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

NCT ID: NCT03496311

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-13

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Acid-Base Imbalance Respiratory Alkalosis Cerebrospinal Fluid Pregnancy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant Women

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

Acid - Base characterization

Intervention Type DIAGNOSTIC_TEST

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.

Acid - Base characterization

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* known respiratory or neurologic disease
* multiple pregnancies
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Milan

OTHER

Sponsor Role collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Langer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Milan

Antonio Pesenti, MD

Role: STUDY_DIRECTOR

University of Milan

Edoardo Calderini, MD

Role: STUDY_CHAIR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Giorgio Giudici, MD

Role: STUDY_CHAIR

University of Milan

Mariateresa Ambrosini, MD

Role: STUDY_CHAIR

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Locations

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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Thomas Langer, MD

Role: CONTACT

+390250320463

Facility Contacts

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Thomas Langer, MD

Role: primary

References

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Zadek F, Giudici G, Ferraris Fusarini C, Ambrosini MT, di Modugno A, Scaravilli V, Zanella A, Fumagalli R, Stocchetti N, Calderini E, Langer T. Cerebrospinal fluid and arterial acid-base equilibria in spontaneously breathing third-trimester pregnant women. Br J Anaesth. 2022 Nov;129(5):726-733. doi: 10.1016/j.bja.2022.07.048. Epub 2022 Sep 10.

Reference Type DERIVED
PMID: 36096944 (View on PubMed)

Other Identifiers

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CSF acid-base in pregnancy

Identifier Type: -

Identifier Source: org_study_id

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