A Study of the Enlighten Device for Postpartum Depression
This study is testing a new device called Enlighten to see if it can predict postpartum depression (PPD) in pregnant women. The Enlighten device will look at your biomarker status (whether you have an "elevated risk" or "low risk") during your third trimester. Researchers will then compare these results to your actual depression symptoms up to three months after you give birth. The goal is to see how accurate the Enlighten device is at identifying women who might develop PPD. You can join if you are pregnant with one baby, are at least 18 years old, and are less than 30 weeks pregnant. The study aims to enroll 1000 participants.
- Study design
- This is an observational study, meaning researchers will observe and collect information without giving any specific treatment. It plans to include 1000 pregnant women.
- What's involved
- The study will involve collecting samples during your pregnancy and then gathering information about your depression symptoms up to three months postpartum. There will also be a sample collection at week 6 postpartum.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for outcomes related to postpartum depression up to 6 months after giving birth.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of a Test for Postpartum Depression at Home
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Percentage of Participants with True/False Positive and Negative PPD Outcomes as Assessed by the Enlighten Device6 months postpartum
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.