PregnancyNCT04043169
Clearblue Pregnancy Test - Lay User Study
An observational study of Pregnancy, run by SPD Development Company Limited at 1 site in United States.
Trial summary
The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users by comparing their results when used according to the instructions… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Clearblue pregnancy test
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2019to 31 Dec 2019
- 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
- Adult
Study population: Healthy pregnant, or not pregnant volunteers requiring or wishing to conduct a pregnancy test.
Who may be able to join
- Female
- Aged 18 to 45
- Willing to conduct a pregnancy test to determine or confirm their pregnancy status
- Willing to reveal their pregnancy status
- Willing to provide a blood sample
- Willing to give informed consent
Who cannot join
- Significant affiliation with SPD
- Has professional experience of using lateral flow-based devices
- Beyond the first trimester of pregnancy
- Taken a hormonal preparation containing hCG in the last month.
- Has a medical condition that means that it is not appropriate to give a blood.
Trial locations and contacts
1 site in 1 country.
About this study
The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.
Read the detailed description
The Clearblue product is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. The test is indicated for use from 6 days before the day of the missed period (5 days before the day of the expected period). The test is intended for home use.
This study aims to demonstrate that the Pregnancy Test has the required performance characteristics in lay-user testing, and when testing samples provided by lay-users. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged between 18 and 45 representative of the intended user.
A minimum of 204 volunteers will be required to complete the study. The study site will aim to recruit an equal number of pregnant and not-pregnant volunteers (a minimum of 102 of each). Each volunteer will conduct the pregnancy test using both the 'in stream' and 'dip' method of sampling. Volunteer results will be evaluated against confirmed pregnancy status.
- Conditions
- Pregnancy
- Being tested
- Clearblue pregnancy test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearblue pregnancy testDiagnostic test
Urine pregnancy test
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Clearblue pregnancy test
Number of pregnancy test results in agreement with clinical pregnancy status
Measured: 3 days
Secondary outcomes (3)
Sample method agreement
number of volunteers who record the same pregnancy test result using the 'in stream' and 'dip' method of sampling
Measured: 1 day
Coordinator agreement
number of volunteers who record the same pregnancy test result as a trained study coordinator
Measured: 1 day
Device usability
number of volunteers who record the device as easy to use
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start30 Jul 2019
- Primary completion30 Nov 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Responsible party
- Sponsor
- Investigators
- Sarah Johnson, Study director, SPD Development company Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04043169
- Sponsor's protocol ID
- PROTOCOL-0971
- Status last verified
- Jul 2019
- First submitted
- 1 Aug 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearblue Pregnancy Test - Lay User Study
- ClinicalTrials.gov ID
- NCT04043169
- Acronym / sponsor ID
- PROTOCOL-0971
- Conditions
- Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- WCCT Global
- Study start
- 30 Jul 2019 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Aug 2019 (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.
The Clearblue home pregnancy test (HPT) is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. This study will assess the performance of a HPT in the hands of lay-users by comparing their results when used according to the instructions for use (IFU) to (i) confirmed pregnancy status of the volunteers and (ii) to the results of trained study staff testing the same urine samples.
Detailed description
The Clearblue product is an over-the-counter urine hCG (human chorionic gonadotropin) integrated digital test which is intended for the detection of pregnancy. The test is indicated for use from 6 days before the day of the missed period (5 days before the day of the expected period). The test is intended for home use.
This study aims to demonstrate that the Pregnancy Test has the required performance characteristics in lay-user testing, and when testing samples provided by lay-users. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged between 18 and 45 representative of the intended user.
A minimum of 204 volunteers will be required to complete the study. The study site will aim to recruit an equal number of pregnant and not-pregnant volunteers (a minimum of 102 of each). Each volunteer will conduct the pregnancy test using both the 'in stream' and 'dip' method of sampling. Volunteer results will be evaluated against confirmed pregnancy status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Healthy pregnant, or not pregnant volunteers requiring or wishing to conduct a pregnancy test.
Key inclusion criteria (6 listed)
- Female
- Aged 18 to 45
- Willing to conduct a pregnancy test to determine or confirm their pregnancy status
- Willing to reveal their pregnancy status
- Willing to provide a blood sample
Key exclusion criteria (5 listed)
- Significant affiliation with SPD
- Has professional experience of using lateral flow-based devices
- Beyond the first trimester of pregnancy
- Taken a hormonal preparation containing hCG in the last month.
- Has a medical condition that means that it is not appropriate to give a blood.
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 |
|---|---|---|
| Clearblue pregnancy testUrine pregnancy test | Diagnostic test | – |
Primary outcome
Accuracy of Clearblue pregnancy test
Time frame: 3 days
Number of pregnancy test results in agreement with clinical pregnancy status
3 secondary outcomes
Sample method agreement
Time frame: 1 day
Coordinator agreement
Time frame: 1 day
Device usability
Time frame: 1 day
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 20 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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, run by SPD Development Company Limited at 1 site in United States.
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 6 inclusion and 5 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 20 Feb 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 States. 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?
Accuracy of Clearblue pregnancy test (time frame: 3 days). 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 20 Feb 2020.