Comparative Safety and Efficacy of Intravenous Tranexamic Acid Versus IV Carbetocin in Reducing Blood Loss During Abdominal Myomectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 153
- 主要终点
- intraoperative blood loss
研究概览
简要总结
the aim of the present study is to compare safety and efficacy of intravenous tranexamic acid versus IV carbetocin in reducing blood loss during abdominal myomectomy: a randomized controlled trial
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
- •women with symptomatic fibroids candidate for abdominal myomectomy with staging of myoma from (3 to 6) according to FIGO staging
排除标准
- •women with Myoma FIGO staging (1,2,7 and 8) candidate for laparoscopic or hysteroscopic myomectomy, women with allergy or contraindications to carbetocin or tranexamic acid
研究组 & 干预措施
intravenous carbetocin
The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision
干预措施: intravenous carbetocin (Drug)
placebo
the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision
干预措施: placebo (Drug)
intravenous tranexamic acid
The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision
干预措施: intravenous tranexamic acid (Drug)
结局指标
主要结局
intraoperative blood loss
时间窗: one hour
the intraoperative blood loss in ml will be estimated during the procedure
次要结局
- need for blood transfusion(24 hours)
研究者
Ahmed Samy aly ashour
assistant professor obstetrics and gynecology
Cairo University