EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06145724
• Other study ID #: AAAU3697 - Aim 1
• Secondary ID: 1UG3HD111247
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: September 30, 2026

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 24040
• Est. completion date: September 30, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Pregnancy Complications, Infectious
• Sepsis
• Toxemia

Intervention

Behavioral:
• Maternal Sepsis Safety Bundle
Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Northern Manhattan Perinatal Partnership

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Post-partum, Up to 8 Weeks