 Nov 2018.
- Derived from this study: PubMed 31556778Boxer J, Weddell S, Broomhead D, Hogg C, Johnson S. Home pregnancy tests in the hands of the intended user. J Immunoassay Immunochem. 2019;40(6):642-652. doi: 10.1080/15321819.2019.1671861. Epub 2019 Sep 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home pregnancy test in people with Pregnancy Testing, 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 4 inclusion and 4 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 Nov 2018. 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?
1. Demonstration of volunteer preference for a HPTs. (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03589534, which also lists 1 linked publication.
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 Nov 2018.