Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol
A Factorial-Design Randomized Controlled Trial Comparing Misoprostol Alone to Dilapan With Misoprostol and Comparing Buccal to Vaginal Misoprostol for Same-Day Cervical Preparation Prior to Dilation & Evacuation
研究概览
地位
详细说明
The primary objective of the study is to compare the efficacy of same-day 400-mcg misoprostol alone to same-day Dilapan with 400-mcg misoprostol for cervical preparation prior to D&E at 14 0/7 to 19 6/7 weeks. Patients will first be randomized to misoprostol alone or misoprostol-Dilapan, and then separately randomized to use the misoprostol buccally or vaginally.
The primary outcome measure is total procedure time. Secondary outcomes include D&E procedure time, initial cervical dilation (measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure), patient-oriented outcomes (side effects of buccal and vaginal misoprostol), and patient acceptability and satisfaction.
The investigators have chosen a randomized controlled trial with a factorial design to be conducted at Washington Hospital Center and Planned Parenthood of Metropolitan Washington. A total up to 180 English speaking women will be enrolled in the study so that 160 will be randomized and receive study interventions. The study will enroll healthy women, over the age of 18, eligible for non-urgent D&E at 14 0/7 weeks to 19 6/7 weeks, confirmed by sonogram. The women will be randomized to receive either misoprostol alone or Dilapan with misoprostol. Women will then be randomized to receive 400-mcg of misoprostol either buccally or vaginally. Computer generated randomization will be utilized to assign treatment arms. Approximately 4-6 hours prior to procedure, women will be randomly assigned to one of the following treatment combinations:
- Misoprostol 400-mcg vaginally
- Misoprostol 400-mcg buccally
- Dilapan insertion with 400-mcg misoprostol vaginally
- Dilapan insertion with 400-mcg misoprostol buccally
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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District of Columbia
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Washington, D.C.、District of Columbia、美国、20010
- MedStar Washington Hospital Center
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Maryland
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Silver Spring、Maryland、美国、20910
- Planned Parenthood Metropolitan Washington
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy pregnant women
- 18 years of age or older
- Eligible for non-urgent Dilation and Evacuations at 14 0/7 - 19 6/7 weeks gestation confirmed by sonogram.
Exclusion Criteria:
- Women who do not speak English.
- Fetal demise
- Intolerance, allergy or contraindication to misoprostol or Dilapan.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:阶乘赋值
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Misoprostol Alone
Subjects enrolled into this arm of the study will receive misoprostol 400-mcg only.
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实验性的:Dilapan with Misoprostol
Subjects enrolled into this arm of the study will receive Dilapan with 400-mcg misoprostol.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Total procedure time
大体时间:4-6hrs
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Total procedure time is defined as the time required for dilator insertion plus the D&E time.
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4-6hrs
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
D&E procedure time
大体时间:0-60 mins
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0-60 mins
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Initial cervical dilation
大体时间:0-10 mins
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Measured by the largest Hegar dilator accepted without resistance prior to the start of the procedure.
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0-10 mins
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合作者和调查者
调查人员
- 首席研究员:Dr. Matthew Reeves, MD MPH、MedStar Washington Hospital Center & Planned Parenthood of Metropolitan Washington
- 学习椅:Dr. Jamilah Shakir, MD MPH、MedStar Washington Hospital Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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