Effect of Rectal Misoprostol in Reducing Intra-operative Blood Loss During Myomectomy A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
A total of 200 women for elective abdominal myomectomy were randomly allocated into two groups.
100 women in experimental group were administered 400ug Misoprostol (2 tablets of Prosotec®) through the rectal route prior to surgery and 100 were in control group, in which no drug was administered.
详细描述
After getting approval from hospital's ethical committee, patients eligible for the study were recruited in the study according to the selection criteria. Before surgery, after taking informed written consent, patient's detailed history including demographics, parity & BMI was recorded. Uterine size was assessed by bimanual pelvic examination. Patients undergoing myomectomy were randomly divided into 2 groups using lottery method. In experimental group Misoprostol 400ug was administered per rectally prior to surgery. In control group, no drug was administered.
The surgical procedural elements, the surgeon or surgeons performing the procedure and the use of antibiotics as well as anesthetic agents was standardized to remove any bias. Intraoperative blood loss was recorded by a single trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
There will be a single trained person who calculated the intra-operative blood loss and was blinded to the randomization of the patients and the use of medication.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ASA physical status class I-II
- •Intramural or subserosal fibroids - diagnosed on ultrasound
- •Candidates for elective abdominal myomectomy
排除标准
- •Pre-operative Hemoglobin < 10 g/dl
- •Patient who received Danazol or GnRH analogues before surgery
- •No other systemic or metabolic disease
研究组 & 干预措施
Misoprostol (Study Group)
In study group, 400ug misoprostol will be administered through rectal route, 1 hour before surgery.
干预措施: Misoprostol (Drug)
结局指标
主要结局
Intraoperative blood loss
时间窗: During the surgical procedure
Intraoperative blood loss will be recorded by a trained doctor and calculated using visual scale for the abdominal sponges and chest swabs/gauzes used during surgery and blood collected in suction bottle.
次要结局
未报告次要终点
研究者
Salma Nisar
Resident OBGYN
Pak Emirates Military Hospital