Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Placebo to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- blood loss during and after cesarean delivery
研究概览
简要总结
Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.
详细描述
Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant females admitted for Elective Cesarean Section.
- •Gestational age of pregnancy (38 weeks To 40 weeks).
- •the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.
- •Singleton living fetus.
- •No medical disorders.
- •Informed Oral Consent From The Patient.
排除标准
- •Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits).
- •Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).
- •Acute liver or kidney diseases; blood disorders, such as anaemia.
- •Allergy to Tranexamic acid.
- •Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.
- •Ante partum Hemorrhage such placental abruption.
研究组 & 干预措施
Oxytocin
Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision
干预措施: Oxytocin (Drug)
Tranexamic acid and Etamsylate
Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery
干预措施: Oxytocin (Drug)
Saline
Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section
干预措施: Oxytocin (Drug)
结局指标
主要结局
blood loss during and after cesarean delivery
时间窗: First 2 hours after C-Section
Measuring of Hemoglobin level and Hematocrit level pre and post operatively.
次要结局
- post operative bleeding(first 24 hours after C-Section)