Efficacy of tranexamic acid in reducing perioperative blood loss during caesarean section- a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- To assess the perioperative blood loss in caesarean section
研究概览
简要总结
This study is performed to evaluate the efficacy of tranexamic acid in reducing perioperative blood loss during caesarean section. A randomized controlled study will be conducted over a period of 1year 6 months on 76 pregnant women of ASA II, undergoing caesarean section under subarachanoid block. All patients are subjected to a thorough preanesthetic evaluation, the study is explained in detail and written informed consent is obtained. Patients are randomly divided into two groups of 38 each. 10 minutes before the incision, group A receives 100ml of normal saline and group B receives 1gm of tranexamic acid in 100ml of normal saline.Effectiveness of tranexamic acid in reducing perioperative blood loss will be assessed by estimating mean haemoglobin(Hb) mass loss which is obtained from patient’s Hb preoperatively and 48 hrs after caesarean section and the blood volume, which is calculated using Nader’s formula. Data analysis will be done using appropriate statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •ASA 2 parturients for elective caesarean section.
- •Singleton pregnancy.
排除标准
- •Hemodynamically unstable pregnant women.
- •Patients with history of DVT and other thromboembolic events in the past.
结局指标
主要结局
To assess the perioperative blood loss in caesarean section
时间窗: 48hr after caesarean section
次要结局
- Adverse drug reaction of tranexamic acid(Perioperative, 48hours after surgery)