The Effectiveness of Low-dose Aspirin on Preventing Pre-eclampsia in High-risks Pregnant Women
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 600
- 主要终点
- Incidence of pre-eclampsia
研究概览
简要总结
This study will explore the effectiveness of low-dose aspirin on preventing pre-eclampsia in high-risks pregnant women by comparing the incidence of pre-eclampsia and pregnancy outcomes.
详细描述
Currently，low-dose aspirin is a commonly used drug to prevent pre-eclampsia. Many guidelines recommend starting low-dose aspirin in early pregnancy in high-risks pregnant women. However, the applicable population and use method of aspirin are still controversial in clinical practice. This study will explore the effectiveness and use method of low-dose aspirin by comparing the incidence of pre-eclampsia and pregnancy outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 18-55 years
- •Gestational age between 12-20 weeks of pregnancy
- •High risk of developing pre-eclampsia
- •At least one of the following risk factors: Pre-eclampsia in a previous pregnancy , Multiple pregnancy，Diabetes Mellitus(Type 1 or 2), Chronic Hypertension，Renal disease, Autoimmune disease.
- •At least two of the following risk factors: Primiparity，Pre-pregnancy Body Mass Index ≥28kg/m2, Age ≥35 years, Family members have a history of pre-eclampsia.
- •Maternal informed conset obtained
排除标准
- •Contraindication to aspirin therapy (including but not limited to allergy and high bleeding risk)
- •Patient with known intention to terminate pregnancy
- •Fetal abnormalities detected （including but not limited to major fetal malformation and FGR）
- •Severe heart, liver, renal disease who can not burden the experiment
- •Alcohol and drug abuse
- •Being in another drug experiment within 3 months
研究组 & 干预措施
75mg
Take 75mg of aspirin daily in tihis group
干预措施: Aspirin (Drug)
100mg
Take 100mg of aspirin daily in this group
干预措施: Aspirin (Drug)
结局指标
主要结局
Incidence of pre-eclampsia
时间窗: 1 year
Record the number of pre-eclampsia in each group and compare whether there are statistical differences in the incidence of each group
次要结局
- Postpartum hemorrhage(1 year)
- Preterm birth(1 year)
- Placental abruption 4/5000 Placental abruption(1 year)
- Fetal growth restriction(1 year)