Comparison of Efficacy of Vaginal Misoprostol versus a Synthetic Osmotic Dilator (Dilapan-S) for Cervical Preparation four hours before Operative Hysteroscopy: A Double Blinded Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To compare the need for mechanical dilatation, following vaginal Misoprostol or synthetic osmotic dilator (Dilapan) for cervical preparation 4hrs prior to operative hysteroscopy.
研究概览
简要总结
Comparison of efficacy of vaginal Misoprostol vs synthetic osmotic dilator Dilapan for cervical preparation four hours prior to operative hysteroscopy A Double blinded randomized controlled study.
Primary outcome is to compare the need for mechanical dilatation, following vaginal Misoprostol or synthetic osmotic dilator (Dilapan) for cervical preparation4hrs prior to operative hysteroscopy
Synthetic osmotic dilators may be more effective in achieving optimal cervical dilatation before operative hysteroscopy as compared to prostaglandin analogues like misoprostol. Usually osmotic dilators are instilled for 12hours. Instillation of cervical dilators for 12 hours is not convenient as these procedures are usually done as day care procedures. Instillation of osmotic dilators for shorter duration 4h may also be effective.
There are only few studies, which have compared a synthetic osmotic dilator with Misoprostol for cervical dilatation 12 hours before operative hysteroscopy. However, there is no published study comparing the efficacy of Misoprostol and 4 mm Dilapan for 4 hours in cervical preparation in a non-gravid uterus. This study addresses this gap.
If proven superior to Misoprostol short term Dilapan S could be used routinely for cervical preparation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Women of age 18 years or more, scheduled for operative hysteroscopic procedures with 26F resectoscope.
排除标准
- •Known Cervical incompetence ii.
- •Contraindication to Misoprostol use like history of severe asthma, glaucoma, preexisting cardiac disease, hypertension, or renal failure iii.
- •Significant uterovaginal prolapse precluding the administration of vaginal tablets.
- •Active vaginal infection or active pelvic inflammatory disease.
结局指标
主要结局
To compare the need for mechanical dilatation, following vaginal Misoprostol or synthetic osmotic dilator (Dilapan) for cervical preparation 4hrs prior to operative hysteroscopy.
时间窗: During the insertion of 26 F resectoscope-operative hysteroscope | AT 4 HOURS - following vaginal misoprostol or synthetic osmotic dilator dilapan S
次要结局
- To study the side effects & complications of Misoprostol & short term use of synthetic osmotic dilator (Dilapan).(during 4 HOURS The time period after inserting the drug or medical device to before shifting the patient to the operation theatre)
研究者
Shyma Madniya
Jawaharlal Institute of Postgraduate Medical Education And Research