EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 1)

January 20, 2026 updated by: Dena Goffman, Columbia University

EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle

Sepsis is the second leading cause of maternal death in the U.S. Labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. Labor, birth, and postpartum are periods of increased sepsis risk. While American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend the implementation of safety bundles to prevent maternal mortality as the standard of care, there is limited evidence regarding effectiveness. EnCoRe MoMS will directly evaluate safety bundle performance for maternal sepsis. With extensive community partnerships and community organized leadership advisory board (CoLAB), EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will develop, implement, and evaluate a community-informed maternal sepsis bundle in 4 New York City (NYC) hospitals.

In Aim 1a: a robust community engagement and research infrastructures were established to design a comprehensive obstetric sepsis bundle that i) applies and optimizes standard evidence-based components of readiness, recognition, response, reporting, and respectful care ii) incorporates multidisciplinary obstetric provider training, and iii) integrates screening for unmet needs.

In Aim 1b, the investigators will assess participant outcomes pre- and post-maternal sepsis bundle implementation. Participants will be followed through their hospitalization until delivery hospitalization discharge or development of sepsis and readmissions pertinent to the study will be assessed. For the pre-implementation cohort, the investigators will use electronic health record (EHR) data from delivery hospitalizations to women from 2020-2022 from the four partner NYC hospitals compared to deliveries post-implementation (2025)during award period.

In the UH3 phase, the investigators will engage the community to implement the maternal sepsis care model, analyze results, and translate findings. Aim 1b. Implement the comprehensive obstetric sepsis bundle and evaluate its effectiveness using process and outcome measures Aim 1c. Define patterns in EHR of provider response to suspected sepsis, pre- vs post-bundle implementation; analyze associations between provider response variation and outcomes.

Study Type

Interventional

Enrollment (Estimated)

33183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia Unviersity Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Dena Goffman, MD
      • New York, New York, United States, 10034
      • New York, New York, United States, 10037
        • Recruiting
        • NYC Health+Hospitals/Harlem
        • Contact:
      • The Bronx, New York, United States, 10451

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients Admitted for Delivery (Comparing Pre vs Post-Implementation)
Patients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures post-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations.
Behavioral: Maternal Sepsis Safety Bundle
Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Diagnosed with Maternal Sepsis
Time Frame: Delivery Admission
The number of patients diagnosed with maternal sepsis pre- and post- material sepsis bundle implementation. Sepsis as evaluated by the following scoring systems: Sepsis-2 (proven or suspected infection in combination with at least two systemic inflammatory response syndrome criteria); Sepsis-3 (organ dysfunction as defined by an acute change in total organ dysfunction score within 24 hours of suspected infection); and Center for Disease Control (CDC) Sepsis (presumed infection and organ dysfunction based on CDC criteria).
Delivery Admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Northern Manhattan Perinatal Partnership

Investigators

  • Principal Investigator: Dena Goffman, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

September 20, 2026

Study Registration Dates

First Submitted

November 17, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU3697 - Aim 1
  • 1UG3HD111247 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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