CClinicalTrials.gg
Enrolling by invitationNCT06148532Updated Jan 21, 2026

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

An observational study in Maternal Sepsis and Infections, sponsored by Columbia University. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.

Sponsored by Columbia University · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
400,000
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Maternal Sepsis
  • Infections

Keywords

  • Electronic Health Record
  • Post Partum Period
  • Pregnancy
  • Maternal Health
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Delivery admission records at PRC sites

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
400,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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).

    Time frame: Delivery hospitalization through 8 weeks postpartum

06

Study locations

1 site
  • Columbia Unviersity Medical Center
    New York, New York 10032, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06148532
Lead sponsor
Columbia University
Collaborators
Northern Manhattan Perinatal Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Dena Goffman (Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology), Columbia University) — Principal investigator
First posted
Nov 28, 2023
Start date
Apr 26, 2023
Primary completion
Dec 9, 2025
Completion
Sep 30, 2026 (estimated)
Last update
Jan 21, 2026

Study contacts

Dena Goffman, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion