Efficacy of Tranexamic Acid In Reducing Blood Loss Among Pregnant Women During Cesarean Section Because Of Placenta Previa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 主要终点
- Amount of Actual blood loss in each group
研究概览
简要总结
This study evaluate role of tranexamic acid in reducing blood loss among pregnant women undergoing cesarean section because of placenta previa .Half of participants will receive tranexamia acid drug While the other half will receive placebo.
详细描述
Tranexamic Acid used in the field of obstetrics to decrease blood loss during and after cesarean section .
Tranexamic Acid is an antifibrinolytic agent which cause reversible and competitive blockade of the lysine binding sites in plasminogen molecules . It is a synthetic analog of amino acid lysine and its action is to reduce blood loss
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18 -38 Body mass index <30 , Diagnosis of placenta previa
排除标准
- •patient with bleeding disorder , hepatic and renal disease. contraindication to tranexamic acid as allergy , hypersensitivity to tranexamic acid and known thromboembolic event during pregnancy .
- •other causes ofantepartum haemorrhage eg :accidental haemorrhage, rupture uterus.
- •type 1,2 of placenta previa anterior type 3,4 of placenta previa posterior causes of overdistended uterus like :multiple pregnancy, polyhydraminos
研究组 & 干预措施
tranexamic acid group
tranexamic acid given as 1 gram intravenous dose dilute in 500 cc of ringer lactate 20 minute before cesarean section
干预措施: Tranexamic Acid (Drug)
placebo group
the control group will receive 500 cc of ringer lactate 20 minute before cesarean section
干预措施: Tranexamic Acid (Drug)
结局指标
主要结局
Amount of Actual blood loss in each group
时间窗: 6hour after operation
observational
次要结局
- Difference in haemoglobin before operation and 24 hours after operation(24 hours)
研究者
shaimaa- sayed
Director , Clinical Research
Medical Research Council