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

NCT05973435 | Completed

• 1 other identifier: 17/I-4
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstetric Anesthesia Problems

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Lactate level

  2 hours after C section

• Level of cortisol

  2 hours after C section

Study Arms (2)

General Anesthesia

Other: Blood sampling

Spinal anesthesia

Other: Blood sampling

Interventions

Blood sampling OTHER

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).

General Anesthesia; Spinal anesthesia

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy pregnant women

You may qualify if:

• ASA status I and II

You may not qualify if:

• ASA status III and IV
• Emergency C section

Sponsors & Collaborators

• University Clinic Dr Dragisa Misovic-Dedinje: lead

Study Sites (1)

Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"

Belgrade, 11000, Serbia

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 25, 2023
• First Posted: August 2, 2023
• Study Start: March 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)