An interventional study of Maternal Sepsis Safety Bundle in Maternal Sepsis and Infections, sponsored by Columbia University. Recruiting at 4 sites in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Columbia University · Not applicable, Interventional, and Prevention
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Among 33 studies in Pregnancy Complications, Infectious with a site in United States — 4 open to participants now, 5 under way, none of them phase 3. Pregnancy Complications, Infectious · United States.
Among the 33 studies in Pregnancy Complications, Infectious with a site in United States, this one has the largest planned enrollment of the 25 interventional ones that give a count, is the only one that started in 2025, is one of 2 with no phase, and was the 31st registered.
49 studies on the registry are indexed under Pregnancy Complications, Infectious; 7 are open to participants now.
Browse Pregnancy Complications, Infectious studies →4 of the 33 studies in Pregnancy Complications, Infectious with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 14–55 · Women only · Healthy volunteers
Columbia University · Sites in United States
Ages 18+ · Women only
Columbia University · Sites in United States
Ages 18+ · Women only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 3 Pregnancy Complications, Infectious studies recruiting now, 1 sets no upper age limit and 2 stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.
This study: female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
33 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 33,183 is above the median of 75 across 33 interventional studies indexed under Pregnancy Complications, Infectious.
Median enrollment 49 across the 25 interventional studies, 275 across the 8 observational. Of the 28 that completed or were terminated, 0 (0%) have results posted.
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None of the 33 has an industry lead sponsor. The 7 most frequent:
Columbia University is the lead sponsor of 1,136 studies on the registry; 195 are open to participants now.
Of its 181 completed or terminated interventional studies of FDA-regulated products, 149 (82%) have results posted.
Columbia University has 3 studies filed under Pregnancy Complications, Infectious — fewer than ten, so there is no comparison to draw.
1 of the studies in Pregnancy Complications, Infectious with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05197621Johns Hopkins UniversityThe Impact of COVID-19 on Maternal and Neonatal Outcomes | 2027-05-05 |
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Among the 33 studies in Pregnancy Complications, Infectious with a site in United States, from their registry updates:
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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.
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.
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Birthing Person (EMR evaluation):
-Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2020-2025
Exclusion Criteria:
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
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.
Behavioral: Maternal Sepsis Safety Bundle
Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.
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).
Time frame: Delivery Admission
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Aug 2026, 14 months after the start.
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