An observational study in Maternal Sepsis and Infections, sponsored by Columbia University. Enrolling by invitation at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Columbia University · Observational
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.
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.
For patient interviews- Adult women have a birthing experience in Columbia, Allen, Lincoln, or Harlem Hospitals within the past 8 weeks of enrollment
For focus groups- stakeholders with academic/professional backgrounds relevant to maternal health
Patient Interviews:
Community Stakeholder Focus Groups:
Exclusion Criteria:
Patient Interviews
Community Stakeholder Focus Groups
Patients with risk factors for maternal sepsis interviewed about pregnancy, labor/delivery, and postpartum via Zoom.
Community stakeholders with professional and/or academic backgrounds relevant to maternal health who participate in focus group discussion.
Integrative Supportive Care Model
Patient and community stakeholder feedback regarding lived experiences and perspectives of the impact of SDOH on care access and quality will be assessed by questionnaire.
Time frame: 2023-2025
Plan to share: No
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Pregnancy Complications, Infectious→
Columbia University