Maternal SepsisNCT06160349
EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 3)
An observational study of Maternal Sepsis and Infections, run by Columbia University at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Maternal Sepsis, Infections
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 20 Jul 2023to 30 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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:
Show all 9Show fewer
- Speak English or Spanish
- Be 18 years or older
- Have academic/professional background relevant to maternal health in New York City.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Columbia Unviersity Medical Center
New York, New York, 10032
NYC Health+Hospitals/Harlem
New York, New York, 10037
NYC Health + Hospitals/Lincoln
The Bronx, New York, 10451
About this study
Official title: EnCoRe MoMS Aim 3: Engaging Communities to Reduce Morbidity From Maternal Sepsis
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.
- Conditions
- Maternal Sepsis, Infections
- Keywords
- Post Partum Period, Pregnancy, Maternal Health, Electronic Health Record
- Medical subject headings
- Pregnancy Complications, Infectious, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2023-2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start20 Jul 2023
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal SepsisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Manhattan Perinatal Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Dena Goffman, Columbia University
- Investigators
- Dena Goffman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160349
- Sponsor's protocol ID
- AAAU3697 - Aim 3
- Other IDs
- 1UG3HD111247
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EnCoRe MoMS Aim 3: Engaging Communities to Reduce Morbidity From Maternal Sepsis
- ClinicalTrials.gov ID
- NCT06160349
- Acronym / sponsor ID
- AAAU3697 - Aim 3
- Conditions
- Maternal Sepsis, Infections
- Keywords
- Post Partum Period, Pregnancy, Maternal Health, Electronic Health Record
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Northern Manhattan Perinatal Partnership, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- 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
- Speak English or Spanish
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Integrative Supportive Care Model
Time frame: 2023-2025
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dena Goffman, MD principal investigator
Columbia University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Maternal Sepsis and Infections, run by Columbia University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Integrative Supportive Care Model (time frame: 2023-2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.