Role of Tranexamic Acid in Control of Intraoperative Blood Loss in Women Undergoing Elective Cesarean Section
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Blood Loss
研究概览
简要总结
This clinical trial was done to find out if tranexamic acid (TXA) can safely reduce the amount of blood loss during cesarean (C-section) deliveries. Heavy bleeding is a major risk during childbirth, especially in C-sections, and can be life-threatening.
The main question this study wanted to answer was:
Does giving tranexamic acid before surgery reduce the amount of blood lost during a planned C-section?
In this study, 68 women who were scheduled for elective (planned) C-section deliveries were randomly assigned to receive either tranexamic acid or a placebo (a look-alike substance with no medicine in it) before surgery. The medication was given by slow injection just 15 minutes before the operation.
All surgeries followed the same procedure and were done by experienced obstetric surgeons. The amount of blood lost during surgery was carefully measured and compared between the two groups.
The goal was to find a simple and safe way to lower the risk of blood loss and its complications during C-sections, improving outcomes for mothers.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 20-45 years
- •at 37-40 weeks of gestation (on LMP)
- •Planned to undergo cesarean section under spinal anesthesia
排除标准
- •Women with previous history of thromboembolic events
- •Allergy to tranexamic acid
- •Women with morbidly adherent placenta (on antenatal USG)
研究组 & 干预措施
Intravenous Tranexamic Acid
Patients received 1 g (10 ml) of tranexamic acid diluted in 20 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.
干预措施: Tranexamic Acid (IV) (Drug)
Intravenous Tranexamic Acid
Patients received 1 g (10 ml) of tranexamic acid diluted in 20 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.
干预措施: Dextrose 5% (D5W) (Drug)
Intravenous 5% Dextrose
Patients in this group received 30 mL of glucose 5%. Fifteen minutes before the surgery, the solution was injected intravenously slowly over a period of 5 minutes.
干预措施: Dextrose 5% (D5W) (Drug)
结局指标
主要结局
Blood Loss
时间窗: During the elective cesarean section procedure
Intraoperative blood loss (ml) was measured by taking weight difference of the dressings and towels before and after the operation plus blood added to the fluid volume inside the suction apparatus.
次要结局
未报告次要终点
研究者
Hania Wahid
Principal Investigator
Combined Military Hospital Multan