Comparing Effectiveness of Oral Misoprostal for Cervical Priming in Premenopausal Women Underwent to Diagnostic Hysteroscopy: Double-blind, Randomized Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- initial cervical diameter
研究概览
简要总结
Research objective To compare effectiveness of oral Misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy Research hypothesis: Null hypothesis Effectiveness of oral misoprostal for cervical priming in premenopausal women underwent to diagnostic hysteroscopy is not different from placebo Alternative hypothesis: : Oral Misoprostal for cervical priming in Premenopausal women underwent to diagnostic hysteroscopy is better than placebo
详细描述
Research design Randomized double-blinded placebo-controlled trial. The investigators who assess the outcomes and the participants do not know Misoprostal group or control group. The patients are given the random concealed envelop which contains Misoprostal or placebo to take before hysteroscopy. Surgeon and the investigator whom assess patients do not know group allocation.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women
- •Patients have following indication for diagnosis hysteroscopy
- •Abnormal uterine bleeding
- •Unexplained infertility
- •Recurrent pregnancy loss
- •Chronic pelvic pain
- •Late postpartum hemorrhage
- •Patients provided written informed consent
排除标准
- •Postmenopausal women
- •Patients who have contraindication for Misoprostal as following
- •Allergic to Misoprostal
- •Medical illnesses such as cardiovascular diseases, Asthma, Renal disease
- •Patients who have contraindication for Hysteroscopoy as following
- •Pregnant women
- •Pelvic inflammatory disease
- •Infection at cervix and vagina
- •Cervical cancer
研究组 & 干预措施
Misoprostal group
Patients were added oral Misoprostal 200 mcg 2 tab per oral 3 hour before hysteroscopy
干预措施: Misoprostol 200Mcg Tab (Drug)
结局指标
主要结局
initial cervical diameter
时间窗: 1 year
The initial hedgar dilator number which can easily insert through cervix
次要结局
未报告次要终点