Phase 1 Study of Misoprostol in Reducing Intraoperative Bleeding in Myomectomy Operations
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- intraoperative blood loss
研究概览
简要总结
The aim of this research work is to assess the effect of using single preoperative dose of rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the operation and possible operative complications
详细描述
This study is a randomized, double-blind, controlled study that will be conducted in Ain Shams University Maternity Hospital.
A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be included in this study after taking their consent for this clinical trial after full explanation of the trial.
The total of 50 included patients will be divided into two groups: Group A (Study group;): will Include 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will Include 25 patients undergoing myomectomy operation will not receive misoprostol before 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal patients aged between 35 to 50 years old.
- •Five or less symptomatic uterine myomas .
- •Maximum diameter of the largest myoma is 6 cm .
- •All myomas are subserous or intramural.
- •Uterine size less than 24 weeks pregnancy
排除标准
- •History of previous surgery.
- •Allergy to Misoprostol.
- •Hypertension.
- •Cardiac and Pulmonary diseases.
- •Patients who have bleeding disorders.
- •Anemia (Hb < 10g %).
- •Chronic endocrine or metabolic diseases such as Diabetes.
- •Obesity (body mass index > 30 kg/m2).
- •Cases that will require intraoperative conversion of myomectomy to hysterectomy.
研究组 & 干预措施
Myomectomy, rectal Misoprostol
25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation.
干预措施: Misoprostol (Drug)
Myomectomy, Placebo
Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
干预措施: Placebo( for misoprostol) (Drug)
结局指标
主要结局
intraoperative blood loss
时间窗: time from peritoneum opening till its closure around (1 Hour)
次要结局
未报告次要终点
研究者
Dr.Ahmed Elnaggar
DR
Ain Shams University