Community-informed maternal sepsis safety bundle in NYC hospitals (Aim 1)
EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 33183 (estimated) |
| Sex | Female |
| Sponsor | Columbia University Academic / other |
| Locations | 4 sites (New York, New York and 3 other locations) |
| Trial ID | NCT06145724 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.