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Clinical Trials in the USA / NCT06516211
Starting soon Observational

Predicate and Lay User-HCP Comparison Study of a Multi-Level Urine hCG Pregnancy Test

NCT06516211 · tracked via the Priya Life Science USA tracker
Sponsor
Conceptra Biosciences, LLC
Phase
Observational
Started
2027-01-30
Last updated
2026-10-26

Condition(s) studied

Pregnancy

Investigational drug(s) / intervention(s)

Clara Pregnancy TestProfessional Marketed Pregnancy Test

Clara Pregnancy Test: Multi-Level Pregnancy Test

Professional Marketed Pregnancy Test: Early Pregnancy Test

Study summary

Study volunteers will be required to conduct a home pregnancy test (HPT) at the trial center 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Females (persons assigned female at birth and not sterile) willing and able to provide written consent to Study participation * Able to read and write in English or Spanish Exclusion criteria: * Persons employed in a healthcare or laboratory setting and/or with professional experience who conduct point of care urine tests * Previous or current enrollment in a Clara™ Study * Visually or otherwise impaired to a degree they are not able to readily read and follow instructions, or visualize the faint pink lines. * Unwilling or unable to provide at least 12mls of urine specimen and any urine testing they are expected to receive as a part of their non-Study related care.

Primary outcome measure(s)

  • Lay-Professional Comparison — 1 day
    Demonstration of agreement of pregnancy test reading. The agreement between lay participant test results and those of a technician testing the same urine sample.

Trial sites (1)

FacilityCityRegionStatus
FPA Women's Health Los Angeles California

Other trials for the same condition

External Trigeminal Nerve Stimulation for Migraine Treatment in Pregnancy Recruiting
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy Recruiting
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy Enrolling by invitation
Cocooned Moms Study Recruiting
A Study to Assess the Pregnancy Outcome in Women Exposed to Dayvigo® During Pregnancy Compared to an Unexposed Control Population Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06516211 on ClinicalTrials.gov ↗ ← All trials in the USA