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Exploring the construction of a system for early identification and assessment of maternal sepsis based on pathogen and immune characteristics

Exploring the construction of a system for early identification and assessment of maternal sepsis based on pathogen and immune characteristics

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097049
Enrollment
Unknown
Registered
2025-02-11
Start date
2025-02-14
Completion date
Unknown
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant or postpartum women aged =18 years

Interventions

Gold Standard:The 2016 European Society of Intensive Care Medicine and the American Society of Intensive Care Medicine published the sepsis 3.0 diagnostic criteria, which is a sequential organ failure
Index test:Blood gas analysis, complete blood count, total bilirubin, blood pressure, GCS score, blood creatinine

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for the sepsis group: ? Pregnant women or women in the puerperium, aged = 18 years; 1.? Meet the diagnostic criteria for sepsis 3.0 published by the European Society of Intensive Care Medicine and the American Society of Intensive Care Medicine in 2016, that is, a sequential organ failure assessment (SOFA) score = 2 in the presence of a clear focus of infection. 2. Inclusion criteria for the non-sepsis group: ? pregnant women or women in the puerperium, ? those who do not meet the 2016 European Society of Intensive Care Medicine and the American Society of Intensive Care Medicine's sepsis 3.0 diagnostic criteria (see above for diagnostic criteria);

Exclusion criteria

Exclusion criteria: 1.? Age < 18 years; 2.? Patients with a history of confirmed hematopoietic stem cell transplantation; 3.? Patients with a history of confirmed rheumatic immune system diseases who are still being treated; 4.? Patients who have given up treatment after entering the ICU.

Design outcomes

Primary

MeasureTime frame
Infection markers (CRP, PCT, IL-6, SAA);;anti-inflammatory factors (TNF- a, IFN- ?, IL-1 a, IL-1 ß, IL-6, IL-8, IL-10, IL-4, IL-1Ra);cytokines (TGF-ß );(Lymphocyte classification) Neutrophils, monocytes, DC cells, NK cells;PD-1;Accuracy;Sensitivity;Specificity;

Secondary

MeasureTime frame
Pathogen detection using polymerase chain reaction technology;Pathogen spectrum detection by mNGS;Immunoprofiling;

Countries

China

Contacts

Public ContactJialin Yang

The Third Affiliated Hospital of Guangzhou Medical University

windward_y@126.com+86 13512760778

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026