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Clinical Trials/NCT03496311
NCT03496311
Unknown
Not Applicable

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

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 site in 1 country40 target enrollmentApril 13, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acid-Base Imbalance
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Enrollment
40
Locations
1
Primary Endpoint
Strong Ion Difference
Last Updated
8 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 13, 2018
End Date
April 2019
Last Updated
8 years ago
Study Type
Observational
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • known respiratory or neurologic disease
  • multiple pregnancies

Outcomes

Primary Outcomes

Strong Ion Difference

Time Frame: 1 day

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

Secondary Outcomes

  • 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)

Study Sites (1)

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