NCT00835731已完成不适用
Cervical Preparation Before Same-day Second Trimester Abortion With Buccal Misoprostol Versus Dilapan-S: A Randomized Placebo Controlled Trial
Planned Parenthood League of Massachusetts1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2009年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Cervical Dilation in Women Following Exposure to Either Ripening Agent
研究概览
简要总结
The purpose of this study is to compare the dilatory effect of 400 mcg of buccally administered misoprostol to one Dilapan-S rod placed 3-4 hours before abortion by dilation and evacuation in women who are 12 weeks 0 days to 15 weeks 0 days gestation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •medically eligible for dilation and evacuation at Planned Parenthood League of Massachusetts
- •gestational age 12 weeks 0 days to 15 weeks 0 days as evaluated by ultrasound
- •proficient in English or Spanish
- •agreeing to study procedures, including randomization and surveys regarding demographics, medical and gynecological history, and assessments of pain and satisfaction
排除标准
- •less than 18 years old
- •cervical or uterine anomaly that the research physician deems may affect the difficulty of dilation or the abortion procedure
- •inflammatory bowel disease
- •contraindication to misoprostol use
- •known intolerance or allergy to misoprostol or Dilapan-S
- •inability to give informed consent
研究组 & 干预措施
1
Experimental
400mcg buccal misoprostol
干预措施: misoprostol (Drug)
2
Experimental
Dilapan-S, control: vitamin B-12 administered sublingually
干预措施: Dilapan-S, vitamin B-12 (Device)
结局指标
主要结局
Cervical Dilation in Women Following Exposure to Either Ripening Agent
时间窗: 3-4 hours after placement of ripening agent
次要结局
- Procedure Time for Dilation and Evacuation(3-4 hours after placement of ripening agent)
- Subject Pain During Ripening(3-4 hours after placement of ripening agent)
- Women's Satisfaction With Cervical Ripening Method(5 hours after placement of ripening agent)
- Ease of Further Mechanical Dilation in Women Following Exposure to Either Ripening Agent, as Per MD Report(3-4 hours after placement of ripening agent)
- Subject Pain During Dilation and Evacuation(3-4 hours after placement of ripening agent)
- Number of Patients for Whom Physician Was Able to Complete Dilation and Evacuation Procedure on First Attempt(3-4 hours after placement of ripening agent)
研究者
研究点 (1)
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