- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03496311
Cerebrospinal Acid-base in Pregnant and Non-pregnant Fertile Women
Effects of Pregnancy on the Physico-chemical Characteristics of Cerebrospinal Acid-base Equilibrium
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Thomas Langer, MD
- Phone Number: +390250320463
- Email: thomas.langer@unimi.it
Study Locations
-
-
-
Milan, Italy
- Recruiting
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
-
Contact:
- Thomas Langer, MD
- Email: thomas.langer@unimi.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant Women
Pregnant women with gestational age > 35 weeks undergoing spinal anesthesia for elective cesarean section.
|
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.
|
Samples of cerebrospinal fluid and arterial blood will be collected anaerobically to measure acid-base variables, electrolytes, albumin, progesterone and copeptin levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Strong Ion Difference
Time Frame: 1 day
|
Strong Ion Difference (expressed in milliequivalents per Liter [mEq/L]) of cerebrospinal fluid and arterial plasma
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Partial pressure of carbon dioxide (PCO2)
Time Frame: 1 day
|
PCO2 (expressed in millimeters of Mercury [mmHg]) of cerebrospinal fluid and arterial plasma
|
1 day
|
Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L)
Time Frame: 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
|
1 day
|
Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID)
Time Frame: 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
|
1 day
|
Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2)
Time Frame: 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
|
1 day
|
Progesterone levels
Time Frame: 1 day
|
Plasma and CSF Progesterone levels (expressed in ng/mL) will be measured
|
1 day
|
Copeptin levels
Time Frame: 1 day
|
Plasma copeptin levels (expressed in pmol/L) will be measured as a marker of antidiuretic hormone activity
|
1 day
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SID PCO2 correlation
Time Frame: 1 day
|
Correlation between CSF SID and PCO2
|
1 day
|
Osmolality PCO2 correlation
Time Frame: 1 day
|
Correlation between CSF osmolality and PCO2
|
1 day
|
Plasma progesterone PCO2 correlation
Time Frame: 1 day
|
Correlation between plasma progesterone concentration and plasma PCO2
|
1 day
|
CSF progesterone PCO2 correlation
Time Frame: 1 day
|
Correlation between CSF progesterone concentration and CSF PCO2
|
1 day
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Thomas Langer, MD, University of Milan
- Study Director: Antonio Pesenti, MD, University of Milan
- Study Chair: Giorgio Giudici, MD, University of Milan
- Study Chair: Mariateresa Ambrosini, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSF acid-base in pregnancy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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