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

NCT06160349 | Enrolling By Invitation

• 2 other identifiers: AAAU3697 - Aim 31UG3HD111247
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Maternal Sepsis; Infections

Keywords

Post Partum Period; Pregnancy; Maternal Health; Electronic Health Record

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Manhattan Perinatal Partnership: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Columbia University: lead

Study Sites (3)

Columbia Unviersity Medical Center

New York, New York, 10032, United States

Location

NYC Health+Hospitals/Harlem

New York, New York, 10037, United States

Location

NYC Health + Hospitals/Lincoln

The Bronx, New York, 10451, United States

Location

MeSH Terms

Conditions

Pregnancy Complications, Infectious; Infections

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Dena Goffman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology)

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: December 7, 2023
• Study Start: July 20, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)