mSEP: Investigation of Maternal Immunity and Testing of Physiological and Immune-metabolic Blood Markers for Maternal Sepsis
试验速览
- 阶段
- 不适用
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Positive predictive value of genomic sepsis-test biomarker in identifying participants with confirmed sepsis
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Pregnant woman under the age of 18 or wishing not to consent, withdrawing consent or lacking capacity.
结局指标
主要结局
Positive predictive value of genomic sepsis-test biomarker in identifying participants with confirmed sepsis
时间窗: 2 years
New genomic sepsis-test biomarker tested to see if it compares to clinically known biomarkers in identifying sepsis
次要结局
未报告次要终点