Home test to predict postpartum depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Study coordinator: Meeta Pangtey, MPH
• Email: uwp7jh@uvahealth.org
• Phone: 434-987-7367

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.