Cerebrospinal Acid-base in Pregnant and Non-pregnant Fertile Women
NCT ID: NCT03496311
Last Updated: 2018-04-17
Study Results
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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UNKNOWN
40 participants
OBSERVATIONAL
2018-04-13
2019-04-30
Brief Summary
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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.
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Detailed Description
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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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Study Design
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CASE_CONTROL
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
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
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
Eligibility Criteria
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Inclusion Criteria
* Scheduled elective cesarean section under spinal anesthesia
Exclusion Criteria
* multiple pregnancies
18 Years
FEMALE
No
Sponsors
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University of Milan
OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
Other Identifiers
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CSF acid-base in pregnancy
Identifier Type: -
Identifier Source: org_study_id
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