NCT02165709已完成不适用
Cohort Study of Risk Reducing Salpingectomy (RRS) Versus Standard Tubal Sterilization Among Women Who Desire Sterilization
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percent of women accepting RRS
研究概览
简要总结
Women undergoing surgical sterilization will be interested in risk reducing salpingectomy, and surgeons performing the procedure will be able to successfully complete the salpingectomy.
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
- 35 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women > 35 years requesting sterilization as interval procedure OR at time of cesarean delivery
- •At least one living child
- •English or Spanish speaking
- •Sterilization planned as interval (laparoscopic) procedure via Family Planning Clinic services or at time of delivery
- •Delivery by cesarean section (planned or following labor)
排除标准
- •Age < 30
- •Medical complications that increase risk for surgical bleeding (e.g. Idiopathic thrombocytopenic purpura (ITP); von Willebrand disease (vWD); need for prophylactic or therapeutic anticoagulation)
研究组 & 干预措施
Salpingectomy
Experimental
Participants will be offered a risk-reducing salpingectomy, and if they choose this options the surgeon will proceed with a salpingectomy.
干预措施: Salpingectomy (Procedure)
Traditional sterilization
Active Comparator
Participants will be offered a risk-reducing salpingectomy, and those that choose a traditional sterilization will be in this treatment arm.
干预措施: Traditional sterilization (Procedure)
结局指标
主要结局
Percent of women accepting RRS
时间窗: 12 months
Determination of patient demand/interest in pursuing RRS for sterilization during 12-month study period
次要结局
- Percent of women with successful RRS completion(12 months)
研究者
研究点 (1)
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