NCT07078942尚未招募4 期
Effect of Preoperative Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section : A Randomized Controlled Trial
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
The purpose of this study is to asses the effect of preoperative prophylactic intravenous tranexamic acid on perioperative blood loss in pregnant women undergoing cesarean section
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women with gestational age 37-42 weeks
- •undergoing cesarean delivery with indication as follows: placenta previa, severe preeclampsia, myoma uteri, fetal macrosomia, polyhydramnios, grand multiparity ≥ 5 deliveries, prolonged labor, etc.
排除标准
- •history of allergy to tranexamic acid
- •history of venous thromboembolism (Deep vein thrombosis, Pulmonary embolism)
- •history of arterial thrombosis (Myocardial infarction, Stroke)
- •history of seizure, convulsion
- •have underlying of cardiovascular, renal or liver disease
- •using of antiplatelet or anticoagulant within 1 week before operation
- •placenta accreta spectrum
- •abruptio placenta
- •Eclampsia or HELLP (Hemolysis Elevated Liver Low Platelet) syndrome
- •Failed operative vaginal delivery
- •Multifetal gestation
研究组 & 干预措施
Tranexamic acid
Active Comparator
Tranexamic acid (1 g) 20 ml intravenous preoperation
干预措施: Tranexamic Acid (Drug)
Placebo
Placebo Comparator
Normal saline 20 ml intravenous preoperation
干预措施: Placebo (Other)
结局指标
主要结局
Blood loss
时间窗: From enrollment to the end of operation
blood loss in ml
次要结局
- early postpartum hemorrhage(From starting operation to 24-hour postoperation)
- delayed postpartum hemorrhage(From starting operation to 6 weeks postpartum)
- Adverse effects(from enrollment to 6 weeks postpartum)
- Neonatal outcomes(from starting operation to 10 minutes after birth)
研究者
Vorapong Phupong
Professor
Chulalongkorn University
研究点 (1)
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