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
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