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临床试验/NCT04083768
NCT04083768已完成不适用

Effect of Different Left Lateral Table Tilt on Neonatal Acid-base Status and Maternal Hemodynamics for Elective Cesarean Delivery Under Spinal Anesthesia

Xuzhou Medical University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
Umbilical artery blood pH

研究概览

简要总结

The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

详细描述

When the pregnant woman in the third trimester is in the supine position, the enlarged uterus may oppress the inferior vena cava, thereby reducing the amount of blood and heart output of the pregnant woman. This affects the mother mainly, such as dizziness, nausea and vomiting, chills, and severe irritability,difficulty breathing or even cardiac arrest, the impact on the fetus is mainly the reduction of blood flow in the placenta, affecting the blood exchange of the uterus placenta, causing neonatal respiratory distress, acidosis and even death. The recommended position of the mother under caesarean section after spinal anesthesia is 15 degrees left. However, recent research has challenged the basic principles and practicality of the left-turn 15 degree position. Higuchi et al used nuclear magnetic imaging to directly prove that in the supine position, the position of the full-left 30 degrees of the full-term pregnancy of the full-term pregnancy relieved the inferior vena cava compression and the left-angle of 15 degrees did not. Therefore, there are more and more controversies about the choice of cesarean section position. This experiment aims to explore effects of different positions (15 degrees left, 30 degrees left and supine) for elective cesarean section on lumbar anesthesia for fetal acid-base balance and maternal Hemodynamic.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancy at term via elective cesarean section
  • Height from 150 cm to 180 cm
  • American Society of Anesthesiologists (ASA) grade from I to II grade
  • BMI(Body Mass Index,mearsured weight divided by height squared)less than 35 kg/m2.

排除标准

  • Transverse lie
  • Fetal macrosomia
  • Uterine abnormalities (e.g., large fibroids, bicornuate uterus)
  • Polyhydramnios
  • Ruptured membranes
  • Oligohydramnios
  • Intrauterine growth restriction
  • Gestational or nongestational hypertension, diabetes, eclampsia
  • Hypertensive disorder or any condition associated with autonomic neuropathy (e.g., diabetes mellitus for more than 10 yr), with renal failure
  • Have contraindications for spinal anesthesia(Such as low back infection, spinal deformity, etc.)
  • Participants refused to sign informed consent.

结局指标

主要结局

Umbilical artery blood pH

时间窗: Immediately after delivery

Use a blood gas analyzer to measure

次要结局

  • The incidence of nausea in pregnant women(Intraoperative)
  • The incidence of vomiting in pregnant women(Intraoperative)
  • The incidence of bradycardia in pregnant women(Intraoperative)
  • Other UA and UV blood gas analysis values(pH, base excess, lactate , Umbilical artery blood PaCO2(Immediately after delivery)
  • The incidence of hypotension in pregnant women(Intraoperative)
  • The incidence of hypertension in pregnant women(Intraoperative)
  • Dosage of phenylephrine during surgery(Intraoperative)
  • Fetal Apgar score (1 minute after birth) And 5 minutes(One minute and five minutes after the baby is delivered)
  • One min (T1), 3 min (T2), 5 min (T3), 7 min (T4), 9 min (T5), 11 min (T6), 13 min (T7) and 15 min (T8) blood pressure after subarachnoid injection (completion of the subarachnoid injection was defined as 0 time point)(Intraoperative)
  • One min (T1), 3 min (T2), 5 min (T3), 7 min (T4), 9 min (T5), 11 min (T6), 13 min (T7) and 15 min (T8) heart rate after subarachnoid injection (completion of the subarachnoid injection was defined as 0 time point)(Intraoperative)
  • Dosage of ephedrine during surgery(Intraoperative)
  • Dosage of atropine during surgery(Intraoperative)

研究者

发起方
Xuzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chao Xu

Principal Investigator

Xuzhou Medical University

研究点 (1)

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