Evaluation of the Risk of Infection During Fever in Labor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 422
- 试验地点
- 3
- 主要终点
- Percentage of maternal-fetal infections
研究概览
简要总结
- Fever during labor affects more than 8% of parturients. It is a heterogeneous entity and can be due to an infectious process, a side effect of a drug, or to labor itself (physiological hyperthermia).
- It has been the subject of several retrospective studies and a few prospective studies with varying methodologies, definitions, and inclusion criteria. None have proposed a combined obstetric, neonatal, infectious disease, and microbiological analysis.
- It raises concerns about the possibility of an emerging maternal (obstetric or otherwise) and/or fetal infection.
- Analysis of the available literature does not clarify the exact frequency of these infections or the predictive factors for their occurrence.
- It often justifies systemic antibiotic therapy, the modalities and benefits of which have never been evaluated.
The investigators aim to conduct a prospective multicenter study to analyze fever during labor with a combined obstetric, infectious disease, pediatric, and microbiological perspective.
详细描述
The primary objective of this study is to analyze the causes of fever during labor by categorizing them into 3 etiological categories:
- Fever indicative of maternofetal infection: potentially early intrauterine infection leading to proven or probable early-onset neonatal bacterial infection, endometritis, or maternal sepsis.
- Fever indicative of maternal infectious pathology outside the obstetrical field (e.g., pyelonephritis, influenza, COVID, etc.).
- Fever of non-infectious origin.
Secondary objectives include:
- Describing the epidemiology and local ecology of bacterial infections.
- Identifying predictive factors for each category (obstetrical infection, non-obstetrical infection, and non-infectious fever) when fever occurs during labor.
- Evaluating the maternal and neonatal prognosis of mother-child pairs who do not receive antibiotic treatment according to local protocols (e.g., in cases of fever below a threshold value).
Depending on the results and sample size, the study will also attempt to evaluate the maternal and neonatal prognosis of mother-child pairs in cases where fever is attributed to maternofetal infectious causes (category 1) according to the antibiotic management strategy for fever during labor at each center.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women at least more than 37 weeks
- •Who have not opposed the collection of their health data for the purposes of studies and analyzes
- •In work between 07/01/2023 and 06/01/2024
- •Admitted to the work room at Port Royal, Necker Sick Children or Trousseau
- •With fever defined as a tympanic temperature > 38°C at least 2 times at 10 min intervals during labor.
排除标准
- •Pregnant women :
- •express their opposition to the collection of their data for research purposes
- •minors or under legal protection
- •context of medical termination of pregnancy or fetal death
结局指标
主要结局
Percentage of maternal-fetal infections
时间窗: Up to 6 months
intrauterine infection possibly responsible for early neonatal bacterial infection (proven or probable), endometritis, maternal sepsis
Percentage of proven maternal bacterial infections
时间窗: Up to 6 months
(non-obstetric, intrauterine, endometritis)
Percentage of proven and probable early neonatal infections
时间窗: Up to 6 months
次要结局
- Occurrence of serious accident III or IV linked to the prescription of antibiotics(Up to 6 months)
- Occurrence of maternal sepsis(Up to 6 months)
- occurrence of endometritis(Up to 6 months)
- occurrence of proven or probable early neonatal infection(Up to 6 months)
- Percentage of antibiotic therapy(Up to 6 months)