Misoprostol Versus Uterine Striating by Bladder Filling for Pain Relief During Office Hysteroscopy. A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Intensity of pain [ visual analogue scale ranging from 0 to 10 ]
研究概览
简要总结
The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.
详细描述
Several studies revealed that cervical ripening with misoprostol is effective in reducing pain especially in postmenopausal patients. A recent randomized controlled trial revealed that uterine striating by bladder filling prior to office hysteroscopy is associated with reduced pain perception and easier introduction of hysteroscope through the cervix.
The aim of this study is to compare the effectiveness of misoprostol versus uterine straightening by bladder filling for pain relief in menopausal patients undergoing office hysteroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Menopausal patients who have an indication for office hysteroscopy
排除标准
- •Nulliparous patients, patients with cervical pathology and previous cesarean section or cervical surgery.
研究组 & 干预措施
Misoprostol
Misoprostol (400µg) is administered vaginally 12 hours before office hysteroscopy
干预措施: Misoprostol (Drug)
bladder Filling
Uterine straightening by bladder filling before office hysteroscopy
干预措施: Bladder Filling (Other)
结局指标
主要结局
Intensity of pain [ visual analogue scale ranging from 0 to 10 ]
时间窗: Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 10 minutes] and 30 minutes after the procedure
次要结局
- Operative time(From the introduction of hysteroscope into the vagina till compilation of hysteroscopic examination[ an expected average 10 minutes])