Laminaria Compared to Dilapan-S for Cervical Preparation Before Dilation and Evacuation at 18-24 Weeks of 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
- 180
- 试验地点
- 2
- 主要终点
- D&E Procedure Time
研究概览
简要总结
Primary objective: To study the difference in dilation and evacuation (D&E) procedure time following overnight cervical preparation with laminaria or Dilapan-S™. The investigators hypothesize procedure time will be less with Dilapan-S™.
Secondary objectives: To compare the use of laminaria and Dilapan-S™ for differences in: (1) initial cervical dilation before D&E; (2) need for mechanical dilation to accomplish D&E and ease of dilation if required; (3) number of osmotic dilators placed; (4) ability to complete the D&E procedure without further cervical preparation; (5) complications; (6) pain and other side effects; (7) patient acceptability; and (8) provider acceptability.
详细描述
One hundred eighty women were randomized evenly across treatment arms, stratified by gestational age groups of 18 0/7-20 6/7 (n= 91) and 21 0/7-24 0/7 (n=87). The analytic sample N=173 (laminaria=86, Dilapan=87); 2 cases were removed for post-randomization exclusion and 5 for missing data on one or more outcome variables. Demographic information and results for the primary outcome of procedure time are reported below in tabular form in the results section.
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 18 0/7 to 24 0/7 weeks of gestation
- •Eligible for pregnancy termination at Planned Parenthood of New York City
- •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 laminaria or Dilapan-S™
结局指标
主要结局
D&E Procedure Time
时间窗: The primary outcome measure will be assessed on the day of the patient's D&E procedure. (day 2)
Length of D\&E procedure in minutes
次要结局
未报告次要终点