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

April 16, 2018 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing spinal anesthesia either for elective cesarean section of for elective surgery.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Milan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSF acid-base in pregnancy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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