ISRCTN53717039已完成未知
Effectiveness of dalteparin therapy as intervention in recurrent pregnancy loss
Friedrich Schiller University Jena (Friedrich-Schiller-Universität Jena) (Germany)0 个研究点目标入组 449 人开始时间: 2007年1月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 449
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Single pregnancy, fifth to eighth week of gestation
- •2. Documented foetal heart activity in UltraSound (US)
- •3. History of recurrent pregnancy loss, defined as:
- •a. two or more early (less than 12 weeks of gestation) pregnancy losses, or
- •b. one or more late (more than 12 weeks of gestation) pregnancy loss
- •4. Aged more than 18 years
- •5. Written informed consent of the patient
排除标准
- •1. Previous pregnancy losses caused by foetal structural or chromosomal anomalies
- •2. Uterine anomalies
- •3. Maternal infection, which caused previous pregnancy loss
- •4. Risk group II or III according to EThIG study (Effectiveness of Thromboseprophylaxe as intervention in the Gravidität) risk stratification (clinical need for heparin prophylaxis)
- •5. Acute thromboembolic event (need of heparin therapy)
- •6. Known hypersensitivity to any of the trial drugs or its ingredients (i.e. thrombocytopenia type II caused by allergic reaction to heparin
- •7. Anti-phospholipid antibody syndrome
- •8. Diabetes mellitus
- •9. Ongoing nicotine or drug or alcohol abuse
- •10. Human Immunodeficiency Virus (HIV) positive
- •11. Expected low compliance (e.g. by travel distance to trial site)
- •12. Current or recent (within 30 days prior to start of trial treatment) treatment with another investigational drug or participation in another investigational trial
研究者
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