NCT02986594Unknown4 期
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- D-Dimer
研究概览
简要总结
In this clinical cohort study, the investigators observe the efficacy of low molecular weight heparin in the treatment of thrombophilia with recurrent pregnancy loss with a prospective randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman who had their Second miscarriage before 12(th) week of gestation.The patient who is diagnosed as thrombophilia with recurrent pregnancy loss. Signed consent form.
排除标准
- •having experiencedsevere allergies, trauma history and/or operation history within 3 months
- •with a history of mental illness and/or family history of mental illness
- •limb disabled
- •taking medicine within one month
- •suffering major events or having mood swings
- •with a history of recurrent pregnancy loss
- •having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine rotine)
- •Chromosome aberrations in anyone of the couple.
- •patients who have drug contraindications
研究组 & 干预措施
aspirin group
Experimental
low dose aspirin, 75-100mg, bid, after pregnancy
干预措施: Aspirin (Drug)
low molecular weight heparin group
Experimental
low molecular weight heparin, 4100u, qd, after pregnancy
干预措施: Heparin (Drug)
combination group
Experimental
low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy
干预措施: Aspirin (Drug)
combination group
Experimental
low molecular weight heparin, 4100u, once a day and low dose aspirin, 75-100mg, bid. After pregnancy
干预措施: Heparin (Drug)
结局指标
主要结局
D-Dimer
时间窗: through study completion, an average of 3 year
次要结局
- BMI in kg/m^2(through study completion, an average of 3 year)
研究者
Shihua Bao
Principal Investigator
Shanghai First Maternity and Infant Hospital
研究点 (1)
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