Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
The study titled, Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 weeks: A Randomized Trial, is a randomized trial to compare procedure times for manual and electric vacuum aspiration for surgical abortion between 10 0/7 and 13 6/7 weeks gestation. Women presenting for surgical abortion between 10 0/7 and 13 6/7 weeks gestation will be randomized to either undergo manual vacuum aspiration (MVA) or electric vacuum aspiration (EVA). The investigators hypothesize that operative times will be increased when using manual vacuum aspiration, as compared to electric vacuum aspiration, for surgical abortion performed in the late first trimester (10 0/7 and-13 6/7 weeks).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Between 10 0/7 and 13 6/7 weeks of gestation
- •Documented intra-uterine pregnancy
- •Presenting for surgical induced abortion at RHS
- •English-speaking
- •Age 18 or older
排除标准
- •Spontaneous abortion
- •Failed medical abortion
- •Multiple gestation
- •Uterine anomalies
- •Lower uterine segment or cervical myomas
- •History of 3 or more prior cesarean deliveries
- •BMI > 40
- •Having the abortion procedure performed by a provider who does not perform MVA and EVA between 10 0/7 and 13 6/7 weeks
结局指标
主要结局
Operative time
时间窗: Perioperative
Time from cannula insertion until completion of uterine evacuation
次要结局
- Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure(Perioperative)
- Provider acceptability(Perioperative)
- Patient acceptability(Perioperative and 2 weeks postoperatively)