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

NCT06145724 | Recruiting

• 2 other identifiers: AAAU3697 - Aim 11UG3HD111247
• Study Type: interventional
• Target: 33,183
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Maternal Sepsis; Infections

Keywords

Post Partum Period; Pregnancy; Maternal Health; Electronic Health Record

Outcome Measures

Primary Outcomes (1)

• Number of Participants Diagnosed with Maternal Sepsis

  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

Study Arms (1)

Patients Admitted for Delivery (Comparing Pre vs Post-Implementation)

EXPERIMENTAL

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

Interventions

Maternal Sepsis Safety Bundle BEHAVIORAL

Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.

Patients Admitted for Delivery (Comparing Pre vs Post-Implementation)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Birthing Person (EMR evaluation):
• Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Northern Manhattan Perinatal Partnership: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Columbia Unviersity Irving Medical Center

New York, New York, 10032, United States

RECRUITING

NewYork-Presbyterian Allen Hospital

New York, New York, 10034, United States

RECRUITING

NYC Health+Hospitals/Harlem

New York, New York, 10037, United States

RECRUITING

NYC Health + Hospitals/Lincoln

The Bronx, New York, 10451, United States

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications, Infectious; Infections

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dena Goffman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Briana Richardson, MPH

CONTACT

347-899-0486; br2724@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology)

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: November 24, 2023
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 20, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)