跳至主要内容
临床试验/EUCTR2016-000424-25-FR
EUCTR2016-000424-25-FR进行中(未招募)1 期

ow-molecular-weight heparin in constituted vascular intrauterine growth restriction. Randomized multicenter trial - GROWTH

CHU Saint-Etienne0 个研究点目标入组 162 人开始时间: 2019年2月8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
162

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

  • Patient over 18 years at > 22 and 34 weeks of gestation (WG) with vascular IUGR defined by :
  • - estimated fœtal weight below the 10th percentile
  • - clinical and ultrasound findings suggesting pathologically impaired growth or diminished fœtal well-being
  • - clinical and ultrasound findings suggesting placental insufficiency
  • Precise dating of pregnancy by ultrasound between 11 WG and 13 WE +6days
  • Written informed consent
  • 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 162
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Multiple pregnancy or identified cause of IUGR other than vascular
  • - Patient with an immediate indication for fœtal extraction
  • - Women with a history of venous thromboembolism or already treated with an anticoagulant
  • - Women with contraindication to enoxaparin treatment at prophylactic doses
  • Patient refusing to participate or unable to consent
  • Platelet count < 80,00 platelets/mm3 at the initial assessment
  • Patient denying self injection

研究者

发起方
CHU Saint-Etienne

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