Preoperative Vaginal Dinoprostone Versus Misoprostone to Decrease Bleeding During Abdominal Myomectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Blood loss
研究概览
简要总结
Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy
详细描述
Background; Myomectomy is a curative interventional option for many kinds of uterine fibroids, but considerable intraoperative haemorrhage and the necessities for transfusions of blood are still the main challenge for abdomen myomectomy.
Aim and objectives; To compare the efficacy of preoperative administration of dinoprostone 20 mg versus 400 ug misoprostol vaginally in decreasing the amount of bleeding during abdominal myomectomy Subjects and methods; This was a prospective randomized double-blind controlled study that included 90 patients complaining of uterine myoma and indicated for myomectomy selected from the outpatient clinic at Beni-suef university hospital
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 30-50 years
- •all cases with uterine fibroid not responding to medical treatment and indicated for myomectomy.
排除标准
- •contraindications to dinoprostone or misoprostol,
- •active PID,
- •history of pelvic/ ovarian endometriosis,
- •females who had pre-operative mifepristone, GnRH analog or orally contraception drugs, earlier myomectomy.
研究组 & 干预措施
Dinoprostone
Will receive 20 mg of Dinoprostone vaginally 2 hrs. preoperatively.
干预措施: Dinoprostone (Drug)
Misoprostol
will receive 400 μg of Misoprostol vaginally 2 hrs. preoperatively.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Blood loss
时间窗: all time of the myomectomy operation
quantity of blood collected in the aspiration apparatus and the quantity of blood on the operative gauze.
次要结局
- change hemoglobin levels(within 1 week before operation and 24 hours after operation)
研究者
Sara Abdallah Mohamed Salem
Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
Beni-Suef University