NCT01612065已完成3 期
The Optimum Dose of Vaginal Misoprostol Prior to Office Hysteroscopy: Double Blind Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
Misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.
详细描述
The investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , Infertile patient, patients with abnormal bleeding and patient with recurrent abortion Outcome measure: pain score, easiness of the procedure, procedure time, complications
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female patient pre- or postmenopausal undergo office hysteroscopy.
- •Age: from 20 to
- •BMI between 18 and 30.
排除标准
- •Heavy uterine bleeding
- •Cervical malignancy.
- •Symptoms suggestive of endometriosis .
- •Any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.
研究组 & 干预措施
Misoprostol vaginally, 200 ug
Active Comparator
200 ug misoprostol in the posterior vaginal fornix
干预措施: Misoprostol (Drug)
Misoprostol vaginally, 400ug
Active Comparator
Misoprostol in the posterior vaginal fornix
干预措施: Misoprostol (Drug)
结局指标
主要结局
Pain score
时间窗: 1year
Pain score by VAS
次要结局
- Easiness(1year)
- Duration of the procedure(1year)
研究者
Waleed El-khayat
Assistant professor of obstetrics and gynecology
Cairo University
研究点 (1)
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