The Novel Immunomodulatory and Anticoagulant Therapies for Recurrent Pregnancy Loss
试验速览
- 阶段
- 4 期
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- live birth
研究概览
简要总结
In this clinical cohort study, the investigators are going to observe the efficacy of anti-coagulation and immune therapy in the treatment of 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 2 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 experienced severe 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.
- •having internal and surgical disease(after having variety of physical examination such as electrocardiogram/hepatic and renal function/blood routine and urine routine)
- •chromosome aberrations in anyone of the couple.
- •patients who have drugs contraindications
研究组 & 干预措施
aspirin+LMWH group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
干预措施: Aspirin (Drug)
aspirin+LMWH group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100U,hypodermic injection，qd
干预措施: Heparin (Drug)
aspirin+LMWH+immunoglobulin group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks
干预措施: Aspirin (Drug)
aspirin+LMWH+immunoglobulin group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks
干预措施: Heparin (Drug)
aspirin+LMWH+immunoglobulin group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks
干预措施: Immunoglobulin (Drug)
aspirin+LMWH+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
干预措施: Aspirin (Drug)
aspirin+LMWH+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
干预措施: Heparin (Drug)
aspirin+LMWH+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + prednisone,5-10mg/day,po,qd
干预措施: Prednisone (Drug)
aspirin+LMWH+IVIG+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
干预措施: Aspirin (Drug)
aspirin+LMWH+IVIG+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
干预措施: Heparin (Drug)
aspirin+LMWH+IVIG+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
干预措施: Prednisone (Drug)
aspirin+LMWH+IVIG+prednisone group
aspirin, 75-100mg/day, po,bid + low molecular weight heparin,4100IU/day,hypodermic injection,qd + immunoglobulin 300mg/kg（with 100ml normal saline）,intravenous injection,once every two weeks + prednisone,5-10mg/day,po,qd
干预措施: Immunoglobulin (Drug)
dydrogesterone group
dydrogesterone 20-30mg/day, po, tid
干预措施: Dydrogesterone (Drug)
结局指标
主要结局
live birth
时间窗: through study completion, an average of 3 year
live birth means success pregnancy（more than gestational age of 20 weeks）
次要结局
- D-dimer(through study completion, an average of 3 year)
- Uterine artery blood flow(through study completion, an average of 3 year)
- human chorionic gonadotropin(through study completion, an average of 3 year)
研究者
Shihua Bao
Principal Investigator
Shanghai First Maternity and Infant Hospital