NCT02709564已完成3 期
Single Dose Versus Two Doses of Sublingual Misoprostol in Decreasing Blood Loss Prior to Abdominal Myomectomy: A Randomized Double-blinded Clinical Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 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 sublingual administered prostaglandin E1 synthetic analogue (misoprostol) 400 microgram 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
- Triple (Participant, Care Provider, Investigator)
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
Group A
Placebo Comparator
400 mg placebo
干预措施: placebo 400 sublingual (Drug)
Group B
Active Comparator
400 microgram misoprostol
干预措施: Misoprostol 400 sublingual (Drug)
结局指标
主要结局
Mean amount of intraoperative blood loss
时间窗: intraoperative
次要结局
- Change of hemoglobin after surgery(24 hours)
研究者
研究点 (1)
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