EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Not Applicable

Not yet recruiting

• Conditions: Maternal Sepsis; Infections
• Interventions: Behavioral: Maternal Sepsis Safety Bundle

• Registration Number: NCT06145724
• Lead Sponsor: Columbia University

Brief Summary

Sepsis is the second leading cause of maternal death in the U.S. For racial and ethnic minoritized birthing people, especially those who are Black, living in poverty, and from underserved communities, labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.

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, particularly for racial and ethnic minoritized birthing people. 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 diverse 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 implicit bias training, and iii) integrates social determinants of health (SDOH) training and screening.

In this study, 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 assesses. For the pre-implementation cohort, the investigators will use electronic health record (EHR) data from 16,000 delivery hospitalizations to women from 2021-2022 from the four partner NYC hospitals compared to 8,000 deliveries postimplementation during award period (for a total of 24,000 delivery hospitalizations at the four local hospitals).

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 Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Study Start: 2025-06-01
• Primary Completion: 2026-08-31
• Study Completion: 2026-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 24040

Inclusion Criteria

Hospital Stakeholder Focus Groups:

• Speak English or Spanish

• Be 18 years or older

• Clinicians or staff at the 4 hospital sites

  • New York Presbyterian (NYP) Morgan Stanley Children's Hospital (MSCH) of New York at Columbia University
  • NYP Allen
  • Harlem Hospital
  • Lincoln Hospital

Birthing Person (EMR evaluation):

-Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2021-2025

Exclusion Criteria

Hospital Stakeholder Interview:

• Under 18 years old
• Speaks a language other than Spanish or English
• Is not associated with one of the 4 hospital sites

Birthing Person (EMR evaluation)

-Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2021-2025 timeframe

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients Admitted for Delivery (Post-Implementation)	Maternal Sepsis Safety Bundle	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Diagnosed with Maternal Sepsis	Post-partum, Up to 8 Weeks	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).

Trial Locations

Locations (4)

NYC Health + Hospitals/Lincoln; 🇺🇸 Bronx, New York, United States

Columbia Unviersity Irving Medical Center; 🇺🇸 New York, New York, United States

NewYork-Presbyterian Allen Hospital; 🇺🇸 New York, New York, United States

NYC Health+Hospitals/Harlem; 🇺🇸 New York, New York, United States