Home test to predict postpartum depression
A Prospective Validation of the Enlighten Device in Predicting Postpartum Depression Using At-Home Sample Collection in Both Blood and Saliva
University of Virginia · NCT07186309
This project will test whether the Enlighten blood or saliva test taken in late pregnancy can predict which pregnant women (age 18+, singleton pregnancies enrolled before 30 weeks) will develop postpartum depression in the first three months after birth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Virginia (other) |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT07186309 on ClinicalTrials.gov |
What this trial studies
This observational project will prospectively validate the Enlighten diagnostic test by collecting blood and saliva samples from about 1,000 pregnant women enrolled before 30 weeks' gestation and following them through three months postpartum to measure true and false positive and negative rates. The study will compare biomarker and algorithm performance in blood versus saliva and will include a week-6 postpartum sample to identify women who are currently experiencing PPD. Participants provide samples and symptom outcome data, with the primary outcome based on postpartum depression status within three months. The effort is led by the University of Virginia with collaborators including Mayo Clinic and Dionysus Health.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 or older with a singleton pregnancy who can consent in English and enroll before 30 weeks' gestation.
Not a fit: Women beyond the enrollment window (past 30 weeks), with multifetal pregnancies, who cannot consent in English, or who are already diagnosed and effectively treated for PPD are less likely to benefit from this predictive test.
Why it matters
Potential benefit: If successful, the test could help identify women at high risk for postpartum depression earlier so they can get monitoring or treatment sooner.
How similar studies have performed: Prior small studies of biomarker-based PPD prediction have shown promising but limited results, so this larger prospective validation is intended to provide stronger evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Charlottesville, Virginia
- University of Virginia — Charlottesville, Virginia, United States (RECRUITING)
Study contacts
- Study coordinator: Meeta Pangtey, MPH
- Email: uwp7jh@uvahealth.org
- Phone: 434-987-7367
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Depression, Pregnancy, Predictive Test, Blood Test, Third Trimester, Behavioral Symptoms, Mood Disorders, Mental Disorders