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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03496311
Other study ID # CSF acid-base in pregnancy
Secondary ID
Status Recruiting
Phase
First received March 29, 2018
Last updated April 16, 2018
Start date April 13, 2018
Est. completion date April 2019

Study information

Verified date April 2018
Source Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Contact Thomas Langer, MD
Phone +390250320463
Email thomas.langer@unimi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date April 2019
Est. primary completion date April 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Pregnancy with gestational age > 35 weeks

- Scheduled elective cesarean section under spinal anesthesia

Exclusion Criteria:

- known respiratory or neurologic disease

- multiple pregnancies

Study Design


Intervention

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

Locations

Country Name City State
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milan

Sponsors (2)

Lead Sponsor Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico University of Milan

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Other SID PCO2 correlation Correlation between CSF SID and PCO2 1 day
Other Osmolality PCO2 correlation Correlation between CSF osmolality and PCO2 1 day
Other Plasma progesterone PCO2 correlation Correlation between plasma progesterone concentration and plasma PCO2 1 day
Other CSF progesterone PCO2 correlation Correlation between CSF progesterone concentration and CSF PCO2 1 day
Primary Strong Ion Difference Strong Ion Difference (expressed in milliequivalents per Liter [mEq/L]) of cerebrospinal fluid and arterial plasma 1 day
Secondary Partial pressure of carbon dioxide (PCO2) PCO2 (expressed in millimeters of Mercury [mmHg]) of cerebrospinal fluid and arterial plasma 1 day
Secondary Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L) 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 1 day
Secondary Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID) 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 1 day
Secondary Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2) 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 1 day
Secondary Progesterone levels Plasma and CSF Progesterone levels (expressed in ng/mL) will be measured 1 day
Secondary Copeptin levels Plasma copeptin levels (expressed in pmol/L) will be measured as a marker of antidiuretic hormone activity 1 day
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