Recruiting

Maternal SepsisEnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 1)

Sponsor:

Columbia University

Code:

NCT06145724

Conditions

Maternal Sepsis

Infections

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Maternal Sepsis Safety Bundle

Study Details

Brief summary:

Sepsis is the second leading cause of maternal death in the U.S. Labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.

Conditions

Maternal Sepsis

Infections

Study ID

NCT06145724

Start date

Jun 1, 2025

Status verified date

Jan, 2026

Completion date

Sep 20, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Inclusion Criteria:

Birthing Person (EMR evaluation):

-Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025

Exclusion Criteria:

Birthing Person (EMR evaluation)

-Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2020-2025 timeframe

Study Design

Enrollment

33183 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Patients Admitted for Delivery (Comparing Pre vs Post-Implementation)

Patients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures post-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations.

Interventions

Maternal Sepsis Safety Bundle

Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.

Primary outcome measure

Number of Participants Diagnosed with Maternal Sepsis [ Time Frame: Delivery Admission ]

Central Contacts and Locations

Central contacts

Briana Richardson, MPH

347-899-0486 br2724@cumc.columbia.edu

Locations

Columbia Unviersity Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Briana Richardson, MPH

347-899-0486 br2724@cumc.columbia.edu

Principal Investigator:

Dena Goffman, MD

NewYork-Presbyterian Allen Hospital

Recruiting

New York, New York, United States, 10034

Contacts

Donald Phillibert, MD

dp3125@cumc.columbia.edu

NYC Health+Hospitals/Harlem

Recruiting

New York, New York, United States, 10037

Contacts

Debra Taubel, MD

taubeld@nychhc.org

NYC Health + Hospitals/Lincoln

Recruiting

The Bronx, New York, United States, 10451

Contacts

Ruchi Upadhyay, MD

Ruchi.Upadhyay@nychhc.org

More Information

Sponsor

Columbia University

Last update posted

Jan 21, 2026

Last verified

Jan, 2026

Keywords

Post Partum Period
Pregnancy
Maternal Health
Electronic Health Record

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-01-21.