Low Dose Aspirin in the Prevention of Preeclampsia in Chinese Pregnant Women.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Prevention of preeclampsia
研究概览
简要总结
Preeclampsia is one of the three leading causes of maternal morbidity and mortality all over the world. The use of low dose aspirin has been mentioned in several studies with promising results. The investigators decided to evaluate the use of low dose aspirin in Chinese pregnant women, starting between 12+ and 20 weeks of pregnancy, based on clinical characteristics aiming to reduce the incidence of preeclampsia.
详细描述
Detailed Description:
The investigators will conduct a randomized control trial to estimate the efficacy of low dose aspirin in preventing preeclampsia in Chinese pregnant women who are evaluated with risk factors. The investigators will also obtain biological specimen including maternal blood, cord blood, placenta specimen and etc. for basic science studies.
Rationale for Design:There is a lack of evidences or guideline of aspirin using in preventing PE for Chinese women. The investigators will conduct a randomized control trial, which is the 'gold standard' of research design, hoping to answer the question.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Gestational age between 12+ and 20 weeks of pregnancy
- •High risk of preeclampsia, based in clinical risk factors as:
- •2.1 if they have one or more of the following risk factors： Preeclampsia in a previous pregnancy ,Diabetes Mellitus(Type 1 or 2),Chronic Hypertension .
- •2.2 if they have two or more of the following risk factors: Pre-pregnancy Body Mass Index ≥28kg/m2, Elderly pregnancy(age ≥35 years), Mother or sisters with preeclampsia in a previous pregnancy, Primiparity or Famliy history (Mother or sister that developed preeclampsia in a previous pregnancy）.
- •Signed informed consent.
排除标准
- •Allergy to aspirin
- •Peptic ulcers
- •Severe heart, liver, renal disease who can not burden the experiment
- •Rheumatic immune disease
- •Mental disease
- •Alcohol and drug abuse
- •Being in another drug experiment within 3 months
- •Difficult to follow-up
研究组 & 干预措施
aspirin
Low dose aspirin (100 mg) starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy, taking at night.
干预措施: Aspirin (Drug)
blank
Routine examination during pregnancy.
干预措施: Blank (Other)
结局指标
主要结局
Prevention of preeclampsia
时间窗: 6 months
The number of cases of preeclampsia that appear in both groups before 34 weeks of pregnancy.
次要结局
- Maternal hemorrhage and neonatal intracranial hemorrhage(6 months)
- Preterm birth(6 months)
- Prevention of preeclampsia at term(6 months)
- Fetal Growth Restriction(6 months)
- Abruptio placenta(6 months)
研究者
Li Lin
PhD
Peking University First Hospital