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

Obstetric Anesthesia Problems Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05973435
• Other study ID #: 17/I-4
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Obstetric Anesthesia Problems

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