EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

Infections Clinical Trial

Official title:

EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06148532
• Other study ID #: AAAU3697 - Aim 2
• Secondary ID: 1UG3HD111247
• Status: Enrolling by invitation
• Start date: April 26, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 400000
• Est. completion date: September 30, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infections
• Pregnancy Complications, Infectious
• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	Columbia Unviersity Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Northern Manhattan Perinatal Partnership

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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