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

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Maternal Sepsis Female Urogenital Diseases and Pregnancy Complications Infections Pregnancy Complications Pregnancy Complications, Infectious Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Columbia Unviersity Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Maternal sepsis risk

Time frame: Delivery hospitalization through 8 weeks postpartum

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).

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Northern Manhattan Perinatal Partnership

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Nov 28, 2023
Registry last updated: Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Enrolling by Invitation