Prophylactic Role Of Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery : A Prospective Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Perioperative blood loss
研究概览
简要总结
Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The women undergoing cesarean delivery (both elective and emergency) during the study period.
- •Willing to participate in the study after understanding the concept.
排除标准
- •Critically ill patient.
- •Not willing to give consent to participate in the study
- •Cases diagnosed with a ruptured uterus or undergoing caesarian hysterectomy during operation.
研究组 & 干预措施
Group A
All women recruited to Group A will receive tranexamic acid 1 gram in 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision.
干预措施: Tranexamic acid injection (Drug)
Group B
All women recruited to Group A will receive 100 ml Normal Saline as intravenous infusion 10 minutes before the skin incision, as placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Perioperative blood loss
时间窗: Amount of blood loss from starting from surgical incision till 24 hours post caesarean section.
The primary aim of the trial is to investigate the effect of tranexamic acid on peri and post- operative blood loss during caesarean section
次要结局
未报告次要终点
研究者
MUAZZAM HASAN
Associate Professor
Aligarh Muslim University