Maternal SepsisNCT06145724
EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 1)
A study testing Maternal Sepsis Safety Bundle in people with Maternal Sepsis and Infections, run by Columbia University at 4 sites in United States.
Trial summary
Sepsis is the second leading cause of maternal death in the U.S. Labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Sepsis, Infections
- What is being tested?
- Maternal Sepsis Safety Bundle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,183 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Jun 2025to 20 Sep 2026
- Phase
- Interventional
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Birthing Person (EMR evaluation):
- -Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025
Who cannot join
- Birthing Person (EMR evaluation)
- -Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2020-2025 timeframe
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Columbia Unviersity Irving Medical Center
New York, New York, 10032
Briana Richardson, MPH, 347-899-0486, br2724@cumc.columbia.edu
Dena Goffman, MD
- Recruiting
NewYork-Presbyterian Allen Hospital
New York, New York, 10034
Donald Phillibert, MD, dp3125@cumc.columbia.edu
- Recruiting
NYC Health+Hospitals/Harlem
New York, New York, 10037
Debra Taubel, MD, taubeld@nychhc.org
- Recruiting
NYC Health + Hospitals/Lincoln
The Bronx, New York, 10451
Ruchi Upadhyay, MD, Ruchi.Upadhyay@nychhc.org
About this study
Official title: EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle
Sepsis is the second leading cause of maternal death in the U.S. Labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.
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. While American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend the implementation of safety bundles to prevent maternal mortality as the standard of care, there is limited evidence regarding effectiveness. EnCoRe MoMS will directly evaluate safety bundle performance for maternal sepsis. With extensive community partnerships and community organized leadership advisory board (CoLAB), EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will develop, implement, and evaluate a community-informed maternal sepsis bundle in 4 New York City (NYC) hospitals.
In Aim 1a: a robust community engagement and research infrastructures were established to design a comprehensive obstetric sepsis bundle that i) applies and optimizes standard evidence-based components of readiness, recognition, response, reporting, and respectful care ii) incorporates multidisciplinary obstetric provider training, and iii) integrates screening for unmet needs.
In Aim 1b, the investigators will assess participant outcomes pre- and post-maternal sepsis bundle implementation. Participants will be followed through their hospitalization until delivery hospitalization discharge or development of sepsis and readmissions pertinent to the study will be assessed. For the pre-implementation cohort, the investigators will use electronic health record (EHR) data from delivery hospitalizations to women from 2020-2022 from the four partner NYC hospitals compared to deliveries post-implementation (2025)during award period.
In the UH3 phase, the investigators will engage the community to implement the maternal sepsis care model, analyze results, and translate findings. Aim 1b. Implement the comprehensive obstetric sepsis bundle and evaluate its effectiveness using process and outcome measures Aim 1c. Define patterns in EHR of provider response to suspected sepsis, pre- vs post-bundle implementation; analyze associations between provider response variation and outcomes.
- Conditions
- Maternal Sepsis, Infections
- Being tested
- Maternal Sepsis Safety Bundle
- 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.
Maternal Sepsis Safety BundleBehavioural
Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.
| Study group | Role | What they receive |
|---|---|---|
| Patients Admitted for Delivery (Comparing Pre vs Post-Implementation) | Experimental | Patients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures post-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations. Receives: Behavioral: Maternal Sepsis Safety Bundle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Diagnosed with Maternal Sepsis
The number of patients diagnosed with maternal sepsis pre- and post- material sepsis bundle implementation. Sepsis as evaluated by the following scoring systems: Sepsis-2 (proven or suspected infection in combination with at least two systemic inflammatory response syndrome criteria); Sepsis-3 (organ dysfunction as defined by an acute change in total organ dysfunction score within 24 hours of suspected infection); and Center for Disease Control (CDC) Sepsis (presumed infection and organ dysfunction based on CDC criteria).
Measured: Delivery Admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start1 Jun 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion20 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33,183 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
- NCT06145724
- Sponsor's protocol ID
- AAAU3697 - Aim 1
- Other IDs
- 1UG3HD111247
- Status last verified
- Jan 2026
- First submitted
- 17 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 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle
- ClinicalTrials.gov ID
- NCT06145724
- Acronym / sponsor ID
- AAAU3697 - Aim 1
- Conditions
- Maternal Sepsis, Infections
- Keywords
- Post Partum Period, Pregnancy, Maternal Health, Electronic Health Record
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33,183 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
- 1 Jun 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 24 Nov 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. Labor and postpartum are particularly vulnerable risk periods. The goal of this multi-center, multidisciplinary study is to evaluate a maternal sepsis safety bundle.
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. While American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend the implementation of safety bundles to prevent maternal mortality as the standard of care, there is limited evidence regarding effectiveness. EnCoRe MoMS will directly evaluate safety bundle performance for maternal sepsis. With extensive community partnerships and community organized leadership advisory board (CoLAB), EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will develop, implement, and evaluate a community-informed maternal sepsis bundle in 4 New York City (NYC) hospitals.
In Aim 1a: a robust community engagement and research infrastructures were established to design a comprehensive obstetric sepsis bundle that i) applies and optimizes standard evidence-based components of readiness, recognition, response, reporting, and respectful care ii) incorporates multidisciplinary obstetric provider training, and iii) integrates screening for unmet needs.
In Aim 1b, the investigators will assess participant outcomes pre- and post-maternal sepsis bundle implementation. Participants will be followed through their hospitalization until delivery hospitalization discharge or development of sepsis and readmissions pertinent to the study will be assessed. For the pre-implementation cohort, the investigators will use electronic health record (EHR) data from delivery hospitalizations to women from 2020-2022 from the four partner NYC hospitals compared to deliveries post-implementation (2025)during award period.
In the UH3 phase, the investigators will engage the community to implement the maternal sepsis care model, analyze results, and translate findings. Aim 1b. Implement the comprehensive obstetric sepsis bundle and evaluate its effectiveness using process and outcome measures Aim 1c. Define patterns in EHR of provider response to suspected sepsis, pre- vs post-bundle implementation; analyze associations between provider response variation and outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients Admitted for Delivery (Comparing Pre vs Post-Implementation) | Experimental | Behavioral: Maternal Sepsis Safety BundlePatients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures post-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- -Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025
Key exclusion criteria (2 listed)
- Birthing Person (EMR evaluation)
- -Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2020-2025 timeframe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Sepsis Safety BundleMaternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals. | Behavioural | Patients Admitted for Delivery (Comparing Pre vs Post-Implementation) |
Primary outcome
Number of Participants Diagnosed with Maternal Sepsis
Time frame: Delivery Admission
The number of patients diagnosed with maternal sepsis pre- and post- material sepsis bundle implementation. Sepsis as evaluated by the following scoring systems: Sepsis-2 (proven or suspected infection in combination with at least two systemic inflammatory response syndrome criteria); Sepsis-3 (organ dysfunction as defined by an acute change in total organ dysfunction score within 24 hours of suspected infection); and Center for Disease Control (CDC) Sepsis (presumed infection and organ dysfunction based on CDC criteria).
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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Sepsis Safety Bundle in people with Maternal Sepsis and Infections, run by Columbia University at 4 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 2 inclusion and 2 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: looking for participants now, 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 4 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?
Contact Briana Richardson, MPH (347-899-0486, br2724@cumc.columbia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Diagnosed with Maternal Sepsis (time frame: Delivery Admission). 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.