EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

Sponsor

Columbia University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06148532

Collaborator

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

400,000

Enrollment

Location

41.2

Anticipated Duration (Months)

9716.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Sepsis Infections

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

400000 participants

Observational Model:

Ecologic or Community

Time Perspective:

Retrospective

Official Title:

EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Actual Study Start Date :

Apr 26, 2023

Anticipated Primary Completion Date :

Aug 31, 2025

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

Maternal sepsis risk [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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