Pilot Study of the Addition of Osmotic Dilators to Preparation Prior to Labor Induction Abortion
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Length of Medical Abortion
研究概览
简要总结
One the day prior to medical abortion (labor induction) in the second trimester, insertion of osmotic dilators is added to the routine procedures. The study is to see whether the addition of dilators decreases the abortion time (time for the pregnancy to be expelled)
详细描述
This is a pilot study and is an uncontrolled, non-randomized series. Women having a medical abortion in second trimester undergo several procedures the day before the medication to cause contractions occurs. On the day before admission, they take mifepristone orally, and have a feticidal injection. to this would be added the insertion of cervical osmotic dilators (the intervention). On the day of induction, the dilators would be removed and misoprostol started to cause contractions. We are hoping the median abortion time will drop from the present 9-10 hours to 4-6 hours. women who do not abort in 6 hours will have option of surgical completion of the abortion (dilation and evacuation) if medically appropriate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Requesting abortion 19-23 weeks
- •No contraindication to induction abortion
排除标准
- •Fetal demise
- •Ruptured membranes
- •Evidence of pelvic infection
- •Inability to give informed consent
结局指标
主要结局
Length of Medical Abortion
时间窗: hours since the start of medical abortion
This is the time elapsed from the first dose of misoprostol (the agent to induce abortion) and expulsion of the fetus
次要结局
未报告次要终点