Maternal Sepsis Safety Bundle for Pregnancy Complications

Recruiting at 4 trial locations

Overseen By Uma Reddy, MD

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Under 18, Non-English/Spanish, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

33183 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new safety bundle, the Maternal Sepsis Safety Bundle, to prevent sepsis—a life-threatening infection—during and after childbirth. The focus is on reducing deaths related to sepsis, a major risk during labor and the postpartum period. The study compares outcomes before and after implementing this safety bundle in several hospitals. It is best suited for individuals who gave birth or were readmitted postpartum at one of the participating hospitals between 2020 and 2025. As an unphased trial, this study offers a unique opportunity to contribute to improving maternal health care practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this maternal sepsis safety bundle is safe for pregnancy complications?

Research has shown that the Maternal Sepsis Safety Bundle reduces risks for pregnant women by detecting sepsis early. Sepsis is a serious condition where the body's reaction to an infection harms its own tissues. Early treatment is crucial to prevent organ damage and other severe outcomes.

The bundle includes steps to quickly identify, treat, and manage sepsis. Although specific safety data from studies are not available, the bundle aims to improve safety by speeding up care. This approach follows expert guidelines and has improved patient outcomes in similar situations.

This trial is not in a phase that typically provides detailed safety data. However, the bundle's design suggests it should be well-tolerated. It builds on practices already used in many hospitals, aiming to enhance current care for better safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Maternal Sepsis Safety Bundle because it aims to enhance the standard care for preventing sepsis during pregnancy by implementing a comprehensive protocol. Unlike traditional treatments that focus primarily on treating sepsis after it occurs, this safety bundle proactively addresses potential complications by integrating multiple preventative measures. This approach includes early identification of risks, standardized emergency response protocols, and coordinated care across hospital departments, which could lead to improved maternal and neonatal outcomes. By focusing on prevention and streamlined care, the bundle has the potential to significantly reduce sepsis-related complications and mortality rates in pregnant patients.

What evidence suggests that the Maternal Sepsis Safety Bundle is effective for pregnancy complications?

Research shows that the Maternal Sepsis Safety Bundle can improve outcomes for pregnant women by detecting and treating sepsis early. Sepsis is a serious condition where an infection causes organs to malfunction. Studies have found that this bundle helps hospitals identify and treat sepsis more quickly. This approach has been linked to better survival rates and fewer complications for mothers. In this trial, researchers will implement and evaluate the safety bundle by comparing outcomes for patients admitted for delivery before and after its implementation. The safety bundle emphasizes systems to recognize, treat, and provide additional care for sepsis in pregnant women. ^{1 2 3 5 6}

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

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

Birthing Person (EMR evaluation): Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2021-2025

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-implementation

Evaluation of process and outcome measures using EHR data from delivery hospitalizations pre-maternal sepsis bundle implementation

2021-2022

Implementation

Implementation of the comprehensive obstetric sepsis bundle and evaluation of its effectiveness

During award period

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 8 weeks post-partum

What Are the Treatments Tested in This Trial?

Interventions

• Maternal Sepsis Safety Bundle

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients Admitted for Delivery (Comparing Pre vs Post-Implementation) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Northern Manhattan Perinatal Partnership

Collaborator

Trials

4

Recruited

425,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Northern Manhattan Perinatal Partnership

Collaborator

Published Research Related to This Trial

The National Partnership for Maternal Safety has developed a safety bundle aimed at reducing the high rates of primary cesarean births, which have become a significant public health concern.

This safety bundle includes four key domains—Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning—providing a structured approach for maternity units to implement evidence-based practices and improve maternal safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Safe Reduction of Primary Cesarean Births-Supporting Intended Vaginal Births. Lagrew, DC., Kane Low, L., Brennan, R., et al.[2019]

The National Partnership for Maternal Safety has created a safety bundle aimed at reducing the high rates of primary cesarean births, which have become a significant public health concern.

This safety bundle includes critical practices organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for adaptation to individual facilities while promoting standardization within institutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Safe Reduction of Primary Cesarean Births-Supporting Intended Vaginal Births. Lagrew, DC., Low, LK., Brennan, R., et al.[2019]

The National Partnership for Maternal Safety has developed a safety bundle aimed at reducing the high rates of primary cesarean births, which have become a significant public health concern.

This safety bundle includes critical practices organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning, allowing for adaptation to individual facilities while promoting standardization within institutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Safe Reduction of Primary Cesarean Births- Supporting Intended Vaginal Births. Lagrew, DC., Low, LK., Brennan, R., et al.[2019]

Citations

1. saferbirth.org saferbirth.org/psbs/sepsis-in-obstetric-care/

Sepsis in Obstetric Care | AIM Sepsis in obstetric care refers to the World Health Organization definition for maternal sepsis as a life-threatening condition defined as organ dysfunction.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10424822/

Alliance for Innovation on Maternal Health The goal of the “Sepsis in Obstetric Care” patient safety bundle is to have systems in place to identify, treat, escalate care, and mitigate ...

3. withpower.com withpower.com/trial/phase-sepsis-2024-fd9b6

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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12506227/

Effectiveness and evidence-based practices in maternal ... Outcomes included studies reporting on maternal outcomes bundle effectiveness. Figure 1 (online supplemental file 1) includes the PICO ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146000524001137

Disparities in obstetric sepsis and strategies to prevent them Sepsis is a leading cause of SMM, accounting for 8 % to 12 % of intensive care unit (ICU) admissions among obstetric patients, with a high case fatality rate.1 ...

6. ihi.org ihi.org/sites/default/files/2024-04/AIM-Patient-Safety-Bundles_Change-Package_Sepsis-in-Obstetric-Care.pdf

Sepsis in Obstetric Care Change Package Maternal Safety Bundle for Sepsis in Pregnancy. Safe Motherhood Initative. American College of Obstetricians and. Gynecologists. Accessed February 22, 2023 ...