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

Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)
Overall Status
Unknown status
CT.gov ID
NCT03496311
Collaborator
University of Milan (Other)
40
1
11.6
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Acid - Base characterization

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Effects of Pregnancy on the Physico-chemical Characteristics of Cerebrospinal Acid-base Equilibrium
Actual Study Start Date :
Apr 13, 2018
Anticipated Primary Completion Date :
Apr 1, 2019
Anticipated Study Completion Date :
Apr 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Pregnant Women

Pregnant women with gestational age > 35 weeks undergoing spinal anesthesia for elective cesarean section.

Diagnostic Test: Acid - Base characterization
Samples of cerebrospinal fluid and arterial blood will be collected anaerobically to measure acid-base variables, electrolytes, albumin, progesterone and copeptin levels

Control Group

Fertile, non-pregnant women undergoing spinal anesthesia for elective surgery.

Diagnostic Test: Acid - Base characterization
Samples of cerebrospinal fluid and arterial blood will be collected anaerobically to measure acid-base variables, electrolytes, albumin, progesterone and copeptin levels

Outcome Measures

Primary Outcome Measures

  1. Strong Ion Difference [1 day]

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

Secondary Outcome Measures

  1. Partial pressure of carbon dioxide (PCO2) [1 day]

    PCO2 (expressed in millimeters of Mercury [mmHg]) of cerebrospinal fluid and arterial plasma

  2. Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L) [1 day]

    The 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

  3. Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID) [1 day]

    The 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

  4. Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2) [1 day]

    The 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

  5. Progesterone levels [1 day]

    Plasma and CSF Progesterone levels (expressed in ng/mL) will be measured

  6. Copeptin levels [1 day]

    Plasma copeptin levels (expressed in pmol/L) will be measured as a marker of antidiuretic hormone activity

Other Outcome Measures

  1. SID PCO2 correlation [1 day]

    Correlation between CSF SID and PCO2

  2. Osmolality PCO2 correlation [1 day]

    Correlation between CSF osmolality and PCO2

  3. Plasma progesterone PCO2 correlation [1 day]

    Correlation between plasma progesterone concentration and plasma PCO2

  4. CSF progesterone PCO2 correlation [1 day]

    Correlation between CSF progesterone concentration and CSF PCO2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan Italy

Sponsors and Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • University of Milan

Investigators

  • Principal Investigator: Thomas Langer, MD, University of Milan
  • Study Director: Antonio Pesenti, MD, University of Milan
  • Study Chair: Edoardo Calderini, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
  • Study Chair: Giorgio Giudici, MD, University of Milan
  • Study Chair: Mariateresa Ambrosini, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT03496311
Other Study ID Numbers:
  • CSF acid-base in pregnancy
First Posted:
Apr 12, 2018
Last Update Posted:
Apr 17, 2018
Last Verified:
Apr 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 17, 2018