NCT04051567Unknown4 期
Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin Pregnancies--A Multicenter, Prospective, Open, Randomized, Controlled Clinical Trial
Ministry of Science and Technology of the People´s Republic of China1 个研究点 分布在 1 个国家目标入组 425 人开始时间: 2018年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 425
- 试验地点
- 1
- 主要终点
- The incidence of preeclampsia, preterm birth, fetal growth restriction
研究概览
简要总结
Twin pregnancies are associated with increased risk of perinatal adverse outcomes , including preeclampsia , fetal growth restriction , preterm premature rupture of membranes and preterm birth. Low-dose aspirin was recommend by American College of Obstetricians and Gynecologists (ACOG) during pregnancy. In this trial, the investigators suppose that aspirin used in twin-pregnancies could improve adverse 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
- Triple (Participant, 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
- 是
入选标准
- •Twin pregnancy diagnosed by ultrasound and maternal age ranged from 18 to 55 years, Gestational age was less than 16w
排除标准
- •Diagnosed fetal anomalies, history of cervical cerclage, contraindications of aspirin, pre-existing renal or liver diseases or abnormal functions, coagulation disorders, history of PE, preterm birth or FGR, chronic hypertension
研究组 & 干预措施
LDA group
Experimental
干预措施: Aspirin 100mg (Drug)
结局指标
主要结局
The incidence of preeclampsia, preterm birth, fetal growth restriction
时间窗: after 30 weeks of gestional age
次要结局
未报告次要终点
研究者
Hongbo Qi
Professor
Ministry of Science and Technology of the People´s Republic of China
研究点 (1)
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