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โ† Trials
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Clinical Validation of a Predictive Test for Postpartum Depression

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 goal of this observational study is to develop a blood test that may be predictive of postpartum depression. This Blood test is investigational and not yet FDA approved. Participants will not receive the results of this blood test. Up to 500 pregnant women will be recruited for the study from 2 sites. Participants must be age 18 or above with a singleton pregnancy and able to provide written consent in English. The Objective of this Clinical Trial is to prospectively validate the Enlighten Device test by prospectively determining false/true positive and negative rates. Building off of this, an exploratory objective of this study is to examine clinical factors associated with false positive/negative rates. This project will address the following Aim: Aim 1: Prospective collection of true/false positive and negative PPD outcomes through 6 months postpartum. Primary Hypothesis H1a:

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

  • Enlighten
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Where

2 sites
University of Virginia
Charlottesville, United States
Inova Health System
Falls Church, 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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