EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis

Infections Clinical Trial

Official title:

EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06160349
• Other study ID #: AAAU3697 - Aim 3
• Secondary ID: 1UG3HD111247
• Status: Enrolling by invitation
• Start date: July 20, 2023
• Est. completion date: September 30, 2026

Study information

• Verified date: November 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: September 30, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Infections
• Pregnancy Complications, Infectious
• Sepsis
• Toxemia

Locations

Country	Name	City	State
United States	NYC Health + Hospitals/Lincoln	Bronx	New York
United States	Columbia Unviersity Medical Center	New York	New York
United States	NYC Health+Hospitals/Harlem	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Northern Manhattan Perinatal Partnership

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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