Actively Recruiting
Clinical Validation of a Predictive Test for Postpartum Depression
Led by University of Virginia · Updated on 2025-12-03
500
Participants Needed
2
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a blood test called the Enlighten Device to predict postpartum depression (PPD) in pregnant women. This observational study aims to validate the test by determining its accuracy in identifying women who develop PPD within 3 months after delivery. The study also explores clinical factors like medication use, stressful life events, and sociocultural context that might affect test accuracy. Up to 500 pregnant women aged 18 or older with a single pregnancy are being recruited for this research. Participants will be enrolled before 30 weeks of gestation during their third trimester. They will have blood collected between 27 and 30 weeks of pregnancy to complete the Enlighten Device test, which measures epigenetic biomarkers. No results from this investigational test will be shared with participants. Following delivery, participants will be interviewed and assessed for depression symptoms at 2 weeks, 6 weeks, 3 months, and 6 months postpartum. Throughout the study, researchers will collect data on depression symptoms and other outcome measures at each postpartum visit. The main outcome is the percentage of true and false positive and negative PPD results as identified by the test at 6 months postpartum. This study is led by the University of Virginia and involves regular follow-ups to understand how well the blood test predicts PPD and factors that influence its accuracy.
CONDITIONS
Brief Title
Clinical Validation of a Predictive Test for Postpartum Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with a singleton pregnancy
- Less than 30 weeks pregnant
- Age 18 years or older
- Able to provide written consent in English
You will not qualify if you...
- Anyone deemed unsafe to participate by the study team or principal investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During the third trimester
Participants undergo the Enlighten Device test during the third trimester to assess biomarker status for postpartum depression risk.
1 visit (in-person)
Duration - Up to 3 months postpartum
Participants are monitored for depression symptoms outcome data collected up to 3 months postpartum.
Follow-up assessments at 3 months postpartum
Trial Site Locations
Total: 2 locations
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
2
Inova Health System
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
M
Meeta Pangtey, MPH
L
Lauren A Williamson, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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