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临床试验/NCT06254092
NCT06254092尚未招募不适用

Effect of Tourniquet Binding of Cervical on the Blood Volume of Amniotic Fluid in Cesarean Section

First People's Hospital of Chenzhou1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
28
试验地点
1
主要终点
sTn

研究概览

简要总结

This study was conducted to investigate whether the use of tourniquet after delivery of the fetus could reduce the amount of amniotic fluid entering the bloodstream and thus reduce the incidence of intraoperative adverse events.

详细描述

Amniotic fluid embolism (AFE) is a rare complication specially to obstetrics.When amniotic fluid enters the maternal circulation , a sudden onset of a series of pathophysiologic changes such as pulmonary hypertension, hypoxemia, circulatory failure, disseminated intravascular coagulation, and multiorgan failure may occur. Routinely, the typical AFE triad is uneasy to discover, and nonspecific adverse reactions such as irritability, chills, chest tightness and shortness of breath, transient drop in blood pressure, and nausea and vomiting are often seen during delivery of the fetus and placenta. All of the above symptoms may suggest that the amniotic fluid has entered into the bloodstream. In clinical anesthesia, investigators observed that women with placenta praevia and placenta implantation were less likely to suffer these nonspecific symptoms after delivery of the fetus compared with women with normal pregnancies.The investigators speculated it might be related to the fact that obstetricians used tourniquets to reduce intraoperative hemorrhage in the former, blocking venous return to the lower uterine segments to reduce the inflow of amniotic fluid into the uterus. Therefore, this study was conducted to investigate whether the use of tourniquet after delivery of the fetus could reduce the amount of amniotic fluid entering the bloodstream and thus reduce the incidence of intraoperative adverse events.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Single pregnancy
  • Be in good health, with no high blood pressure or heart disease during pregnancy
  • Without placenta previa and placenta implantation
  • No abdominal adhesions, suitable for operation
  • Signed informed consent by the pregnant woman and her family

排除标准

  • Serious coagulation abnormality
  • Preoperative severe cardiac, cerebral, pulmonary, hepatic, renal and other important organs insufficiency and electrolyte abnormality combined with placenta praevia or placenta implantation
  • Multiple pregnancies
  • Previous history of abdominal surgery
  • Intraoperative drug allergy

结局指标

主要结局

sTn

时间窗: before the fetus is delivered,after the fetus is delivered,before the puerpera is sent back to the ward

sTn refers to meconium and mucin extracted from amniotic fluid. The presence of sTn in the patient's serum is a diagnostic method that can directly prove that mucin derived from amniotic fluid has entered the maternal circulation.

次要结局

  • HR MAP(before the fetus is delivered,after the fetus is delivered,before the placenta is delivered,after the placenta is delivered,after releasing the tourniquet,before the puerpera is sent back to the ward)
  • Adverse events(perioperatively)
  • Hemorrhage(before the puerpera is sent back to the ward, 2 hours after the puerpera back to ward)
  • SPO2,PaO2,PaCO2(before the fetus is delivered,after the fetus is delivered,before the placenta is delivered,after the placenta is delivered,after releasing the tourniquet,before the puerpera is sent back to the ward)
  • Thrombelastogram(TEG)(before the fetus is delivered,before the puerpera is sent back to the ward)

研究者

发起方
First People's Hospital of Chenzhou
申办方类型
Other
责任方
Principal Investigator
主要研究者

zhiming zhang

chief

First People's Hospital of Chenzhou

研究点 (1)

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