NCT04080375Unknown3 期
the Effectiveness of Preoperative Vaginal Dinoprostone in Reducing Blood Loss During Abdominal Myomectomy:a Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 主要终点
- Mean amount of intraoperative blood loss
研究概览
简要总结
The aim of the study is to compare the effectiveness of vaginal dinoprostone 3 mg versus placebo before myomectomy to decrease blood loss during and after the operation.
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
- 18 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 ≥ 18 years and ≤ 50 years
- •Pre-operative hemoglobin >8 g/dl
- •Ability to understand and the willingness to sign a written informed consent.
- •Admissible medical/surgical history
- •Five or less symptomatic uterine myomas
- •All myomas are subserous or intramural.
- •Uterine size less than 24 weeks pregnancy
排除标准
- •• Patients who have had a prior abdominal myomectomy
- •Post-menopausal women
- •Patients with known bleeding/clotting disorders
- •Patients with a history of gynecologic malignancy
- •Hypertension.
- •Cardiac and Pulmonary diseases.
- •Obesity (body mass index > 30 kg/m2).
- •History of allergic reactions attributed to misoprostol
- •Cases that will require intraoperative conversion of myomectomy to hysterectomy.
研究组 & 干预措施
dinoprostone 3 mg
Experimental
patients will take 1 tablet of vaginal dinoprostone 1 hour before the surgery
干预措施: Dinoprostone 3 mg (Drug)
placebo
Placebo Comparator
patients will take 1 tablet of placebo 1 hour before the surgery
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
- Change of hemoglobin after surgery(24 hours)
研究者
Ahmed Samy aly ashour
assistant professor
Cairo University
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