Skip to main content
OpenTrials
Completed

NCT Number: NCT02636166

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Illingworth Research Ltd

Macclesfield, Chester, SK11 7QJ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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®

Treatment and study plan

Clearblue Investigational Pregnancy test

Other

Clearblue Investigational Pregnancy test

Professional pregnancy test

Other

Alere Professional use pregnancy test

Clearblue Marketed Pregnancy test

Other

Clearblue Marketed Pregnancy test

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    The agreement between volunteer and technician results using the investigational HPT

  2. 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

    The estimated sensitivity and specificity of the investigational HPT

  3. 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

    The estimated NPV and PPV of the investigational HPT

  4. Number of participants correctly answering questions about the product when referencing the instructions for use (IFU) leaflet.

    Time frame: 3 months

    Volunteer leaflet comprehension of the IFU

  5. Participants opinion on using the product.

    Time frame: 3 months

    Volunteer usability of the IFU

Sponsors and collaborators

Lead sponsor

SPD Development Company Limited

Industry

Collaborators

  • Illingworth Research Ltd

Registry information

Official study title

Project-0027 Lay User Usage Study

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Dec 21, 2015
Registry last updated
Dec 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.