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临床试验/EUCTR2012-002068-29-DK
EUCTR2012-002068-29-DK进行中(未招募)1 期

Antibiotic Prophylaxis and Intervention for Postpartum Infections following Caesarean Section - The APIPICS study

Jan Stener Joergensen0 个研究点目标入组 2,844 人开始时间: 2014年1月13日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
2,844

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Female

入选标准

  • Sub-study 1:
  • - Age = 18 year
  • - Women, who can read and understand Danish
  • - A gestational age = completed 28 weeks of gestation
  • - Rupture of membranes and active labour (uterine contractions) is allowed
  • Sub-study 2:
  • - Age = 18 year
  • - Women, who can read and understand Danish
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 2844
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Sub-study 1:
  • - Hypersensitivity to cefuroxim or to any other cephalosporin antibiotics
  • - Previous immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic.
  • - Systemic exposure to any antibiotic agent within 1 week before delivery Antibiotic indicated due to PROM, fever, GBS or other indications at the time of caesarean section.
  • - Women being immunologically incompetent (e.g. HIV positive)
  • Sub-study 2:
  • - Serious illness requiring medical treatment, such as cancer
  • - Stillborn child
  • - If the fascia is ruptured

研究者

发起方
Jan Stener Joergensen

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