NCT05099991已完成不适用
Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion: a Non-Inferiority Randomized Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Procedure Time
研究概览
简要总结
The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •presenting to clinic for second trimester abortion at 18 to 23 weeks and 6 days gestation confirmed by ultrasound
- •able to provide informed consent and comply with study protocol
- •English or Spanish-speaking
- •candidate for outpatient cervical preparation
排除标准
- •Anyone with an allergy to misoprostol, mifepristone or any study medication
- •premature rupture of membranes
- •intrauterine fetal demise
- •placenta previa
- •suspected abnormal placentation
- •evidence of infection at the time of enrollment
结局指标
主要结局
Procedure Time
时间窗: Up to approximately 30 minutes
Time to speculum in to speculum out
次要结局
- Cervical Dilation(Beginning of the procedure (approximately 5 seconds to assess))
研究者
研究点 (2)
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