An observational study in Maternal Sepsis and Infections, sponsored by Columbia University. Enrolling by invitation at 3 sites 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
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
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.
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. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is below 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.
This tab as a report to print or save as PDF → With an account.
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 |
Add it to your calendar (.ics) → With an account.
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 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. 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.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient Interviews:
Community Stakeholder Focus Groups:
Exclusion Criteria:
Patient Interviews
Community Stakeholder Focus Groups
Patients with risk factors for maternal sepsis interviewed about pregnancy, labor/delivery, and postpartum via Zoom.
Community stakeholders with professional and/or academic backgrounds relevant to maternal health who participate in focus group discussion.
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.
Time frame: 2023-2025
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Aug 2026, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pregnancy Complications, Infectious →