Single Versus Double Dose Intra-vaginal Prostaglandin E2 "Misoprostol" Prior Abdominal Myomectomy: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 主要终点
- the operative time
研究概览
简要总结
Introduction: The study aimed to investigate the effectiveness of a single versus double dose of Prostaglandin E2 "Misoprostol, 400 microgram" during myomectomy for multiple uterine fibroids. This was a prospective randomized controlled trial comprised of 69 patients with multiple myomas undergoing myomectomy. Patients randomly allocated to either an intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases) or 2 doses, 3 and 1 hours, prior surgery (group B, 35 cases). Operation time, intra and post-operative blood loss, hemoglobin concentration, blood pressure and body's temperature were estimated and compared in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients had symptomatic multiple uterine fibroids (abnormal vaginal bleeding, lower abdominal dull aching pain and pelvic heaviness, subfertility or recurrent abortion)
排除标准
- •hypertension, cardiac and pulmonary disease, chronic endocrine or metabolic diseases such as diabetes, obesity (body mass index >30 kg/m2), all cases of single myoma and those known to be allergic to prostaglandin preparations.
研究组 & 干预措施
double dose misoprostol
2 doses, 3 and 1 hours, prior surgery (group B, 35 cases).
干预措施: 2 doses 400 microgram misoprostol (Drug)
single dose Misoprostol
intra-vaginal single dose of 400 microgram Misoprostol 1 hour pre-operatively (group A, 34 cases)
干预措施: single dose misoprostol (Drug)
结局指标
主要结局
the operative time
时间窗: from skin to skin in minutes
The time from start till end of surgery
intra and post-operative blood loss
时间窗: during and 6 hours after surgery
collected soaked towels and sucked blood
次要结局
未报告次要终点
研究者
ahmed M. badawy
professor
Mansoura University