EUCTR2015-002357-35-GB进行中（未招募）1 期
Anticoagulants for Living FoEtuses in women with recurrent miscarriage and inherited thrombophilia : ALIFE 2 - ALIFE 2
Research, Development & Innovation Department, UHCW NHS Trust0 个研究点目标入组 400 人开始时间: 2015年7月16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
- 400
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
- •Inclusion criteria (at Registration)
- •Provision of written informed consent
- •Women with recurrent miscarriage and/or intra-uterine foetal deaths (i.e. = 2 consecutive or non-consecutive miscarriages of intra-uterine foetal deaths, irrespective of gestational age)
- •Inherited thrombophilia; confirmed by factor V Leiden mutation, prothrombin gene mutation (G20210A), protein S deficiency, protein C deficiency or antithrombin deficiency or a combination hereof.
- •(Protein S, protein C and antithrombin deficiencies need to be confirmed by two tests, performed on two separate occasions and not during anticoagulant therapy. Protein S tests should not be performed during pregnancy or in the 6-week post-partum period since spuriously low levels may then be observed).
- •Age 18 - 42 years*
- •*participants that are registered at age 42 must also be aged 42 at the time pregnancy is confirmed and they are randomised onto the trial. Registered participants that turn 43 prior to becoming pregnant should be informed they will not be eligible to be randomised on to the ALIFE2 trial.
- •Additional Inclusion Criteria (at randomisation)
- •Pregnancy confirmed by urine pregnancy test in hospital (<7 weeks gestation – based on first day of last menstruation or confirmed via ultrasound scan).
- •Age 18 - 42 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Exclusion criteria (for registration)
- •Duration of current pregnancy = 7 weeks, based on first day of last menstruation or confirmed via ultrasound scan.
- •Weight = <50kg
- •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, osteoporosis, hyperaldosteronism)
- •Known allergy to at least 3 different LMWH preparations
- •Previous inclusion in the ALIFE2 study (for another pregnancy)
- •Participation in a clinical trial of an investigational medicinal product in the last 90 days.
研究者
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