NL-OMON43583招募中3 期
Anticoagulants for Living Fetuses in women with recurrent miscarriage and inherited thrombophilia; ALIFE2 study - ALIFE2 study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 200
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
- 年龄范围
- 18 至 99（—）
入选标准
- •-Women with recurrent miscarriage (>= 2) and/or intra-uterine fetal deaths (i.e. >= 2 miscarriages of intra-uterine fetal deaths, irrespective of gestational age;
- •-Confirmed inherited thrombophilia; factor V Leiden mutation, prothrombin gene mutation (G20210A), protein S deficiency, protein C deficiency or antithrombin deficiency or a combination hereof. Protein S, -C and antithrombin deficiencies need to be confirmed by two independent tests, performed on two separate occasions and not during pregnancy or anticoagulant therapy;
- •-Pregnancy confirmed by urine pregnancy test;
- •-Age 18 - 42 years at randomisation;
- •-Willing and able to give informed consent;
排除标准
- •-Duration of current pregnancy >= 7 weeks; based on first day of last menstruation.
- •-Indication for anticoagulant treatment during pregnancy (for instance prosthetic heart valves, a history of venous thromboembolism or antiphospholipid syndrome);
- •-Contraindications to LMWH (previous heparin induced thrombocytopenia, active bleeds or renal insufficiency with creatinine clearance of less than 30ml/min);
- •-Known allergy to at least 3 different LMWH preparations;
- •-Previous inclusion in the ALIFE2 study (for another pregnancy);
研究者
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