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

NCT ID: NCT06148532

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 400000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-26
• Study Completion Date: 2026-09-30

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.

Detailed Description

Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will (Aim 2) Develop algorithms to optimize prediction of sepsis around delivery and postpartum.

In the UG3 phase, robust community engagement and research infrastructures were established to: Aim 2a. Create a rich electronic health records (EHR) database from the Perinatal Research Consortium (PRC). Aim 2b. Collate neighborhood-level datasets characterizing social determinants of health (SDOH)

In the UH3 phase, the investigators will Aim 2c. Harmonize patient-level EHR and neighborhood-level SDOH datasets and use machine learning models to analyze the individual and joint contributions of patient and neighborhood factors to optimize sepsis risk prediction within the PRC sample.

Conditions

Maternal Sepsis; Infections

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northern Manhattan Perinatal Partnership

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Dena Goffman

Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dena Goffman, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia Unviersity Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

1UG3HD111247

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU3697 - Aim 2

Identifier Type: -

Identifier Source: org_study_id