Pregnancy
Conditions
Keywords
Pregnancy
Brief 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. 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.
Interventions
OTHERProfessional pregnancy test
Alere Professional use pregnancy test
OTHERClearblue Marketed Pregnancy test
Clearblue Marketed Pregnancy test
OTHERClearblue Investigational Pregnancy test
Clearblue Investigational Pregnancy test
Sponsors
Illingworth Research Ltd
SPD Development Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Female * Aged 18 or over * Willing to conduct a personal pregnancy test and reveal their pregnancy status * Willing to give informed consent
Exclusion criteria
* 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®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants recording the correct pregnancy test result when testing their own urine sample with the investigational HPT referenced to confirmed pregnancy status | 3 months | The accuracy of the investigational HPT in volunteer hands compared to pregnancy status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants recording the same pregnancy test result as a laboratory technician when testing their own urine sample with the investigational HPT. | 3 months | The agreement between volunteer and technician results using the investigational HPT |
| 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. | 3 months | The estimated sensitivity and specificity of the investigational HPT |
| 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)). | 3 months | The estimated NPV and PPV of the investigational HPT |
| Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet. | 3 months | Volunteer leaflet comprehension of the IFU |
| Participants opinion on using the product. | 3 months | Volunteer usability of the IFU |
Countries
United Kingdom
Outcome results
None listed