Validation Study of the Enlighten Blood Test for Predicting Postpartum Depression in Pregnant Women

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.

Clinical Validation of a Predictive Test for Postpartum Depression