Maternal Sepsis Safety Bundle for Pregnancy Complications
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is the Maternal Sepsis Safety Bundle safe for use in humans?
The Maternal Sepsis Safety Bundle is designed to improve care for pregnant and postpartum people by preventing and treating infections early, which can help prevent sepsis. It is part of a set of safety practices developed to ensure coordinated and supportive care, and while specific safety data isn't detailed, these bundles are generally created to enhance safety in healthcare settings.12345
How is the Maternal Sepsis Safety Bundle treatment different from other treatments for maternal sepsis?
The Maternal Sepsis Safety Bundle is unique because it provides a structured approach specifically for pregnant and postpartum patients, focusing on early recognition and prevention of sepsis through coordinated care. Unlike other treatments, it includes domains like Readiness, Recognition and Prevention, Response, Reporting and Systems Learning, and Respectful, Equitable, and Supportive Care, ensuring comprehensive and equitable care for all patients.14567
What data supports the effectiveness of the treatment Maternal Sepsis Safety Bundle for pregnancy complications?
The Maternal Sepsis Safety Bundle is designed to improve outcomes by ensuring early recognition and treatment of sepsis in pregnant women, which is crucial as sepsis is a leading cause of maternal death. Studies show that using a standardized approach, like a sepsis bundle, improves compliance with treatment protocols and can lead to better health outcomes.46789
Who Is on the Research Team?
Uma Reddy, MD
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-implementation
Evaluation of process and outcome measures using EHR data from delivery hospitalizations pre-maternal sepsis bundle implementation
Implementation
Implementation of the comprehensive obstetric sepsis bundle and evaluation of its effectiveness
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Maternal Sepsis Safety Bundle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Northern Manhattan Perinatal Partnership
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Northern Manhattan Perinatal Partnership
Collaborator