Vertical Splitting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury
2021年1月16日 更新者：Ahmed Abass、Ain Shams University
Comparison Between Vertical Splitting Versus Transverse Cutting of Muscle Layer in Lower Segment Cesarean Sections to Avoid Uterine Vessels Injury: a Randomized Controlled Trial
Cesarean section is one of the oldest surgical interventions in the history of medicine.Many variations in cesarean section technique have been studied.The investigatory team are aiming to decrease blood loss during cesarean section by vertical splitting versus transverse cutting of muscle layer in lower segment cesarean sections to avoid uterine vessels injury.
研究概览
详细说明
Cesarean section is one of the oldest surgical interventions in the history of medicine.Since the first documented cesarean delivery in 1020 AD, various modifications have been made in the technique. It was a surgery performed as a last resort, mostly peri- or post-portem.
Many variations in cesarean section technique have been studied.our study aim is to decrease blood loss during cesarean section through decreasing incidence of uterine vessels injury. The investigator supposed that applying Vertical pull on a small C-shaped incision in the lower uterine segment during cesarean section allows the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
研究类型
介入性
注册 (预期的)
400
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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Cairo、埃及、11311
- Ahmed Abass
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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
18年 至 35年 (成人)
接受健康志愿者
是的
有资格学习的性别
女性
描述
Inclusion Criteria:
- Elective cesarean section
- No medical disorders during pregnancy ( Hypertension, DM , ..)
- No coagulation disorders either congenital nor acquired.
Exclusion Criteria:
- Urgent or emergency cesarean section.
- Multiple pregnancy.
- Presence of medical disorders during pregnancy ( Hypertension, DM , ..)
- Presence of coagulation disorders either congenital nor acquired.
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：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Transverse splitting
transverse cutting and/or pulling of lower uterine segment during lower segment cesarean section.
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Transverse cutting and/or pulling.of
lower uterine segment during lower cesarean section extending the uterine incision laterally.
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有源比较器：Vertical splitting
vertical splitting,of lower uterine segment during lower segment cesarean section.
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vertical splitting of lower uterine segment during lower cesarean section making the direction of traction up and downward instead of being laterally and we suppose that this will allow the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
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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 |
|---|---|---|
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Uterine vessels injury
大体时间：1 minute after extraction of the baby and placenta
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the surgeon performing the cesarean section will detect if injury of uterine vessels occurred or not while extending uterine incision.
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1 minute after extraction of the baby and placenta
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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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uterine incision extension
大体时间：2 minutes extraction of the baby and placenta
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the surgeon performing the cesarean section will detect if uterine incision extension occurred or not after extraction of the baby and the placenta.
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2 minutes extraction of the baby and placenta
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intra-operative blood loss
大体时间：before closure of the abdominal wall layer
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blood loss will be assessed by circulating nurse through counting soaked surgical towels and gauze and calculating estimated blood loss in vacation suction system.
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before closure of the abdominal wall layer
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postpartum hemorrhage
大体时间：first 24 hours after delivery
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will be defined by postpartum blood loss of 1000cc
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first 24 hours after delivery
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postoperative pain
大体时间：2 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain after delivery
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2 hours after delivery
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postoperative pain
大体时间：6 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
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6 hours after delivery
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postoperative pain
大体时间：12 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
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12 hours after delivery
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postoperative pain
大体时间：24 hours after delivery
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pain scale from 0 to 10 to assess postoperative pain at hours 2 after delivery
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24 hours after delivery
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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
- 研究主任：Waled Hitler, Prof、Ainshams university
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)
2021年1月1日
初级完成 (预期的)
2021年12月1日
研究完成 (预期的)
2021年12月1日
研究注册日期
首次提交
2017年7月15日
首先提交符合 QC 标准的
2017年7月18日
首次发布 (实际的)
2017年7月21日
研究记录更新
最后更新发布 (实际的)
2021年1月20日
上次提交的符合 QC 标准的更新
2021年1月16日
最后验证
2021年1月1日
更多信息
与本研究相关的术语
其他研究编号
- Vertical splitting in CS
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
Transverse cutting的临床试验
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Caritasklinik St. Theresia未知