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First To Know Pregnancy Test Evaluation

This study is evaluating the First To Know Pregnancy Test, which is designed for home use, to see how well it detects pregnancy. Researchers want to compare its accuracy and sensitivity to a standard blood test for pregnancy (quantitative blood-based hCG assay). You might be able to join if you are a woman aged 14 or older, and your pregnancy status is currently unknown. The study aims to enroll about 1705 participants. This is an observational study, meaning researchers will watch and record results without giving you a specific treatment. The study is currently unclear about its recruitment status.

Study design
This is an observational study with a planned enrollment of 1705 women. It includes different age groups to assess the test's performance.
What's involved
You would use the investigational First To Know Pregnancy Test yourself in a simulated home setting. Blood will also be drawn for comparison testing.
Compensation
Not stated in the trial record.
Follow-up
All negative test results will be followed up for outcome. Positive results or later reported pregnancies will be confirmed by standard medical assessments through study completion, an average of 6 months.

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NCT07304531

First To Know Pregnancy Test - Clinical Evaluation Protocol

Recruiting
Not specifiedAges 14+Observational
NOWDiagnostics, Inc.
~1,705 participants
Updated 2025-12-26 on ClinicalTrials.gov
What's tested:Diagnostic Test

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay
Measured over Through study completion, an average of 6 months

Conditions

Pregnancy Detection

Explore related trials

Pregnancy

Where it's being run

2 sites across 2 states
California1
Texas1

Who to contact

Monica Healy
[email protected]
240-498-3933
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Females whose pregnancy status is unknown (e.g., have not used urine test at home)
Age Selection - must meet one of the following age groups:
Cohort A1 - Pre-menopausal: ≥14 years of age and ≤ 40 years of age with menstrual cycles (cycle lengths of 25-35 days)
Cohort A2 - Peri-menopausal: ≥41 years of age and ≤ 54 years of age
Cohort A3 - Post-menopausal: ≥55 years of age
Not menstruating at the time of the initial study visit
Must be willing to complete all study activities, provide all specimens/samples, and conduct all required testing
Willing to provide information regarding the diagnosis of pregnancy or details from their standard of care follow-up visit after initial visit
Sexually active
Not using contraceptives
English/Spanish speaking

Exclusion

Males
Females \<14 years of age
Recent pregnancy within the past 6 months
Trophoblastic disease or non-trophoblastic neoplasms
Downs syndrome (trisomy 21)
People with limited or no reading skills
Amenorrhea not related to peri or post menopause
Use of medications or hormonal contraceptives that may interfere with hCG levels at the time of testing (e.g., Gonadotropins: Luteinizing hormone)

What this trial measures

  • Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assayThrough study completion, an average of 6 months

    Evaluate the accuracy and sensitivity of the First To Know Pregnancy test compared to a legally marketed quantitative blood-based hCG assay (e.g., Siemens Dimension® hCG Flex® Reagent Cartridge, Roche Cobas® Elecsys HCG STAT) as the clinical comparator