Efficacy of Tranexamic Acid in Reducing Blood Loss During and After Caesarean Section
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Amount of blood loss calculated using statistical measurements to determine the total decrease in HB and Hematocrit levels following the CS
研究概览
简要总结
The aim of this study is to evaluate the efficacy of tranexamic acid in reducing blood loss during and after elective C.S.
The Research Question Is Tranexamic acid effective in reducing blood loss during and after elective Caesarean section?
The Research Hypothesis The TXA could be able to reduce blood loss during and after elective Caesarean section.
The null hypothesis will therefore state that:
There will be no difference between TXA and placebo in reducing blood loss during and after elective Caesarean section.
详细描述
Caesarean Section (C.S) is the most common major surgical procedure performed on women worldwide and its rates continue to rise steadily in both developed and developing countries (Gibbons et al., 2012).
Caesarean Section is associated with more blood loss than vaginal delivery; there is a trend for increasing rates in both developed and developing countries (Betra´n, 2007).
The National US Caesarean section rate leveled off at 32.8% in 2010 and 2011 (Hamilton et al., 2012).
Caesarean Section accounts for 20-25% of all deliveries in the UK (Fairley Dundas, 2011).
C.S rates have increased to as high as 25-30 % in many areas of the world, in Pakistan the (C.S) rate is 25% (Najmi, 2000).
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 (Investigator, Outcomes Assessor)
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 women aged 20-40 with singleton fetus 38 or more weeks
- •Uncomplicated pregnancy, up to 3rd parity
- •Women undergoing scheduled elective C.S
排除标准
- •Causes of uterine over-distention such as polyhydramnios or macrosomia
- •Grand multi parity
- •Previous PPH (3 x risk) or previous history of retained placenta
- •Pre-eclampsia or pregnancy-induced hypertension
- •Maternal hypertension
- •Pre-existing maternal hemorrhagic conditions
- •Maternal diabetes mellitus
- •Abnormal placenta
- •Sensitivity to TXA
- •Women taking anticoagulant therapy
研究组 & 干预措施
cases
Women assigned to the study group will receive 1 gr of Tranexamic acid injection (Kapron, AMOUN Pharmaceutical co.) given slowly I.V over 10 minutes before the operation.
干预措施: Tranexamic Acid (Drug)
control
The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study.
干预措施: Glucose (Drug)
结局指标
主要结局
Amount of blood loss calculated using statistical measurements to determine the total decrease in HB and Hematocrit levels following the CS
时间窗: 6 months
Assessment of the intra-operative blood loss will be started after the uterine incision by collection of the suctioned blood and by weighing surgical towels. Post-operative blood loss will be assessed during the first 24 hour by weighing the pads. HB level \& Hematocrit will be investigated before and 24 hours after surgery. The weight of the dry towels will be subtracted from the weight of wet towels and the weight of the blood will change in to volume using the formula {density of blood is 1060/m3; slightly denser then water so volume of the blood = weight multiply 0,9}). Sample size determination: Assuming a rate of intraoperative blood loss ranging between 650ml in group 1 \& 450ml in group 2 with a SD of 300ml, a sample size of 48 patients in each group is enough to detect such difference, if true, at 0,05 alpha error and 0,09 power of the test (Kemal, 2010).
次要结局
未报告次要终点
研究者
Zarafshan Mohammad Raqeeb
Student
Ain Shams University