NCT03496311

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

April 13, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

March 29, 2018

Last Update Submit

April 16, 2018

Conditions

Acid-Base ImbalanceRespiratory AlkalosisCerebrospinal FluidPregnancy

Outcome Measures

Primary Outcomes (1)

  • Strong Ion Difference

    Strong Ion Difference (expressed in milliequivalents per Liter \[mEq/L\]) of cerebrospinal fluid and arterial plasma

    1 day

Secondary Outcomes (6)

  • Partial pressure of carbon dioxide (PCO2)

    1 day

  • Sum of albumin (expressed in mmol/L) and Phosphates (expressed in mmol/L)

    1 day

  • Difference between cerebrospinal fluid and arterial plasma Strong Ion Difference (Delta SID)

    1 day

  • Difference between cerebrospinal fluid and arterial plasma partial pressure of CO2 (Delta PCO2)

    1 day

  • Progesterone levels

    1 day

  • +1 more secondary outcomes

Other Outcomes (4)

  • SID PCO2 correlation

    1 day

  • Osmolality PCO2 correlation

    1 day

  • Plasma progesterone PCO2 correlation

    1 day

  • +1 more other outcomes

Study Arms (2)

Pregnant Women

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

Diagnostic Test: Acid - Base characterization

Control Group

Fertile, non-pregnant women undergoing spinal anesthesia for elective surgery.

Diagnostic Test: Acid - Base characterization

Interventions

Acid - Base characterizationDIAGNOSTIC_TEST

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

Control GroupPregnant Women

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • known respiratory or neurologic disease
  • multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36096944DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

samples of plasma and cerebrospinal fluid

MeSH Terms

Conditions

Acid-Base ImbalanceAlkalosis, Respiratory

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesHyperventilationRespiration DisordersRespiratory Tract DiseasesAlkalosis

Study Officials

  • Thomas Langer, MD

    University of Milan

    PRINCIPAL INVESTIGATOR

  • Antonio Pesenti, MD

    University of Milan

    STUDY DIRECTOR

  • Edoardo Calderini, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

    STUDY CHAIR

  • Giorgio Giudici, MD

    University of Milan

    STUDY CHAIR

  • Mariateresa Ambrosini, MD

    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

    STUDY CHAIR

Central Study Contacts

Thomas Langer, MD

CONTACT

+390250320463thomas.langer@unimi.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2018

First Posted

April 12, 2018

Study Start

April 13, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations

IT(1)