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24040 Participants Needed

Maternal Sepsis Safety Bundle for Pregnancy Complications

Recruiting at 3 trial locations

Overseen ByUma Reddy, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Columbia University

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

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

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.

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 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.¹ ² ³ ⁴ ⁵

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.¹ ⁶ ⁷ ⁸ ⁹

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.¹ ² ³ ⁶ ⁹

Research Team

Uma Reddy, MD

Principal Investigator

Columbia University

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

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Timeline

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

Treatment Details

Interventions

Maternal Sepsis Safety Bundle

Trial OverviewThe 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.

Participant Groups

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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Northern Manhattan Perinatal Partnership

Collaborator

Trials

Recruited

425,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Findings from Research

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.

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 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]