Cervical Priming With Misoprostol Before Diagnostic Office Hysteroscopy in Patients With no Risk Factors for Experiencing Unacceptable Pain. A Randomized Double Blinded Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.
详细描述
Cervical ripening with misoprostol to minimize the pain experienced during office hysteroscopy has been proposed by several authors.
The use of misoprostol is usually associated with undesired side effects and therefore any beneficial effect of misoprostol on reducing pain should be weighed against its undesired side effects (nausea, vomiting, diarrhea, fever, shivering, pain) and coasts. Till now , no studies have yet determined whether misoprostol should be used routinely or for the subgroup of patients at higher risk for cervical stenosis.
The aim of this study is to assess whether vaginal misoprostol reduces pain during office hysteroscopy in parous patients with no risk factors for experiencing severe or unacceptable pain.
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Patients with at least one vaginal delivery who have an indication for office hysteroscopy.
排除标准
- •Nulliparous patients, menopausal patients and patients with cervical pathology, and previous history of caesarean 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)
Placebo
Placebo is administered vaginally 12 hours before office hysteroscopy
干预措施: Placebo (Drug)
结局指标
主要结局
Intensity of pain
时间窗: procedure
次要结局
- Operative time(procedure)