EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

NCT ID: NCT06160349

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2026-09-30

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.

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.

Conditions

Maternal Sepsis; Infections

Keywords

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

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: RETROSPECTIVE

Study Groups

Patient Interviews

Patients with risk factors for maternal sepsis interviewed about pregnancy, labor/delivery, and postpartum via Zoom.

No interventions assigned to this group

Community Stakeholders

Community stakeholders with professional and/or academic backgrounds relevant to maternal health who participate in focus group discussion.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northern Manhattan Perinatal Partnership

OTHER

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Uma Reddy

Professor of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uma Reddy, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia Unviersity Medical Center

New York, New York, United States

NYC Health+Hospitals/Harlem

New York, New York, United States

NYC Health + Hospitals/Lincoln

The Bronx, New York, United States

Countries

United States

Other Identifiers

1UG3HD111247

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAU3697 - Aim 3

Identifier Type: -

Identifier Source: org_study_id