Community-informed maternal sepsis safety bundle in NYC hospitals (Aim 1)
Official title: EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle
Run by Columbia University · NCT06145724 · Data updated 2026-11-12
This project will try a community-informed maternal sepsis safety bundle in four New York City hospitals to reduce sepsis during labor, birth, and the postpartum period for birthing people.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | Women only |
| Enrollment | 33183 (estimated) |
| Sponsor | Columbia University Academic / other |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Status | Recruiting |
| Started | June 1, 2025 |
| Main results expected | August 31, 2026 |
| Study ends | September 20, 2026 |
| Registry record updated | January 21, 2026 |
| Trial ID | NCT06145724 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Birthing people who had delivery hospitalizations or associated postpartum readmissions at one of the four participating hospitals between 2020 and 2025 are the focus of this work.
✕Probably not a fit
People who deliver at hospitals outside the four participating sites or whose care occurred outside the 2020–2025 window would not be included and therefore would not receive any direct benefit from this implementation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
EnCoRe MoMS partners community leaders, clinicians, and researchers to design and implement a maternal sepsis safety bundle across four New York City hospitals. Aim 1a established community engagement structures and a CoLAB to create a bundle that combines readiness, recognition, response, reporting, respectful care, provider training, and screening for unmet needs. Aim 1b uses a pre–post implementation design with electronic health record review of delivery hospitalizations and related postpartum readmissions between 2020 and 2025 to compare outcomes before and after bundle rollout. Participants are followed through the delivery hospitalization to discharge and any pertinent readmissions to measure sepsis events and related morbidity.
Why it matters
Potential benefit: If successful, the bundle could reduce maternal sepsis cases, complications, and deaths by improving early recognition and standardizing timely responses.
How similar studies have gone: Professional groups (ACOG, SMFM) recommend sepsis safety bundles but direct evidence of their effectiveness is limited, and this community-informed, multi-center pre–post evaluation is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Birthing Person (EMR evaluation): -Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025 Exclusion Criteria: Birthing Person (EMR evaluation) -Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2020-2025 timeframe
Where it's running
-
Columbia Unviersity Irving Medical Center
New York, New York, United States Recruiting -
NewYork-Presbyterian Allen Hospital
New York, New York, United States Recruiting -
NYC Health+Hospitals/Harlem
New York, New York, United States Recruiting -
NYC Health + Hospitals/Lincoln
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: Dena Goffman, MD — Columbia University
- Study coordinator: Briana Richardson, MPH
- Email: br2724@cumc.columbia.edu
- Phone: 347-899-0486
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.