EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 2)

NCT06148532 | Enrolling By Invitation

• 2 other identifiers: AAAU3697 - Aim 21UG3HD111247
• Study Type: observational
• Target: 400,000
• Locations: 1 country
• Sites: 1

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 observational study is to optimize risk prediction accounting for the social determinants of health, and establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.

Conditions

Maternal Sepsis; Infections

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Maternal sepsis risk

  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 hospitalization through 8 weeks postpartum

Study Arms (1)

PRC Database

EHR records for hospital delivery admissions and postpartum readmissions obtained from Perinatal Research Consortium (PRC) sites to be harmonized with SDoH data and analyze to optimize sepsis risk prediction.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Delivery admission records at PRC sites

You may qualify if:

• Be 18 years or older
• Delivery admission (and) postpartum readmission at one of the Perinatal Research Consortium sites 2014-2021

You may not qualify if:

• Under 18 years old
• Delivery admission (and) postpartum readmission at hospital that is not in the Perinatal Research Consortium
• Delivery admission before 2014 or after 2021

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 (1)

Columbia Unviersity Medical Center

New York, New York, 10032, United States

Location

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

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• 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 20, 2023
• First Posted: November 28, 2023
• Study Start: April 26, 2023
• Primary Completion: December 9, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)