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临床试验/NCT00920530
NCT00920530已完成不适用

Real-Time PCR for the Detection of Vaginal Group B Streptococcus Carriage at Delivery : a Medico-Economic and Feasibility Study

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2008年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
224
试验地点
1
主要终点
number of women receiving a useless antibiotic prevention

研究概览

简要总结

Group B streptococcus infections may be serious for the neonates. The infection can occur during the birth, by contact with the genital area. That is why the detection of this bacteria is systematically realised in pregnant women between 34 and 37 weeks of amenorrhea in order to give prophylactic antibiotic treatment in case or positive carriage. This strategy presents 2 disadvantages : (1) detection of the group B streptococcus at 34 and 37 weeks of amenorrhea in not predictive of a carriage at delivery, (2) many pregnant women escape from systematic screening, leading to a systematic antibiotic treatment, which means useless costs, and useless antibiotic exposure with resistant bacteria selection. Real time polymerase chain reaction (PCR) allows a rapid detection anytime with no specific microbiological qualification. The aim of the study is to assess the economic outcomes of this strategy and the epidemiological values for St Etienne hospital.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • women giving birth

排除标准

  • planned caesarian
  • cervical diameter > 5 cm
  • women giving birth at less than 35 weeks of amenorrhea
  • recent antibiotherapy

结局指标

主要结局

number of women receiving a useless antibiotic prevention

时间窗: 1 day

次要结局

  • epidemiological outcomes for group B streptococcus(1 day)
  • economic outcomes(1 day)
  • diagnosis efficacy of the real time PCR(1 day)

研究者

研究点 (1)

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