Value of Mifepristone in Eliminating the Need for a Second Set of Osmotic Dilators Prior to Dilation and Evacuation Between 19-24 Weeks: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Total Procedure Time
研究概览
简要总结
A common practice for preparation for surgical abortion after 19 weeks gestation is the placement of multiple sets of osmostic dilators 1-2 days prior to the procedure. The investigators aim to study the addition of mifepristone as an adjunct to cervical dilation prior to abortion between 19-24 weeks gestation, and its potential to minimize the number of painful procedures and time in clinic (or away from work/home) that multiple sets of dilators can require. The investigators hypothesize that one set of dilators with mifepristone will result in similar procedure times and decreased "total" time as two sets of dilators.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •>18 years old
- •Viable, Singleton pregnancy
- •Voluntarily seeking abortion between 19 and 24wks gestation
- •Able to give informed consent and comply with study protocol
- •Fluent in English or Spanish
排除标准
- •Allergy to misoprostol or mifepristone
研究组 & 干预措施
Two sets of dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
干预措施: Hygroscopic cervical dilators (Other)
Two sets of dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
干预措施: Misoprostol (Drug)
Two sets of dilators
Two sets of osmotic dilators inserted 1 and 2 days pre-op
干预措施: Intra-amniotic digoxin (Drug)
Mifepristone plus one set of dilators
One set of dilators plus mifepristone
干预措施: Mifepristone (Drug)
Mifepristone plus one set of dilators
One set of dilators plus mifepristone
干预措施: Hygroscopic cervical dilators (Other)
Mifepristone plus one set of dilators
One set of dilators plus mifepristone
干预措施: Misoprostol (Drug)
Mifepristone plus one set of dilators
One set of dilators plus mifepristone
干预措施: Intra-amniotic digoxin (Drug)
结局指标
主要结局
Total Procedure Time
时间窗: Measured at clinic visits and on OR day, over a 3 day period
Procedure Time
时间窗: Intraoperative Time
Measured as time from speculum insertion to removal
次要结局
- Adverse Events (EBL)(Intraoperatively)
- Overall Patient Experience(Measured post operatively (at least 30 minutes, on average 1.5 hours) prior to discharge)
- Ease of Procedure by Blinded Surgeon(Measured Immediately after procedure)
- Maximum Cervical Dilation(Measured intra-operatively)
- Pain Perceived by Patient(Measured pre-operatively (after misoprostol, immediately before transport to OR) and post-operatively (in recovery room, on average 1.5 hours post-operatively))
- Adverse Events(Intraoperatively and 2 weeks post operatively)