Actively Recruiting

Age: 14Years +
FEMALE
Healthy Volunteers
ID07304531

First To Know Pregnancy Test Clinical Evaluation Protocol

Led by NOWDiagnostics, Inc. · Updated on 2025-12-26

1705

Participants Needed

2

Research Sites

4 weeks

Total Duration

On this page

Sponsors

N

NOWDiagnostics, Inc.

Lead Sponsor

M

MCRA

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the First To Know4 Pregnancy test, an investigational device adapted from the FDA-cleared ADEXUSDx4 hCG test, for potential over-the-counter use by lay users in a simulated home setting. The study involves females with unknown pregnancy status across different age groups, including pre-menopausal, peri-menopausal, and post-menopausal women, assessing how well the test performs compared to standard blood-based pregnancy tests. The study is organized into two cohorts: Cohort A, which includes up to 100 pregnant participants divided into three age groups, will perform self-testing and provide blood samples for comparison with a reference method. Cohort B consists of a subset of Cohort A participants who will perform duplicate self-tests consecutively to evaluate the test's accuracy and precision. Participants will test themselves and interpret results independently without assistance. Participants will self-administer the pregnancy test and provide blood samples for comparison. Negative results will be followed up to confirm pregnancy status, and positive results will be verified using standard care data. The study will track outcomes over an average of six months, measuring the test's accuracy, sensitivity, specificity, usability, and precision in real-world conditions. Participants will also provide information about their pregnancy diagnosis from their healthcare provider's follow-up visits.

CONDITIONS

Brief Title

First To Know Pregnancy Test - Clinical Evaluation Protocol

Who Can Participate

Age: 14Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Female with unknown pregnancy status who has not used a urine pregnancy test at home
  • Age 14 to 40 years with regular menstrual cycles (25-35 days) for pre-menopausal cohort
  • Age 41 to 54 years for peri-menopausal cohort
  • Age 55 years or older for post-menopausal cohort
  • Not menstruating at the time of the initial study visit
  • Willing to complete all study activities including testing and specimen collection
  • Willing to provide information about pregnancy diagnosis or follow-up care
  • Sexually active
  • Not using contraceptives
  • Able to speak English or Spanish
Not Eligible

You will not qualify if you...

  • Male
  • Females younger than 14 years
  • Recent pregnancy within the past 6 months
  • History of trophoblastic disease or non-trophoblastic tumors
  • Diagnosis of Down syndrome (trisomy 21)
  • Limited or no reading skills
  • Amenorrhea not related to peri-menopause or post-menopause
  • Use of medications or hormonal contraceptives that may affect hCG levels (e.g., gonadotropins like luteinizing hormone) at testing time

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 6 months

Participants self-administer the First To Know Pregnancy Test and provide blood samples for comparator testing. Positive test results are confirmed by standard of care assessments.

1 visit for testing and blood draw; follow-up contacts as needed for confirmation

Long-term Monitoring

Duration - Up to 6 months

Participants with negative test results are followed up to confirm pregnancy status and assess test performance over time.

Follow-up assessments as needed over study period

Trial Site Locations

Total: 2 locations

1

Matrix Clinical Research Los Angeles

Los Angeles, California, United States, 90057

Actively Recruiting

2

ERA Health Research

Midland, Texas, United States, 79707

Actively Recruiting

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Research Team

M

Monica Healy

C

Crystal Casto, MS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

Frequently Asked Questions

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