Pregnancy
Conditions
Keywords
Lay User
Brief summary
The Clearblue home pregnancy test (HPT) is an over the counter urine hCG (human chorionic gonadotrophin) visual pregnancy test which is intended for the detection of pregnancy. This study will assess the performance of the HPT in the hands of the lay user 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 HPT is an over the counter urine hCG visual-read test which is intended for the detection of pregnancy. This study aims to demonstrate that the pregnancy test has the required performance characteristics in lay user testing. The study will recruit a cross-section of the target pregnancy test user population, that is, women aged over 18 years representative of the intended user. A minimum of 300 women will be required to complete the study consisting of both pregnant and not pregnant volunteers. Each volunteer will conduct the pregnancy test using their preferred sampling method (either 'in-stream' or 'dip'). Volunteers will be evaluated against confirmed pregnancy status. Lay user comprehension of the device instructions and usability of the device will also be assessed.
Interventions
DIAGNOSTIC_TESTClearblue Pregnancy Test
Urine Pregnancy Test
Sponsors
WCCT Global
SPD Development Company Limited
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female * Aged 18 and over * Interested in conducting a personal 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
Exclusion criteria
* Significant affiliation with SPD * Used the investigational pregnancy test previously * Qualified or trainee healthcare professional (HCP) * Has professional experience (in current or previous job) of using dipstick type tests or lateral flow devices * Confirmed to be pregnant by a healthcare professional and beyond the first trimester (defined as last menstrual period (LMP) +13 weeks) * Has a medical condition that means that it is not appropriate to give a blood sample
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Clearblue Pregnancy Test | 3 days | Number of pregnancy tests in agreement with pregnancy status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Co-ordinator Agreement | 1 day | Number of lay users who record the same pregnancy test result as a trained study co-ordinator |
| Comprehension of Instructions for Use | 1 day | Number of volunteers who answer each comprehension question correctly |
| Device Usability | 1 day | Number of volunteers who record the device as easy to use |
Countries
United States
Outcome results
None listed