Same-day Cervical Preparation With Dilapan-S™ Plus Buccal Misoprostol Compared to Overnight Dilapan-S™ Before Dilation and Evacuation at 16 to 20 Weeks' Gestation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
The purpose of this randomized trial is to compare same-day cervical preparation using Dilapan-S™ plus buccal misoprostol to overnight cervical preparation using Dilapan-S™ before D&E at 16.0 to 20.0 weeks.
Primary objective: To compare D&E operative time. We hypothesize that same-day Dilapan-S™ plus buccal misoprostol is non-inferior to overnight Dilapan-S™ with respect to operative time.
Secondary objectives: To compare treatment groups for the following: Pre-operative cervical dilation; need for mechanical dilation and ease of dilation if required; ability to complete D&E without further cervical preparation; ease of D&E; complications; pain; side effects; patient and provider satisfaction.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older
- •Seeking pregnancy termination from 16 0/7 to 19 6/7 weeks of gestation on the day of enrollment.
- •Eligible for pregnancy termination at PPNYC
- •Able to give informed consent
- •English speaking
排除标准
- •Active bleeding or hemodynamically unstable at enrollment
- •Signs of chorioamnionitis or clinical infection at enrollment
- •Signs of spontaneous labor or cervical insufficiency at enrollment
- •Spontaneous intrauterine fetal demise
- •Allergy to Dilapan-S™ or misoprostol
结局指标
主要结局
Operative time
时间窗: From initiation of D&E procedure to completion of D&E procedure, Study Day 2
次要结局
未报告次要终点