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Simple blood test may spot postpartum depression risk during pregnancy

NCT ID NCT06831968

Diagnosis Sponsor: University of Virginia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new blood test called the Enlighten Device to see if it can predict which pregnant women will develop postpartum depression (PPD). Researchers will collect blood from 500 pregnant women in their third trimester and then follow them for 6 months after birth to track depression symptoms. The goal is to see if the test can accurately identify women at high risk, so they can get early support. The test is still investigational and not yet approved by the FDA.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enlighten Device (blood-based epigenetic biomarker test)
What this could lead to
If successful, this blood test could help identify pregnant women at risk for postpartum depression, allowing for early monitoring or support.
What could go wrong
This is an early-stage observational study, not yet FDA-approved. The test may not accurately predict depression, and results are not shared with participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Up to 500 pregnant women, aged 18 years or above

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

postpartum depression

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postpartum depression (PPD) Pregnancy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Inova Health System

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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