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Behavioral Intervention

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Diagnosed with Maternal Sepsis

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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,423,769 Total Patients Enrolled

19 Trials studying Infections

440,747 Patients Enrolled for Infections

Northern Manhattan Perinatal PartnershipUNKNOWN

2 Previous Clinical Trials

400,200 Total Patients Enrolled

2 Trials studying Infections

400,200 Patients Enrolled for Infections

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

1,967 Previous Clinical Trials

2,648,857 Total Patients Enrolled

41 Trials studying Infections

447,676 Patients Enrolled for Infections

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participation in this research endeavor?

"According to clinicaltrials.gov, this particular study is not allowing any new participants at present. Initially posted on February 1st 2024, the trial was last edited on November 17th 2023 and has since been closed off for further recruitment. However, there are 967 other medical trials which are actively enrolling patients right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Uma Reddy 2024. "EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06145724.

All > Sepsis