Clearblue Pregnancy Test Lay User Usage Study
Launched by SPD DEVELOPMENT COMPANY LIMITED · Feb 4, 2021
Trial Information
Current as of August 02, 2025
Completed
Keywords
ClinConnect Summary
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 meth...
Gender
FEMALE
Eligibility criteria
- 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
About Spd Development Company Limited
SPD Development Company Limited is a leading biopharmaceutical organization dedicated to advancing innovative therapies through rigorous clinical research. With a focus on developing novel treatments across various therapeutic areas, SPD Development emphasizes scientific excellence, patient safety, and regulatory compliance. By leveraging a collaborative approach, the company aims to expedite the delivery of transformative healthcare solutions while adhering to the highest standards of quality and ethics in clinical trials.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cypress, California, United States
Patients applied
Trial Officials
Sarah Johnson, PhD
Study Director
SPD Development Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials