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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06145724
Enrollment
33183
Registered
2023-11-24
Start date
2025-06-01
Completion date
2026-09-20
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections, Maternal Sepsis

Keywords

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

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.

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.

Interventions

BEHAVIORALMaternal Sepsis Safety Bundle

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

Sponsors

Columbia University
Lead SponsorOTHER
Northern Manhattan Perinatal Partnership
CollaboratorOTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Diagnosed with Maternal SepsisDelivery AdmissionThe 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).

Countries

United States

Contacts

CONTACTBriana Richardson, MPH
br2724@cumc.columbia.edu347-899-0486
PRINCIPAL_INVESTIGATORDena Goffman, MD

Columbia University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026