Maternal Sepsis Safety Bundle for Pregnancy Complications

N/A

Waitlist Available

Led By Uma Reddy, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospital Stakeholder Focus Groups: Be 18 years or older

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-partum, up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will research ways to reduce maternal sepsis deaths, which disproportionately affect Black, poor, and underserved birthing people.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves implementing a safety protocol rather than testing a new medication, traditional side effects are not applicable. However, there may be indirect impacts related to changes in clinical practice.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-partum, up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-partum, up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-partum, up to 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants Diagnosed with Maternal Sepsis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 1Eligibility criteria met