A Randomized Controlled Trial of Standard Tubal Ligation Versus Salpingectomy for Sterilization at the Time of Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Time of tubal ligation
研究概览
简要总结
The objective of this study is to evaluate the feasibility and safety of salpingectomy versus standard tubal ligation in women undergoing surgical sterilization at the time of a planned cesarean delivery. Salpingectomy is currently being investigated as a potential strategy for ovarian cancer prevention. While this procedure is currently performed during hysterectomies, its feasibility at the time of cesarean delivery is not well established.
This randomized, prospective clinical trial will compare the two sterilization methods to demonstrate that salpingectomy compared with standard tubal ligation at the time of cesarean delivery will not result in increased operative time, blood loss or other complications. This study is necessary to promote salpingectomy as a standard sterilization method during cesarean deliveries.
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
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects must have planned cesarean delivery and desire sterilization
- •Subjects must be able to read and provide written informed consent
- •Subjects must be English or Spanish speaking
排除标准
- •Subjects with known hereditary cancer syndromes
- •Subjects with a history of prior tubal surgery
- •Subjects with a placenta accreta
- •Subjects undergoing trial of labor after cesarean delivery
研究组 & 干预措施
Control
Tubal sterilization will be performed by standard tubal ligation, either Parkland or Pomeroy technique, at the time of cesarean section
干预措施: Tubal ligation (Procedure)
Experimental
Tubal sterilization will be performed by bilateral salpingectomy using a ligasure device at the time of cesarean section.
干预措施: Salpingectomy (Procedure)
结局指标
主要结局
Time of tubal ligation
时间窗: at time of procedure
Primary outcome will be the time it takes to complete the sterilization procedure
次要结局
- Total procedure time(at time of procedure)
- Estimated blood loss(at time of procedure)
- Rate of aborted procedures(at time of procedure)
研究者
Kate Pettit, MD
Assistant Professor, Division of Maternal Fetal Medicine
University of Virginia