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Study Comparing Clara Pregnancy Test to Professional Tests

This study is looking at how well a new home pregnancy test, the Clara Pregnancy Test, compares to professional pregnancy tests. Researchers want to see if the results you get at home match the results from tests done by healthcare professionals. You can join if you are a woman, at least 18 years old, and can read and write in English or Spanish. To participate, you'll use the Clara Pregnancy Test at the study center and provide a urine sample. You'll also fill out questionnaires about the test and its instructions. The study aims to understand how well the Clara Pregnancy Test works for everyday users compared to professional tests. The current status of this study is unclear, and it plans to enroll around 180 participants.

Study design
This is an observational study involving about 180 participants. It compares results from the Clara Pregnancy Test used by participants to those from professional tests used by healthcare providers.
What's involved
You will conduct a home pregnancy test at the study center, provide a urine sample, and complete product usage and leaflet comprehension questionnaires.
Compensation
Not stated in the trial record.
Follow-up
Your pregnancy status will be determined by laboratory tests and clinical information, with the primary comparison measured at 1 day.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06516211

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

Not Yet Recruiting
Not specifiedAges 18+Observational
Conceptra Biosciences, LLC
~180 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:Clara Pregnancy TestProfessional Marketed Pregnancy Test

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lay-Professional Comparison
Measured over 1 day

Conditions

Pregnancy

Explore related trials

Pregnancy

Where it's being run

1 sites across 1 states
California1

Who to contact

Regulatory Conceptra
[email protected]
855-692-5272
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Lay-Professional Comparison1 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.