Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle
研究概览
简要总结
The purpose of this study is to determine whether using Misoprostol vaginally before an office endometrial biopsy is performed, will make it easier, more successful and less painful to do the procedure.
The investigators' hypothesis is that vaginal Misoprostol 12 hours prior to endometrial biopsy will increase the ease of performing office endometrial biopsy by reducing the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle.
详细描述
Endometrial biopsy is a common gynecological office procedure performed to assist in the pathological diagnosis of abnormal vaginal bleeding. The procedure can be painful and it may be difficult to obtain an endometrial sample with a hard and closed cervix. Giving Misoprostol before the procedure may soften the cervix sufficiently to allow an easier and more successful test. This medication has been tested before hysteroscopy and in some patients it has been shown to be beneficial.
104 patients need to be recruited for this study. Participants will be divided according to pre-menopausal and post-menopausal status. Each of these groups will then be divided into a treatment arm (with Misoprostol) and a placebo arm. Participants will place a vaginal suppository containing either Misoprostol 400 ug or a placebo 12h or more before their appointment for the endometrial biopsy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with abnormal uterine bleeding
- •Age over 35 years
排除标准
- •Pregnancy
- •Allergy to or contraindication to prostaglandin use
- •Active genital tract infections
- •Bleeding disorders
研究组 & 干预措施
Pre-Menopausal 1
Pre-Menopausal group, receiving Misoprostol
干预措施: Misoprostol (Drug)
Pre-Menopausal 2
Patients will insert a placebo vaginal suppository 12h or more prior to the endometrial biopsy
干预措施: Placebo (Drug)
Post-Menopausal 1
Post-Menopausal patients will insert a Misoprostol vaginal suppository 12h or more prior to the endometrial biopsy
干预措施: Misoprostol (Drug)
Post-Menopausal 2
Placebo vaginal suppository prior to the endometrial biopsy
干预措施: Placebo (Drug)
结局指标
主要结局
Evaluating the ease of an endometrial biopsy by the need to use a tenaculum or a cervical dilator to achieve passage of a biopsy pipelle
时间窗: 1 year
次要结局
- Evaluating participants discomfort during the procedure, using a pain scale(1 year)
- Success rate of passage of the pipelle(1 year)
- Adverse effects from medications(1 year)
- Complications of the procedure(1 year)
研究者
Anita Harding
Dr.
University of Saskatchewan