EnCoRe MoMS Aim 2: Engaging Communities to Reduce Morbidity From Maternal Sepsis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400,000
- 试验地点
- 1
- 主要终点
- Maternal sepsis risk
研究概览
简要总结
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 observational study is to optimize risk prediction accounting for the social determinants of health, and establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.
详细描述
Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will (Aim 2) Develop algorithms to optimize prediction of sepsis around delivery and postpartum.
In the UG3 phase, robust community engagement and research infrastructures were established to: Aim 2a. Create a rich electronic health records (EHR) database from the Perinatal Research Consortium (PRC). Aim 2b. Collate neighborhood-level datasets characterizing social determinants of health (SDOH)
In the UH3 phase, the investigators will Aim 2c. Harmonize patient-level EHR and neighborhood-level SDOH datasets and use machine learning models to analyze the individual and joint contributions of patient and neighborhood factors to optimize sepsis risk prediction within the PRC sample.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Be 18 years or older
- •Delivery admission (and) postpartum readmission at one of the Perinatal Research Consortium sites 2014-2021
排除标准
- •Under 18 years old
- •Delivery admission (and) postpartum readmission at hospital that is not in the Perinatal Research Consortium
- •Delivery admission before 2014 or after 2021
结局指标
主要结局
Maternal sepsis risk
时间窗: Delivery hospitalization through 8 weeks postpartum
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
Dena Goffman
Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology)
Columbia University