Evaluating Safety and Efficacy of Tranexamic Acid Versus Vaginal Misoprostol in Reducing Intraoperative Blood Loss During Abdominal Myomectomy
试验速览
- 阶段
- 4 期
- 入组人数
- 162
- 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 tranexamic acid versus vaginal misoprostol 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
- Prevention
- 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
- •myomas candidate for laparoscopic or hysteroscopic myomectomy and allergy or contraindications to misoprostol or tranexamic acid
研究组 & 干预措施
intravenous tranexamic acid
patients were given a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision plus one vaginal placebo tablet 1 hour before skin incision
干预措施: intravenous tranexamic acid (Drug)
vaginal misoprostol
patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
干预措施: vaginal misoprostol (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: placebo (Drug)
结局指标
主要结局
intraoperative blood loss
时间窗: one hour
intraoperative blood loss will be estimated during open myomectomy in mL
次要结局
未报告次要终点
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University