Clinical Validation of a Predictive Test for Postpartum Depression
NCT06831968
This study is recruiting at 2 US sites in 1 state, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Postpartum Depression (PPD)
- Pregnancy
Eligibility basics and study details
- Study type
- Observational
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- Female
- Healthy volunteers
- Accepted
- Sponsor
- University of Virginia
- Last updated on ClinicalTrials.gov
- December 3, 2025
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
Virginia · 2
- University of Virginia · Charlottesville, VA
- Inova Health System · Falls Church, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.