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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Infections; Maternal Sepsis

Detailed 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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia Unviersity Medical Center
    • New York, New York, United States, 10037
      • NYC Health+Hospitals/Harlem
    • The Bronx, New York, United States, 10451
      • NYC Health + Hospitals/Lincoln

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Patient Interviews; Patients with risk factors for maternal sepsis interviewed about pregnancy, labor/delivery, and postpartum via Zoom.
Community Stakeholders; Community stakeholders with professional and/or academic backgrounds relevant to maternal health who participate in focus group discussion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2023-2025

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Northern Manhattan Perinatal Partnership
• Investigators: Principal Investigator: Dena Goffman, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: November 28, 2023
• First Posted (Actual): December 7, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Maternal Health; Electronic Health Record; Post Partum Period
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Infections; Pregnancy Complications, Infectious
• Other Study ID Numbers: AAAU3697 - Aim 3; 1UG3HD111247 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No