Maternal Sepsis Safety Bundle for Pregnancy Complications

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byUma Reddy, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Trial Summary

What is the purpose of this trial?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 study is to evaluate a maternal sepsis safety bundle.

Eligibility Criteria

This trial is for English or Spanish-speaking individuals aged 18 or older who are clinicians, staff, or birthing persons at New York Presbyterian Morgan Stanley Children's Hospital, NYP Allen, Harlem Hospital, and Lincoln Hospital. It focuses on those with delivery hospitalizations and postpartum readmissions between 2021-2025.

Inclusion Criteria

I speak English or Spanish.

I am 18 years old or older.

Clinicians or staff at the 4 hospital sites: New York Presbyterian (NYP) Morgan Stanley Children's Hospital (MSCH) of New York at Columbia University, NYP Allen, Harlem Hospital, Lincoln Hospital

+1 more

Participant Groups

The study evaluates a maternal sepsis safety bundle designed to reduce the risk of sepsis during labor and postpartum periods. This is particularly aimed at helping racial and ethnic minoritized communities who face higher risks.

3Treatment groups

Experimental Treatment

Active Control

Group I: Patients Admitted for Delivery (Post-Implementation)Experimental Treatment1 Intervention

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.

Group II: Hospital StakeholdersActive Control1 Intervention

Hospital stakeholders at the partnering hospitals who participate in 90 min focus group discussion about maternal sepsis bundle implementation.

Group III: Patients Admitted for Delivery (Pre-implementation)Active Control1 Intervention

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 pre-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations from 2021-2022.