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临床试验/NCT02631226
NCT02631226Unknown不适用

Multi-resistant Enterobacteriaceae Colonisation in Less Than 32 Weeks Pregnant Women Admitted in the Hospital: a Multicenter Study (EME Study).

Corporacion Parc Tauli1 个研究点 分布在 1 个国家目标入组 580 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
580
试验地点
1
主要终点
Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women

研究概览

简要总结

The purpose of this study is to determine the prevalence and risk factors for multi-resistant enterobacteriaceae colonization in less than 32 weeks pregnant women admitted to the hospital and its transmission to the newborn, in order to avoid neonatal intensive care unit spread and nosocomial outbreaks.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Less than 32 weeks pregnant woman
  • Admitted to the hospital

排除标准

  • Screening done after 48 hours of admission
  • When delivery occurs before screening is performed

结局指标

主要结局

Prevalence of multi-resistant enterobacteriaceae colonisation in less than 32 weeks pregnant women

时间窗: 18 months

次要结局

  • Incidence of multi-resistant enterobacteriaceae colonisation of pregnant women admitted to the hospital by preterm premature rupture of membranes (PPROM)(18 months)
  • Transmission rate from the colonized woman to the newborn(18 months)
  • Prevalence of multi-resistant enterobacteriaceae colonisation of African or Asian pregnant women(18 months)
  • Number of multi-resisitant enterobacteriacea sepsis in the Neonatal Unit(18 months)

研究者

发起方
Corporacion Parc Tauli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Victoria Aldecoa-Bilbao

Principal Investigator

Corporacion Parc Tauli

研究点 (1)

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