Validating the Enlighten Device to Predict Postpartum Depression Using At-Home Blood and Saliva Samples in Pregnant Women

What this Trial Is About

Researchers are evaluating the Enlighten Device to predict postpartum depression PPD by assessing its accuracy through true and false positive and negative rates based on outcomes collected up to 3 months after delivery. The study includes pregnant women aged 18 and older up to 33 weeks of gestation and aims to compare biomarker accuracy between blood and saliva samples and to assess the devices ability to identify women currently experiencing PPD at 6 weeks postpartum. Participants will be enrolled before 30 weeks of gestation and undergo blood collection during the third trimester at around 27 to 30 weeks, performed by mobile phlebotomists at home. The study will analyze biomarker results from the Enlighten Device using blood samples and compare these to saliva samples. Follow-up assessments occur at 2 weeks, 6 weeks, and 3 months postpartum to monitor depression symptoms and other health outcomes. Throughout the study, participants will complete interviews and various outcome measures at each postpartum visit. The main outcome is the percentage of participants with true or false positive and negative PPD results as determined by the Enlighten Device six months after delivery. The study also explores clinical factors influencing test accuracy and epigenetic markers to improve prediction. The total study period includes screening in the second or third trimester, third trimester sample collection, and postpartum follow-up visits.

A Study of a Test for Postpartum Depression at Home