A Prospective Muti-center Study of Early Prediction and Randomised Prevention of Preeclampsia With Low Dose Aspirin in Chinese Cohort
试验速览
- 阶段
- 4 期
- 入组人数
- 1,500
- 主要终点
- the rate of preeclampsia
研究概览
简要总结
This study intends to adopt the method of multi-center prospective randomized controlled study. The aim of this study is to obtain localized excision values through a preeclampsia screening model established in early pregnancy, and to evaluate the efficacy of low-dose aspirin intervention for preeclampsia prevention in pregnant women at high risk of screening.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women assessed as at high risk of preeclampsia 2) live pregnancy 3) gestational weeks < 16 weeks 4) agree to randomized drug intervention studies 5) follow up regularly and obtain reliable pregnancy outcomes
排除标准
- •with severe fetal or chromosomal abnormalities 2) induced labor or spontaneous abortion due to social factors 3) absolute or relative contraindications to aspirin use (allergy to aspirin or other salicylate, or other ingredients of the drug;Acute gastrointestinal ulcer;Active bleeding;In patients with severe G6PD deficiency, acetylsalicylic acid may induce hemolysis or hemolytic anemia.Aspirin asthma)
研究组 & 干预措施
aspirin group
aspirin,tablet,100/150mg per day,(BMI<30 100mg/d，BMI≥30 150mg/d)，from pregnancy weeks<16 to 35 weeks or the day of delivery.
干预措施: Aspirin (Drug)
control group
with no intervention
干预措施: Aspirin (Drug)
结局指标
主要结局
the rate of preeclampsia
时间窗: through study completion, an average of 1 year
Hypertensive onset after 20 weeks of gestation is accompanied by proteinuria,or with thrombocytopenia, impaired liver function, renal insufficiency,pulmonary edema,headache without other explanation and so on.
the rate of fetal growth restriction
时间窗: through study completion, an average of 1 year
The birth weight of the fetus is below two standard deviations of the average weight for the same gestational age or below the 10th percentile of normal weight for the same age
the rate of hypertensive disorder during pregnancy
时间窗: through study completion, an average of 1 year
gestational hypertension, preeclampsia, chronic hypertension with preeclampsia, eclampsia, HELLP syndrome
the rate of placenta abruption
时间窗: through study completion, an average of 1 year
After 20 weeks of pregnancy, the placenta in its normal position is completely or partially removed from the uterine wall before delivery of the fetus
the rate of postpartum hemorrhage
时间窗: within 24 hours after the delivery
Within 24 hours after the delivery of the fetus, the bleeding volume of vaginal delivery ≥500ml, cesarean delivery ≥1000ml
the time and type of delivery
时间窗: within 24 hours after the delivery
gestational week, vaginal delivery and cesarean section
次要结局
- birth weight of newborn(delivery time)
- Apgar score for newborns(delivery time)
- the rate of Neonatal NICU occupancy rate(through study completion, an average of 1 year)