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Can listening to mothers prevent sepsis deaths? new study aims to find out.

NCT ID NCT06160349

Knowledge-focused Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at how social factors like poverty and race affect care for mothers with sepsis, a leading cause of death after childbirth in the U.S. Researchers will interview 200 Spanish- or English-speaking women who recently gave birth and had infection warning signs, plus community experts. The goal is to create a better care model that reduces death and disability from maternal sepsis.

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 200 people

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

Started

Jul 2023

Expected to finish

Sep 2026

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

For patient interviews- Adult women have a birthing experience in Columbia, Allen, Lincoln, or Harlem Hospitals within the past 8 weeks of enrollment For focus groups- stakeholders with academic/professional backgrounds relevant to maternal health

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Patient Interviews: * Speak Spanish or English * Be 18 years or older * Have a birthing experience in Columbia, Allen, Lincoln, or Harlem Hospitals within the past 8 weeks of enrollment * Have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum Community Stakeholder Focus Groups: * Speak English or Spanish * Be 18 years or older * Have academic/professional background relevant to maternal health in New York City. Exclusion Criteria: Patient Interviews * Under 18 years old * Speaks a language other than Spanish or English * Gave birth in a hospital other than Columbia, Allen, Lincoln, or Harlem Hospitals * Did not have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum Community Stakeholder Focus Groups * Under 18 years old * Speaks a language other than Spanish or English * Does not have a academic/professional background relevant to maternal health in New York City.

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Conditions

The condition(s) this trial relates to.

Infections infectious disease Pregnancy Complications, Infectious

As listed by the trial registrant

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

Infections Maternal sepsis

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Columbia Unviersity Medical Center

    New York, New York, 10032, United States

  • NYC Health + Hospitals/Lincoln

    The Bronx, New York, 10451, United States

  • NYC Health+Hospitals/Harlem

    New York, New York, 10037, United States

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