An observational study in Sepsis, Maternal Sepsis and Maternal Sepsis During Labor, sponsored by Cardiff University. Status unknown at 1 site in United Kingdom. Open to female participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-27.
Sponsored by Cardiff University · Observational
A prospective observational cohort study investigating physiological parameters vs biological markers of whole blood in septic and non-septic pregnant woman to predict systemic immune health
The altered physiology of pregnancy makes the signs and symptoms of sepsis less distinctive in the pregnant population. This can lead to both over treatment (with antibiotics) and late identification of sepsis. The progression of sepsis can be rapid in this population, resulting in severe morbidity and mortality. The mortality associated with sepsis in the general population is over 10%, while septic shock can increase this figure up to 30%. A study looking at maternal mortality due to sepsis recognised that the time from the onset of infection to death was less than 24 hours in 50% of patients. A review of the literature shows that half of the fatal cases of maternal sepsis could have been prevented with early detection of sepsis.
The unmet need is therefore a diagnostic bedside tool that can be performed on women identified as high risk via physiological parameters. The tool needs to be quick and easy to use whilst accurate at diagnosing sepsis.
Study Objectives
To evaluate the effectiveness of physiological parameters in predicting maternal sepsis.
To evaluate the effectiveness of alternative biomarkers in diagnosing maternal sepsis including a genomic sepsis-test.
Investigation of the systemic immune health of women undergoing an uncomplicated pregnancy and labour.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's planned enrollment of 330 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Cardiff University is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women attending University Hospital of Wales Cardiff for their pregnancy care
Pregnant with viable pregnancy confirmed on ultrasound at dating scan and over 18 years of age Able to provide informed consent (a translation service will be provided for women where English is not the first language);
Women recruited into Cohort B will have deferred consent taken to avoid interference with clinical care.
Exclusion Criteria:
A longitudinal observational study looking at the pregnancy journey of 200 women Bloods taken for sepsis biomarkers including a genomic sepsis-test throughout the pregnancy journey
Diagnostic Test: Blood test
A consecutive collection of data from 100 pregnant women with suspected sepsis Bloods taken for Sepsis Biomarkers including a genomic sepsis-test throughout the sepsis episode
Diagnostic Test: Blood test
Drop of blood for RNA and metabolic analysis
Positive predictive value of genomic sepsis-test biomarker in identifying participants with confirmed sepsis
New genomic sepsis-test biomarker tested to see if it compares to clinically known biomarkers in identifying sepsis
Time frame: 2 years
Plan to share: No
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Cardiff University