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 |
Phase |
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.