Clinical Validation of a Predictive Test for Postpartum Depression (PREVAIL)

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: 80% or greater of pregnant women who develop PPD by 3 months after delivery will be determined to be Biomarker Positive by the Enlighten Device in T3.

Primary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Device in T3 will develop PPD by 3 months after delivery.

Exploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, and sociocultural context.

Participants will be screened during the second or third trimester and enrolled during the third trimester, before week 30 weeks of gestation. Participants may self- identify through study advertisements in participating clinics, social media outlets, and community outreach efforts. Enrolled participants will undergo blood collection during their 3rd trimester (~27-30 weeks, a standard pregnancy-related blood collection timepoint) for completion of the Enlighten Device test, the blood-based epigenetic biomarker test. Participants will then be interviewed at 2 weeks, 6 weeks, 3 months, and 6 months postpartum for the development of depression symptoms. They'll also complete a multitude of other outcome measures at each of these visits.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Postpartum Depression (PPD)
• Intervention / Treatment: Diagnostic test: Enlighten

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Meeta Pangtey, MPH; Phone Number: 434-987-7367; Email: uwp7jh@uvahealth.org
• Study Contact Backup: Name: Lauren A Williamson, PhD; Phone Number: 434-987-7369; Email: lea6d@uvahealth.org

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Health System
      • Principal Investigator: Scott A Sullivan, MD
      • Contact: Scott A Sullivan, MD; Phone Number: 843-817-9046; Email: Scott.Sullivan@inova.org
      • Contact: Miranda Newell, MS; Phone Number: 703-776-4600; Email: Miranda.newell@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Up to 500 pregnant women, aged 18 years or above

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants with True/False Positive and Negative PPD Outcomes as Assessed by the Enlighten Device	PPD diagnosis will be confirmed by clinical evaluation using the Structured Clinical Interview for the DSM-5 Research Version (SCID-5-RV) and Edinburgh Postnatal Depression Scale (EPDS), at the time of enrollment and subsequent study visits. True positive/negative and false positive/negative classifications will be based on the Enlighten Device's biomarker threshold values in T3 (third trimester). Data will be aggregated as percentages and compared to clinical PPD diagnoses. Primary Hypothesis H1b: 10% or fewer of pregnant women who are determined to be Biomarker Negative by the Enlighten Device in T3 will develop PPD by 3 months after delivery. Exploratory Aim 1: Investigation of clinical factors that may be associated with false positive and false negative rates, such as: medication use, stressful life events, and sociocultural context.	6 months postpartum

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Jennifer L Payne, MD, University of Virginia; Principal Investigator: Andrea Cubitt, PhD, Dionysus Digital Health, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): July 31, 2028

Study Registration Dates

• First Submitted: January 17, 2025
• First Submitted That Met QC Criteria: February 12, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Postpartum Depression; Pregnancy; Blood Test; Third Trimester; Predictive Test
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Mood Disorders; Puerperal Disorders; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: PR230933; HT94252410544 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to share de-identified data with other researchers. Data shared will include demographic information, clinical data which will include SCID diagnosis, mental health surveys like EPDS, PASS, etc., sample analyses data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No