Salpingectomy at Cesarean Delivery for Ovarian Cancer Reduction (SCORE) (SCORE)
2017年10月3日 更新者：Akila Subramaniam, MD、University of Alabama at Birmingham
Complete Salpingectomy Versus Standard Postpartum Tubal Ligation at the Time of Cesarean Delivery- a Randomized Controlled Study
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Alabama
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Birmingham、Alabama、美国、35249
- University of Alabama at Birmingham
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
25年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：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.
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Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
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实验性的：Complete Salpingectomy
In this arm, patients will receive a complete salpingectomy by documented accepted methods.
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Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to complete sterilization procedure
大体时间：At time of procedure
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The primary outcome will involve measuring the amount of surgical time required to complete the assigned sterilization procedure
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At time of procedure
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Completion rate of sterilization procedure
大体时间：At time of procedure
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The primary outcome will involve assessing the completion rate of assigned sterilization procedure
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At time of procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Total operative time
大体时间：At time of procedure
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Includes cesarean delivery and sterilization procedure time
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At time of procedure
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Mean post-operative pain score
大体时间：Postpartum admission (3-4 days)
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Postpartum admission (3-4 days)
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Perioperative complication rate
大体时间：From time of procedure to 6 weeks postpartum
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Composite assessment of the following: estimated blood loss, need for blood transfusion, intra-abdominal hemorrhage/hematoma, need for readmission, need for reoperation, need for additional surgical procedure, major post-operative complication
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From time of procedure to 6 weeks postpartum
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Akila Subramaniam, MD, MPH、University of Alabama at Birmingham
- 首席研究员：Britt K Erickson, MD、University of Alabama at Birmingham
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Subramaniam A, Einerson BD, Blanchard CT, Erickson BK, Szychowski J, Leath CA 3rd, Biggio JR, Huh WK. The cost-effectiveness of opportunistic salpingectomy versus standard tubal ligation at the time of cesarean delivery for ovarian cancer risk reduction. Gynecol Oncol. 2019 Jan;152(1):127-132. doi: 10.1016/j.ygyno.2018.11.009. Epub 2018 Nov 23.
- Subramaniam A, Blanchard CT, Erickson BK, Szychowski J, Leath CA, Biggio JR, Huh WK. Feasibility of Complete Salpingectomy Compared With Standard Postpartum Tubal Ligation at Cesarean Delivery: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):20-27. doi: 10.1097/AOG.0000000000002646.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年4月1日
初级完成 (实际的)
2017年4月1日
研究完成 (实际的)
2017年9月1日
研究注册日期
首次提交
2015年2月23日
首先提交符合 QC 标准的
2015年2月23日
首次发布 (估计)
2015年3月2日
研究记录更新
最后更新发布 (实际的)
2017年10月5日
上次提交的符合 QC 标准的更新
2017年10月3日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.