Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section

November 28, 2023 updated by: Marina Boboš, University Clinic Dr Dragisa Misovic-Dedinje

The goal of this observational study is to assess the level of oxidative stress during cesarean section depending on the type of anesthesia applied and to determine the factors that can affect the level of oxidative stress.

The main questions it aims to answer are:

  • is there any association between specific parameters of pregnancy, socio-demographic characteristics and laboratory analyses with an increased level of oxidative stress
  • is there any association between type of anesthesia for ceasarean section with an increased level of oxidative stress

Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).

Researchers will compare patients that received general anesthesia with patients under spinal regional anesthesia to see if there is any difference in level of oxidative stress measured by laboratory parameters.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

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 Backup

Study Locations

  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"

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

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Healthy pregnant women

Description

Inclusion Criteria:

  • ASA status I and II

Exclusion Criteria:

  • ASA status III and IV
  • Emergency C section

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
Intervention / Treatment
General Anesthesia
Other: Blood sampling
Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).
Spinal anesthesia
Other: Blood sampling
Blood sample would be taken from the participants in the study for these analyses on three occasions in 3 test tubes (before cesarean section, during cesarean section and after cesarean section).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elevated level of oxidative stress
Time Frame: 2 hours after C section
We will measure enzymes of oxidative stress before cesarean section, during cesarean section and after cesarean section.
2 hours after C section

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lactate level
Time Frame: 2 hours after C section
We will measure lactate levels before cesarean section, during cesarean section and after cesarean section.
2 hours after C section
Level of cortisol
Time Frame: 2 hours after C section
We will measure cortisol levels before cesarean section, during cesarean section and after cesarean section.
2 hours after C section

Collaborators and Investigators

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

Sponsor

University Clinic Dr Dragisa Misovic-Dedinje

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)

March 1, 2023

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

October 1, 2023

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

December 4, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 17/I-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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