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A Study of a Test for Postpartum Depression at Home

Recruitingn/aAges 18 Years - anyFemaleUniversity of Virginia
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In plain words

What the trial is, and whether it could suit you

The study will seek to prospectively validate the Enlighten Device for prediction of PPD by examining true/false positive and negative rates of the test using PPD outcomes collected through 3 months postpartum; compare the accuracy of biomarkers and algorithm in determining risk for PPD in blood compared to saliva; determine the utility of a week 6 sample collection in identifying women who are currently experiencing PPD thus bringing them to clinical attention. Our population will consist of pregnant women aged 18 and older up to 33 weeks of gestation. This research involves two groups of potentially vulnerable subjects: pregnant women and their infants. Because this is a study of postpartum depression (PPD), inclusion of these two vulnerable subjects is required. The study will enroll 1000 pregnant non-adolescent women of childbearing age who meet eligibility criteria. This project w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * subject must be pregnant (singleton pregnancy) * \<30 weeks' gestation, age 18 or above * able to provide written consent in English Exclusion Criteria: * The study team and/or PI may exclude anyone deemed unsafe to participate in the protocol.
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What it tests

  • Diagnostic Test: Enlighten
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Where

1 site
University of Virginia
Charlottesville, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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