NCT04083625已完成4 期
the Effect of Carbetocin in Decreasing Intraoperative Blood Loss in Abdominal Myomectomy: a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Mean amount of intraoperative blood loss
研究概览
简要总结
To investigate the effectiveness of carbetocin on 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
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Patients presenting for abdominal myomectomy with documented uterine fibroids on pelvic imaging
- •Age ≥ 25 years and ≤ 50 years
- •Pre-operative hemoglobin >10 g/dl
- •Ability to understand and the willingness to sign a written informed consent.
- •Admissible medical/surgical history
- •Five or less symptomatic uterine myomas
- •symptomatic stage 3 to 6 fibroids, according to FIGO staging
排除标准
- •• Post-menopausal women
- •Patients with known bleeding/clotting disorders
- •Patients with a history of gynecologic malignancy
- •Hypertension.
- •Cardiac and Pulmonary diseases.
- •History of allergic reactions attributed to carbetocin
研究组 & 干预措施
carbetocin
Experimental
100microgram in 10 cm syringe carbetocin IV just before skin incision of myomectomy.
干预措施: carbetocin 100 mcg (Drug)
placebo
Placebo Comparator
10 cm syringe normal saline IV given just before skin incision of myomectomy.
干预措施: placebo (Drug)
结局指标
主要结局
Mean amount of intraoperative blood loss
时间窗: intraoperative
Mean amount of intraoperative blood loss in ml
次要结局
未报告次要终点
研究者
Ahmed Samy aly ashour
assistant professor
Cairo University
研究点 (1)
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