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Cerebrospinal Acid-base in Pregnant and Non-pregnant Fertile Women

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03496311
Enrollment
40
Registered
2018-04-12
Start date
2018-04-13
Completion date
2019-04-30
Last updated
2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acid-Base Imbalance, Cerebrospinal Fluid, Pregnancy, Respiratory Alkalosis

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.

Interventions

DIAGNOSTIC_TESTAcid - Base characterization

Samples of cerebrospinal fluid and arterial blood will be collected anaerobically to measure acid-base variables, electrolytes, albumin, progesterone and copeptin levels

Sponsors

University of Milan
CollaboratorOTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* known respiratory or neurologic disease * multiple pregnancies

Design outcomes

Primary

MeasureTime frameDescription
Strong Ion Difference1 dayStrong Ion Difference (expressed in milliequivalents per Liter \[mEq/L\]) of cerebrospinal fluid and arterial plasma

Secondary

MeasureTime frameDescription
Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L)1 dayThe total amount of weak non carbonic acids, i.e. the sum of albumin and phosphates (both expressed in mmol/L) of cerebrospinal fluid and arterial plasma
Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID)1 dayThe difference between plasma and cerebrospinal fluid SID (expressed in mEq/L) will be calculated as marker of electrolyte inbalance between these two extracellular fluid compartments. Delta SID = SIDcsf - SIDplasma
Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2)1 dayThe difference between cerebrospinal fluid and arterial plasma PCO2 (expressed in mmHg) will be calculated as a marker of acid-base equilibrium between these two extracellular fluid compartments. Delta PCO2 = SIDplasma - SIDcsf
Progesterone levels1 dayPlasma and CSF Progesterone levels (expressed in ng/mL) will be measured
Copeptin levels1 dayPlasma copeptin levels (expressed in pmol/L) will be measured as a marker of antidiuretic hormone activity
Partial pressure of carbon dioxide (PCO2)1 dayPCO2 (expressed in millimeters of Mercury \[mmHg\]) of cerebrospinal fluid and arterial plasma

Other

MeasureTime frameDescription
Plasma progesterone PCO2 correlation1 dayCorrelation between plasma progesterone concentration and plasma PCO2
CSF progesterone PCO2 correlation1 dayCorrelation between CSF progesterone concentration and CSF PCO2
Osmolality PCO2 correlation1 dayCorrelation between CSF osmolality and PCO2
SID PCO2 correlation1 dayCorrelation between CSF SID and PCO2

Countries

Italy

Contacts

Primary ContactThomas Langer, MD
thomas.langer@unimi.it+390250320463

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026