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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05973435
Other study ID # 17/I-4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date October 1, 2023

Study information

Verified date November 2023
Source University Clinic Dr Dragisa Misovic-Dedinje
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - ASA status I and II Exclusion Criteria: - ASA status III and IV - Emergency C section

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Serbia Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje" Belgrade

Sponsors (1)

Lead Sponsor Collaborator
University Clinic Dr Dragisa Misovic-Dedinje

Country where clinical trial is conducted

Serbia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Elevated level of oxidative stress We will measure enzymes of oxidative stress before cesarean section, during cesarean section and after cesarean section. 2 hours after C section
Secondary Lactate level We will measure lactate levels before cesarean section, during cesarean section and after cesarean section. 2 hours after C section
Secondary Level of cortisol We will measure cortisol levels before cesarean section, during cesarean section and after cesarean section. 2 hours after C section
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