Same-day Dilapan Versus Overnight Laminaria for Cervical Preparation for Early Second-trimester Surgical Abortion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Procedure Time
研究概览
简要总结
This is a randomized, blinded clinical trial comparing overnight laminaria versus same-day Dilapan for cervical preparation for surgical abortions occurring between fourteen and eighteen weeks gestation. Comparisons will be made between procedure time, need for additional dilation, occurrence of complications, and patient and provider satisfaction.
Hypothesis:
Cervical preparation for surgical abortion, between fourteen and eighteen weeks gestation, with same-day Dilapan is non-inferior to cervical preparation with overnight laminaria within a five-minute difference.
Primary objective:
Determine differences in procedure times
Secondary objectives:
Examine complications, and need for additional dilation between early second-trimester surgical abortions performed after cervical preparation with same-day Dilapan versus those performed after cervical preparation with overnight laminaria
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, Investigator, 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
- 是
入选标准
- •Pregnancy between fourteen and eighteen weeks gestation
- •Request for elective abortion and certainty of decision to proceed
排除标准
- •Incarceration
- •Minor status (women younger than eighteen years)
- •Allergy to Dilapan or laminaria
- •Inability to speak and understand Spanish or English
研究组 & 干预措施
laminaria
laminaria placed for cervical dilation; usual standard of care in study clinic
干预措施: laminaria (Device)
Dilapan-S
experimental treatment
干预措施: Dilapan-S (Device)
结局指标
主要结局
Procedure Time
时间窗: Day of procedure
Procedure time to complete early second-trimester dilation and evacuation (D\&E)
次要结局
- Participants Who Experienced Complications or Need for Additional Dilation(Day of procedure)
研究者
Eleanor Drey, MD
Associate Professor
University of California, San Francisco