PregnancyNCT02636166
Project-0027. Lay User Usage Study
A study testing Clearblue Investigational Pregnancy test, Professional pregnancy test and Clearblue Marketed Pregnancy test in people with Pregnancy, run by SPD Development Company Limited at 1 site in United Kingdom.
Trial summary
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing. Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Clearblue Investigational Pregnancy test, Professional pregnancy test and Clearblue Marketed Pregnancy test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 943 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Dec 2015
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- Aged 18 or over
- Willing to conduct a personal pregnancy test and reveal their pregnancy status
- Willing to give informed consent
Who cannot join
- Currently or previously employed by SPD Development Company Ltd. (SPD), Alere, Unipath, Procter and Gamble (P\&G), or affiliates.
- Has an immediate relative* currently or previously employed by SPD, Alere, Unipath or P\&G or affiliates
- Previously used the investigational HPT within the last six months
- Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing
- Confirmed to be pregnant by a healthcare professional and beyond the first trimester
- Taken a hormonal preparation containing human chorionic gonadotropin (hCG) in the last month, e.g. Pregnyl®
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Illingworth Research Ltd
Macclesfield, Chester, SK11 7QJ
About this study
Official title: Project-0027 Lay User Usage Study
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing.
Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.
Read the detailed description
Eligible volunteers will be recruited into the study and provide informed consent. Volunteers will then test their urine sample with the investigational HPT according to the device Instructions for use and record their result onto the results sheet. A sample of urine from the same void will be obtained for further testing by the study technicians.
The technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a Clearblue Digital HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.
At the end of the study visit, all volunteers will be provided with materials to allow follow-up for the determination of pregnancy status.
The majority of volunteers will be requested to provide one additional urine sample, collected 2 days after the study visit. If early pregnancy is suspected the volunteer will be requested to provide an additional 7 daily urine samples following the study visit. All volunteers will be required to provide details of pregnancy status (documented menses or pregnancy confirmation by health care professional) after the study visit.
True pregnancy status will be determined by laboratory tests and clinical information. The study will continue until a minimum of 300 pregnant and 300 not pregnant volunteers have completed the study.
- Conditions
- Pregnancy
- Being tested
- Clearblue Investigational Pregnancy test, Professional pregnancy test, Clearblue Marketed Pregnancy test
- Keywords
- Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clearblue Investigational Pregnancy testOther
Clearblue Investigational Pregnancy test
Professional pregnancy testOther
Alere Professional use pregnancy test
Clearblue Marketed Pregnancy testOther
Clearblue Marketed Pregnancy test
| Study group | Role | What they receive |
|---|---|---|
| Pregnancy test | Other | Clearblue investigational Pregnancy test
Clearblue Marketed pregnancy test
Professional pregnancy test Receives: Other: Clearblue Investigational Pregnancy test; Other: Professional pregnancy test; Other: Clearblue Marketed Pregnancy test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status
The accuracy of the investigational HPT in volunteer hands compared to pregnancy status
Measured: 3 months
Secondary outcomes (5)
Number of participants recording the same pregnancy test result as a laboratory technician when testing their own urine sample with the investigational HPT.
The agreement between volunteer and technician results using the investigational HPT
Measured: 3 months
Number of participants recording a false positive or false negative pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status.
The estimated sensitivity and specificity of the investigational HPT
Measured: 3 months
Calculation of the level of certainty a user can have if the device gives a pregnant (positive predictive value (PPV)) or not pregnant result (Negative predictive value(NPV)).
The estimated NPV and PPV of the investigational HPT
Measured: 3 months
Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet.
Volunteer leaflet comprehension of the IFU
Measured: 3 months
Participants opinion on using the product.
