Mifepristone vs. Laminaria Insertion for Cervical Preparation Prior to Surgical Abortion at 14-16 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time for Completion of Procedure
研究概览
简要总结
Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before the procedure.
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-45 having pregnancy termination at 14-16 weeks
排除标准
- •multiple gestation, pre-existing infection, contraindication to osmotic dilators, unable to obtain proper consent
研究组 & 干预措施
mifepristone
women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed.
干预措施: mifepristone 200 mg (Drug)
Osmotic dilator insertion
Women assigned to this arm would have the standard procedure for cervical preparation, which is insertion of osmotic dilators the day before the abortion procedure
干预措施: osmotic dilator insertion (Device)
结局指标
主要结局
Time for Completion of Procedure
时间窗: Performance and completion of the abortion procedure takes 10-20 minutes. The length of the procedure is measured. The procedure occurs approximately 24 hours after enrollment.
Minutes, from the time of the start of the procedure (speculum insertion) to the conclusion of the procedure (speculum removal)
次要结局
- Assessment of Ease of Procedure by Operator(It is administered shortly after the primary outcome, which is one day after enrollment. The study is complete at that point.)
- Moderate or Severe Pain Overnight(Overnight)
研究者
Lynn Borgatta
Principal investigator
Boston University