Evaluating Safety and Efficacy of Intravenous Tranexamic Acid Versus Vaginal Dinoprostone in Reducing Intraoperative Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 180
- 主要终点
- intraoperative blood loss
研究概览
简要总结
the aim of the present study is to evaluate safety and efficacy of intravenous tranexamic acid versus vaginal dinoprostone in reducing intraoperative blood loss during abdominal myomectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •symptomatic fibroids candidate for abdominal myomectomy
排除标准
- •patients candidate for laparoscopic or hysteroscopic myomectomy or had contraindications or allergy to dinoprostone or tranexamic acid
研究组 & 干预措施
intravenous tranexamic acid
patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.
干预措施: intravenous tranexamic acid (Drug)
vaginal dinoprostone
patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
干预措施: vaginal dinoprostone (Drug)
placebo
patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
干预措施: vaginal placebo (Drug)
结局指标
主要结局
intraoperative blood loss
时间窗: one hour
estimation of intraoperative blood loss in ml
次要结局
- blood transfusion(24 hours)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University