Cervical Ripening in Postmenopausal Women: A Randomized, Double Blind, Placebo Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Efficacy (Cervical Ripening)
研究概览
简要总结
Misoprostol (Cytotec) 200ug vaginally will be given to patients 12 hours and 2 hours pre-operatively (before surgery) for a total of 400ug to ripen, soften or relax the cervix for dilation (opening). This is to assist with the insertion of a hysteroscope (the surgical instrument) into the uterus for all operative hysteroscopic procedures requiring dilation above 5 mm.
Time required for cervical dilatation will be recorded. Start time will be when the smallest dilator is placed into the endocervical canal, and stop time recorded when the desired cervical dilation is achieved with the largest dilator. Depending on the procedure, desired dilation may range between 5-10mm. Time will serve as a surrogate for operative ease of dilatation.
The investigators will compare the two groups in terms of medication, resistance, dilation time and size, side effects and surgical complications.
详细描述
This study will be a randomized, double blinded, placebo controlled trial.
Patients will be assigned by chance to receive 200ug of misoprostol or placebo (empty gelatin capsule) vaginally twice (for a total of 400ug). There is no standard of care, but to receive misoprostol or not are both accepted practices and that Standard of Care is for the clinicians to use clinical judgment .
Patients will be randomized to one of the following treatment regimens:
Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol). St. Mary's pharmacy will prepare capsules with each containing 200ug of misoprostol.
Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.
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
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •45-80yrs of age
- •Postmenopausal (amenorrhea for greater than 1 year)
- •May or may not be using hormone replacement therapy
- •Scheduled or to be scheduled for hysteroscopy/resectoscopy procedures
排除标准
- •Known Cancer
- •Known hypersensitivity to prostaglandins.
- •Those who are breastfeeding
研究组 & 干预措施
Group 1
Group 1 will received 200ug of misoprostol, to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery (a total of 400ug of misoprostol).
干预措施: Misoprostol (Drug)
Group 2
Group 2 will received placebo (empty gelatin capsule), to be placed into the posterior vaginal fornix 12 hours and 2 hours before their scheduled surgery.
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy (Cervical Ripening)
时间窗: At time of surgery/cervical dilation
To evaluate the efficacy of two doses of 200ug of misoprostol (for a total of 400ug), administered vaginally, on cervical ripening before diagnostic and operative hysteroscopic procedures in postmenopausal women (amenorrhea greater than 1 year). Efficacy is represented by time to dilation.
次要结局
- Maximum Dilator Size(At time of procedure.)
- Number of Recorded Side Effects.(At time of surgery/cervical dilation)
- Dilation Time in Minutes(At time of procedure.)
- Number of Complications(At time of procedure.)
- Resistance Score(At time of procedure.)
研究者
Donald Gregory Ward, M.D.
MD
St. Louis University