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

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06145724
Status
Recruiting

Conditions

  • Infections
  • Maternal Sepsis

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Maternal Sepsis Safety Bundle — BEHAVIORAL
    Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2026
Completion
Sep 20, 2026

Study Design

Enrollment
33,183 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Columbia Unviersity Irving Medical CenterNew YorkNew York10032
Briana Richardson, MPH
347-899-0486
Dena Goffman, MD (PRINCIPAL_INVESTIGATOR)
NewYork-Presbyterian Allen HospitalNew YorkNew York10034
Donald Phillibert, MD
NYC Health+Hospitals/HarlemNew YorkNew York10037
Debra Taubel, MD
NYC Health + Hospitals/LincolnThe BronxNew York10451
Ruchi Upadhyay, MD

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