NCT06206928

Brief Summary

The goal of this observational study is to learn about in effects of trace element metabolism, tricarboxylic acid cycle enzyme activities and thiol/disulfide balance in patients who underwent cesarean section under spinal anesthesia. The main question\[s\] it aims to answer are: • What is the effect of trace element metabolism, tricarboxylic acid cycle enzyme activities and thiol/disulfide balance in patients undergoing cesarean section under regional anesthesia? A 10 ml blood sample will be taken from the participants to analyze the biochemical parameters mentioned before and after the operation. Pre- and post-operative values will be compared.

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2024

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2024

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

Same day

First QC Date

December 27, 2023

Last Update Submit

January 12, 2024

Conditions

Keywords

cesarean sectionspinal anesthesiamitochondrial enzyme changesthiol disulfide balance

Outcome Measures

Primary Outcomes (1)

  • Biochemical parameter measurements that we mentioned in the description

    Serum zinc concentrations were measured with commercially available Rel Assay zinc measurement kit (Gaziantep, Turkey) using a fully automatic photometric method (Abbott ARCHITECT c8000 clinical chemistry analyzer). Serum copper concentrations were measured with commercially available Rel Assay copper measurement kit (Gaziantep, Turkey), using a fully automatic photometric method (Abbott ARCHITECT c8000 clinical chemistry analyzer). Serum levels of total and native thiol were measured with a novel method developed by Erel and Neselioglu. In this method, serum dynamic disulfide bonds (-S-S-) is reduced to native thiol groups (-SH HS-) by sodium borohydride (NaBH4) and native thiol levels were measured.

    1 day

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSince this study was planned in patients who underwent cesarean section under spinal anesthesia
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients who will undergo planned cesarean section between the ages of 18 and 40

You may qualify if:

  • Patients who will undergo planned cesarean section between the ages of 18 and 40
  • ASA 1-2 Patients

You may not qualify if:

  • Patients who refuse to participate in the study
  • Patients over 40 years of age
  • ASA 3-4 Patients
  • Patients who underwent emergency cesarean section
  • Those with known liver and kidney diseases, patients diagnosed with Diabetes Mellitus
  • Pregnant women diagnosed with an abnormal baby
  • Patients diagnosed with preeclampsia
  • Patients with body mass index ≥ 30
  • Patients who do not accept spinal anesthesia or have contraindications to the application -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şanlıurfa Training and Research Hospital

Sanliurfa, 63250, Turkey (Türkiye)

Location

Study Officials

  • MEHMET TERCAN, Assoc Prof

    University of Health science

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet Tercan, Assoc Prof

CONTACT

Ahmet Kaya, Assoc Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 27, 2023

First Posted

January 16, 2024

Study Start

January 20, 2024

Primary Completion

January 20, 2024

Study Completion

February 1, 2024

Last Updated

January 16, 2024

Record last verified: 2024-01

Locations