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Enrolling by Invitation

NCT Number: NCT06160349

EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 3)

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Columbia Unviersity Medical Center, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient Interviews:

  • Speak Spanish or English
  • Be 18 years or older
  • Have a birthing experience in Columbia, Allen, Lincoln, or Harlem Hospitals within the past 8 weeks of enrollment
  • Have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum

Community Stakeholder Focus Groups:

  • Speak English or Spanish
  • Be 18 years or older
  • Have academic/professional background relevant to maternal health in New York City.

Exclusion criteria

Patient Interviews

  • Under 18 years old
  • Speaks a language other than Spanish or English
  • Gave birth in a hospital other than Columbia, Allen, Lincoln, or Harlem Hospitals
  • Did not have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum

Community Stakeholder Focus Groups

  • Under 18 years old
  • Speaks a language other than Spanish or English
  • Does not have a academic/professional background relevant to maternal health in New York City.

Treatment and study plan

Primary outcomes

  1. Integrative Supportive Care Model

    Time frame: 2023-2025

    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.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Northern Manhattan Perinatal Partnership

Registry information

Official study title

EnCoRe MoMS Aim 3: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 7, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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