CClinicalTrials.gg
Enrolling by invitationNCT06160349Updated Jan 21, 2026

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

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

Study type
Observational
Model
Ecologic or community
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Maternal Sepsis
  • Infections

Keywords

  • Post Partum Period
  • Pregnancy
  • Maternal Health
  • Electronic Health Record
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
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

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

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.
04

Study design

Observational model
Ecologic or community
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

05

What researchers measure

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.

    Time frame: 2023-2025

06

Study locations

3 sites
  • Columbia Unviersity Medical Center
    New York, New York 10032, United States
  • NYC Health+Hospitals/Harlem
    New York, New York 10037, United States
  • NYC Health + Hospitals/Lincoln
    The Bronx, New York 10451, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06160349
Lead sponsor
Columbia University
Collaborators
Northern Manhattan Perinatal Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Responsible party
Dena Goffman (Ellen Jacobson Levine and Eugene Jacobson Professor of Women's Health (in Obstetrics and Gynecology), Columbia University) — Principal investigator
First posted
Dec 7, 2023
Start date
Jul 20, 2023
Primary completion
Aug 31, 2026 (estimated)
Completion
Sep 30, 2026 (estimated)
Last update
Jan 21, 2026

Study contacts

Dena Goffman, MD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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