Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Time to complete sterilization procedure
研究概览
简要总结
To compare the feasibility and surgical outcomes between complete salpingectomy and standard postpartum tubal ligation (partial salpingectomy) at the time of cesarean delivery in women with undesired future fertility. as a possible ovarian cancer risk-reducing procedure.
详细描述
All pregnant women receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat) will be approached about the study. Patients will be randomized to receive either the standard tubal ligation practice at our institution (modified Pomeroy procedure or Parkland) or a complete salpingectomy. The objective of this trial is to evaluate if a complete salpingectomy can be performed safely and comparable to a standard postpartum tubal ligation.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All pregnant women > 25 years receiving prenatal care within the UAB Health System, and planning to undergo tubal ligation at the time of their scheduled cesarean delivery (primary or repeat)
- •Informed consent obtained
排除标准
- •Inability to obtain informed consent
- •Fetal death or anomalies
- •Preterm delivery < 36 weeks gestation
- •Immune-compromising disease
- •Chronic steroid use
- •Chronic prophylactic or therapeutic anti-coagulation
- •Patients no followed in our regional health system
- •Known BRCA mutation carrier status
- •Age < 25 years
研究组 & 干预措施
Standard postpartum tubal ligation
In this arm, patients will receive the standard postpartum tubal ligation by accepted methods (procedure names are the following: Modified pomeroy technique or Parkland method). These methods are procedures for completing a partial salpingectomy.
干预措施: Standard postpartum tubal ligation (Procedure)
Complete Salpingectomy
In this arm, patients will receive a complete salpingectomy by documented accepted methods.
干预措施: Complete Salpingectomy (Procedure)
结局指标
主要结局
Time to complete sterilization procedure
时间窗: At time of procedure
The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure
Completion rate of sterilization procedure
时间窗: At time of procedure
The primary outcome will involve assessing the completion rate of assigned sterilization procedure
次要结局
- Total operative time(At time of procedure)
- Mean post-operative pain score(Postpartum admission (3-4 days))
- Perioperative complication rate(From time of procedure to 6 weeks postpartum)
研究者
Akila Subramaniam, MD
Maternal-Fetal Medicine Fellow
University of Alabama at Birmingham