EUCTR2006-001984-53-DE进行中（未招募）不适用
Effectiveness of Dalteparin Therapy as Intervention in recurrent pregnancy loss - EHTIG II
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 486
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
- •Patients must meet ALL of the following criteria:
- •Single pregnancy, 5th to 8th week of gestation
- •Documented foetal heart activity in US
- •History of recurrent pregnancy loss, defined as:
- •-2 or more early (< 12 weeks of gestation) pregnancy losses or
- •-1 or more late (> 12 weeks of gestation) pregnancy loss
- •Age > 18 years
- •Written informed consent of the patient
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded for ANY ONE of the following reasons:
- •Previous pregnancy losses caused by foetal structural or chromosomal anomalies
- •Uterine anomalies
- •Maternal infection which caused previous pregnancy loss
- •Risk group II or III according to ETHIG I risk stratification (clinical need for heparin prophylaxis)
- •Acute thromboembolic event (need of heparin therapy)
- •Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin)
- •Antiphospholipid antibody syndrome
- •Diabetes mellitus
- •Ongoing nicotine or drug or alcohol abuse
- •HIV positive
- •Expected low compliance (e.g. by travel distance to trial site)
- •Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
- •Injuries or surgeries of CNS, eyes or ear during the last 8 weeks prior to randomisation
- •Active clinical significant bleeding (e.g. gastrointestinal, intracranial, intraocular) during the last 3 months prior to randomisation
- •Diseases associated with enhanced predisposition of bleeding (e.g. hemorrhagic diathesis, deficiency of coagulation factors, severe affection of liver, kidney or pancreas, severe thrombocytopenia)
- •Diseases caused by lesions of the vascular system (e.g. gastric, peptic or intestinal ulcer, hypertension (RR diast. > 105 mmHg, hemorrhagic apoplectic insult (3 month prior to randomisation), aneurysm of brain artery, retinopathies, bleeding of vitreous body, endocarditis lenta or septica)
- •Renal and urethra calculi
研究者
相似试验
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