Volunteer usability of the IFU
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 posted21 Dec 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionDec 2015
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 943 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPD Development Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Illingworth Research Ltd
- Responsible party
- Sponsor
- Investigators
- Juliet Hulse, Principal investigator, Illingworth Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636166
- Sponsor's protocol ID
- PROTOCOL-0772
- Status last verified
- Oct 2015
- First submitted
- 20 Oct 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project-0027 Lay User Usage Study
- ClinicalTrials.gov ID
- NCT02636166
- Acronym / sponsor ID
- PROTOCOL-0772
- Conditions
- Pregnancy
- Keywords
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 943 participants (actual)
- Lead sponsor
- SPD Development Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Illingworth Research Ltd
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Dec 2015 (estimated)
- 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.
Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial centre and provide a sample of urine from the same void for further testing.
Volunteers will then complete a product usage questionnaire and leaflet comprehension questionnaire at site.
Follow-up information will be required from all volunteers as both additional urine sample(s) and pregnancy information to establish true pregnancy status at the study visit.
Detailed description
Eligible volunteers will be recruited into the study and provide informed consent. Volunteers will then test their urine sample with the investigational HPT according to the device Instructions for use and record their result onto the results sheet. A sample of urine from the same void will be obtained for further testing by the study technicians.
The technician will then test the volunteer's sample with a second investigational HPT, a professional use pregnancy test and a Clearblue Digital HPT, the results of which will be used to provide the volunteer with her pregnancy test result. During technician testing, the volunteer will complete the device usability and leaflet comprehension questionnaires.
At the end of the study visit, all volunteers will be provided with materials to allow follow-up for the determination of pregnancy status.
The majority of volunteers will be requested to provide one additional urine sample, collected 2 days after the study visit. If early pregnancy is suspected the volunteer will be requested to provide an additional 7 daily urine samples following the study visit. All volunteers will be required to provide details of pregnancy status (documented menses or pregnancy confirmation by health care professional) after the study visit.
True pregnancy status will be determined by laboratory tests and clinical information. The study will continue until a minimum of 300 pregnant and 300 not pregnant volunteers have completed the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnancy test | Other | Other: Clearblue Investigational Pregnancy test, Other: Professional pregnancy test, Other: Clearblue Marketed Pregnancy testClearblue investigational Pregnancy test Clearblue Marketed pregnancy test Professional pregnancy test |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- Aged 18 or over
- Willing to conduct a personal pregnancy test and reveal their pregnancy status
- Willing to give informed consent
Key exclusion criteria (6 listed)
- Currently or previously employed by SPD Development Company Ltd. (SPD), Alere, Unipath, Procter and Gamble (P\&G), or affiliates.
- Has an immediate relative* currently or previously employed by SPD, Alere, Unipath or P\&G or affiliates
- Previously used the investigational HPT within the last six months
- Healthcare professionals (HCP's) with professional experience either using lateral flow based devices or conducting near patient testing
- Confirmed to be pregnant by a healthcare professional and beyond the first trimester
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 Investigational Pregnancy testClearblue Investigational Pregnancy test | Other | Pregnancy test |
| Professional pregnancy testAlere Professional use pregnancy test | Other | Pregnancy test |
| Clearblue Marketed Pregnancy testClearblue Marketed Pregnancy test | Other | Pregnancy test |
Primary outcome
Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status
Time frame: 3 months
The accuracy of the investigational HPT in volunteer hands compared to pregnancy status
5 secondary outcomes
Number of participants recording the same pregnancy test result as a laboratory technician when testing their own urine sample with the investigational HPT.
Time frame: 3 months
Number of participants recording a false positive or false negative pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status.
Time frame: 3 months
Calculation of the level of certainty a user can have if the device gives a pregnant (positive predictive value (PPV)) or not pregnant result (Negative predictive value(NPV)).
Time frame: 3 months
Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet.
Time frame: 3 months
Participants opinion on using the product.
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 21 Dec 2015.
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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.
Juliet Hulse principal investigator
Illingworth Research Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clearblue Investigational Pregnancy test, Professional pregnancy test and Clearblue Marketed Pregnancy test in people with Pregnancy, 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 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 21 Dec 2015. 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?
Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed 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 21 Dec 2015.