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临床试验/NCT03496311
NCT03496311Unknown不适用

Effects of Pregnancy on the Physico-chemical Characteristics of Cerebrospinal Acid-base Equilibrium

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年4月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Strong Ion Difference

研究概览

简要总结

The third trimester of pregnancy is typically characterized by the development of a marked respiratory alkalosis. The possible role of pregnancy-induced variations of cerebrospinal fluid (CSF) acid-base characteristics on the development of hypocapnic alkalosis is still unknown.

Aim of this study is to characterize, according to Stewart's approach, the acid-base equilibrium of CSF and arterial plasma of pregnant women and compare the results with data obtained from fertile, non-pregnant women.

详细描述

The reduction in plasma PCO2 correlates with gestational age and was shown to be associated to plasma progesterone concentrations. We hypothesize that pregnancy-related haemodilution, inducing a reduction in CSF Strong Ion Difference (SID), might have a role in the development of pregnancy-related hypocapnic alkalosis.

Samples of CSF and arterial plasma of pregnant women with gestational age > 35 weeks undergoing spinal anesthesia for elective caesarean section will be analyzed for blood gases, pH, electrolytes, osmolality, albumin and haemoglobin concentration. In addition plasma copeptin levels will be analyzed. The same measurements will be performed in fertile, non-pregnant women undergoing spinal anesthesia for elective surgery.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Pregnancy with gestational age > 35 weeks
  • Scheduled elective cesarean section under spinal anesthesia

排除标准

  • known respiratory or neurologic disease
  • multiple pregnancies

结局指标

主要结局

Strong Ion Difference

时间窗: 1 day

Strong Ion Difference (expressed in milliequivalents per Liter \[mEq/L\]) of cerebrospinal fluid and arterial plasma

次要结局

  • Partial pressure of carbon dioxide (PCO2)(1 day)
  • Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L)(1 day)
  • Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID)(1 day)
  • Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2)(1 day)
  • Progesterone levels(1 day)
  • Copeptin levels(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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