An observational study in Maternal Sepsis and Infections, sponsored by Columbia University. Enrolling by invitation at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Columbia University · Observational
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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 is one of 2 that started in 2023, is one of 8 observational ones, and was the 32nd 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:
Columbia University · Sites in United States
Women only · Healthy volunteers
Johns Hopkins University · Sites in United States
Ages 14–55 · Women only · Healthy volunteers
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: 18 Years and older · female · no healthy volunteers.
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33 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400,000 is above the median of 300 across 15 observational 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:
This tab as a report to print or save as PDF → With an account.
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 optimize risk prediction accounting for the social determinants of health, and establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity.
Maternal sepsis is the second leading cause of maternal death, major cause of morbidity, and preventable in most cases. EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will (Aim 2) Develop algorithms to optimize prediction of sepsis around delivery and postpartum.
In the UG3 phase, robust community engagement and research infrastructures were established to: Aim 2a. Create a rich electronic health records (EHR) database from the Perinatal Research Consortium (PRC). Aim 2b. Collate neighborhood-level datasets characterizing social determinants of health (SDOH)
In the UH3 phase, the investigators will Aim 2c. Harmonize patient-level EHR and neighborhood-level SDOH datasets and use machine learning models to analyze the individual and joint contributions of patient and neighborhood factors to optimize sepsis risk prediction within the PRC sample.
Delivery admission records at PRC sites
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Exclusion Criteria:
EHR records for hospital delivery admissions and postpartum readmissions obtained from Perinatal Research Consortium (PRC) sites to be harmonized with SDoH data and analyze to optimize sepsis risk prediction.
Maternal sepsis risk
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 hospitalization through 8 weeks postpartum
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2023 to primary completion in Dec 2025, 31 months.
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No contact was published for this record. The registry link below has the sponsor’s details.
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