跳至主要内容
临床试验/NCT06145724
NCT06145724招募中不适用

EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle

Columbia University8 个研究点 分布在 1 个国家目标入组 33,183 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
33,183
试验地点
8
主要终点
Number of Participants Diagnosed with Maternal Sepsis

研究概览

简要总结

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.

详细描述

Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. Labor, birth, and postpartum are periods of increased sepsis risk. While American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend the implementation of safety bundles to prevent maternal mortality as the standard of care, there is limited evidence regarding effectiveness. EnCoRe MoMS will directly evaluate safety bundle performance for maternal sepsis. With extensive community partnerships and community organized leadership advisory board (CoLAB), EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will develop, implement, and evaluate a community-informed maternal sepsis bundle in 4 New York City (NYC) hospitals.

In Aim 1a: a robust community engagement and research infrastructures were established to design a comprehensive obstetric sepsis bundle that i) applies and optimizes standard evidence-based components of readiness, recognition, response, reporting, and respectful care ii) incorporates multidisciplinary obstetric provider training, and iii) integrates screening for unmet needs.

In Aim 1b, the investigators will assess participant outcomes pre- and post-maternal sepsis bundle implementation. Participants will be followed through their hospitalization until delivery hospitalization discharge or development of sepsis and readmissions pertinent to the study will be assessed. For the pre-implementation cohort, the investigators will use electronic health record (EHR) data from delivery hospitalizations to women from 2020-2022 from the four partner NYC hospitals compared to deliveries post-implementation (2025)during award period.

In the UH3 phase, the investigators will engage the community to implement the maternal sepsis care model, analyze results, and translate findings. Aim 1b. Implement the comprehensive obstetric sepsis bundle and evaluate its effectiveness using process and outcome measures Aim 1c. Define patterns in EHR of provider response to suspected sepsis, pre- vs post-bundle implementation; analyze associations between provider response variation and outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • Birthing Person (EMR evaluation):
  • Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025

排除标准

  • Birthing Person (EMR evaluation)
  • Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2020-2025 timeframe

结局指标

主要结局

Number of Participants Diagnosed with Maternal Sepsis

时间窗: Delivery Admission

The number of patients diagnosed with maternal sepsis pre- and post- material sepsis bundle implementation. Sepsis as evaluated by the following scoring systems: Sepsis-2 (proven or suspected infection in combination with at least two systemic inflammatory response syndrome criteria); Sepsis-3 (organ dysfunction as defined by an acute change in total organ dysfunction score within 24 hours of suspected infection); and Center for Disease Control (CDC) Sepsis (presumed infection and organ dysfunction based on CDC criteria).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dena Goffman

Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology)

Columbia University

研究点 (8)

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