Project-0027. Lay User Usage Study

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: Clearblue Investigational Pregnancy test; Other: Professional pregnancy test; Other: Clearblue Marketed Pregnancy test

• Registration Number: NCT02636166
• Lead Sponsor: SPD Development Company Limited

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.

Study Timeline

• Study Start: 2015-07
• Status Verified: 2015-10
• Study First Submitted: 2015-10-20
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Study First Submitted QC: 2015-12-16
• Last Update Submitted: 2015-12-16
• Study First Posted: 2015-12-21
• Last Update Posted: 2015-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 943

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®

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pregnancy test	Clearblue Investigational Pregnancy test	Clearblue investigational Pregnancy test Clearblue Marketed pregnancy test Professional pregnancy test
Pregnancy test	Professional pregnancy test	Clearblue investigational Pregnancy test Clearblue Marketed pregnancy test Professional pregnancy test
Pregnancy test	Clearblue Marketed Pregnancy test	Clearblue investigational Pregnancy test Clearblue Marketed pregnancy test Professional pregnancy test

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

Illingworth Research Ltd; 🇬🇧 Macclesfield, Chester, United Kingdom