Role of Prophylactic Tranexamic Acid in Reducing Blood Loss During Elective Caesarean Section for Placenta Praevia Major: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major
研究概览
简要总结
Prophylactic tranexamic acid will reduce blood loss during Caesarean section for placenta praevia
详细描述
Tranexamic acid is a promising agent, easy to administer, cheap, and can be added to the other routine management in hospitals deliveries. This study aims to document the efficacy of intravenous tranexamic acid in reducing blood loss during and after caesarean section in placenta praevia major patients and to assess the Hb and platelet change after its administration.
General objective:
To investigate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section for placenta praevia major
Specific objectives:
- To evaluate the effect of prophylactic IV tranexamic acid in reducing blood loss during Caesarean section up to 2 hours after Caesarean section.
- To evaluate the drop in Haemoglobin level postoperatively with the use of prophylactic IV tranexamic acid for Caesarean section for PP major
- To examine the effect of tranexamic acid on platelet level for caesarean section for PP major
- To observe the side effects of tranexamic acid
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 (Participant, Care Provider, Investigator)
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
- •all placenta previa major pregnant women
排除标准
- •Any cardiac disorder or liver disease
- •Patient on anticoagulant therapy
- •History of allergy to tranexamic acid
- •Any contraindication for tranexamic acid
研究组 & 干预措施
Tranexamic acid group
Tranexamic acid group will receive 1g slow bolus of tranexamic acid over 2 minutes at least 5 minutes before skin incision (at the end of spinal/general anaesthesia)
干预措施: Tranexamic acid injection (Drug)
Control group
The placebo group will receive normal saline 0.9% (same amount as the tranexamic acid)
干预措施: Normal Saline 0.9% (Drug)
结局指标
主要结局
To evaluate the effect of prophylactic IV tranexamic acid in amount of blood loss during Caesarean section in placenta previa major
时间窗: 24 hours
Amount of blood loss in mls
To evaluate the effect of prophylactic IV tranexamic acid in the changes of haemoglobin during Caesarean section in placenta previa major
时间窗: 24 hours
changes of haemoglobin level
次要结局
- To evaluate the side effects of tranexamic acid(one week)
研究者
Chew Kah Teik
Clinical lecturer and gynaecologist
Universiti Kebangsaan Malaysia Medical Centre