EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

Status Enrolling by invitation

Clinical Trial Summary

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 establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.

Clinical Trial Description

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, particularly for racial and ethnic minoritized birthing people. With extensive community partnerships and community organized leadership advisory board (CoLAB), EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis (Aim 3) Conduct a co-design process and qualitative study to explore the experiences, needs, and perceived solutions for maternal care continuity, sepsis prevention, and promotion of equity in postpartum. In the UG3 phase, robust community engagement and research infrastructures were established to: 3a. (3a.1) Refine the CoLAB and co-design process; (3a.2) Conduct in-depth individual patient interviews (IDIs) and focus group discussions (FGDs) with community and hospital stakeholders from one site to explore the lived experiences and perspectives of SDOH on care access/quality, outcome disparities, and solutions for care continuity. In the UH3 phase, the investigators will engage the community toAim 3b. (3b.1) Complete qualitative patient IDIs and stakeholder FGDs for the three additional hospital sites; (3b.2) Co-design an integrative supportive care model, with our community partner co-lead, CoLAB, and results from other aims, that entails maternal sepsis community engagement, care linkages, education, services, and policy efforts. The resulting model can be scaled to hospitals and communities with lesser resources and applied to other preventable causes of severe maternal morbidity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06160349
Study type	Observational
Source	Columbia University
Contact
Status	Enrolling by invitation
Phase
Start date	July 20, 2023
Completion date	September 30, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.