Cesarean SectionNCT06206928
Evaluation of Mitochondrial Enzyme Activity in Cesarean Section Patients
An observational study of Cesarean Section and Spinal Anesthesia, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Section, Spinal Anesthesia, Thiol Groups
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 1 Feb 2024
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Patients who will undergo planned cesarean section between the ages of 18 and 40
Who may be able to join
- Patients who will undergo planned cesarean section between the ages of 18 and 40
- ASA 1-2 Patients
Who cannot join
- 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
Show all 9Show fewer
- Patients diagnosed with preeclampsia
- Patients with body mass index ≥ 30
- Patients who do not accept spinal anesthesia or have contraindications to the application -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Şanlıurfa Training and Research Hospital
Sanliurfa, 63250
mehmet tercan, assoc prof
Alev Esercan, MD
About this study
Official title: Investigation of Trace Element Metabolism and Tricarboxylic Acid Cycle Enzyme Activities in Patients Who Underwent Cesarean Section With Spinal Anesthesia
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.
Read the detailed description
Although the World Health Organization recommends the cesarean birth rate as 10-15%, the cesarean birth rate in Turkey is 57.3% according to 2020 data, ranking first in the world. This rate is around 30% for primary cesarean delivery. Although there are various methods of anesthesia for cesarean birth, spinal block is a regional anesthesia method frequently used in elective cesarean births because it is easy to apply, has a rapid onset of effect and provides a good sensory block. With this anesthesia method, local anesthetic solution is administered to the subarachnoid space to create sensory and motor block within the surgical area.
Although trace elements (Zinc (Zn), Iron (Fe), Copper (Cu)) constitute a small part of the human body, they play a very important role in maintaining normal metabolic function. Deficiency or excess of these elements causes dysfunction of the relevant enzymes (such as alcohol dehydrogenase, alkaline phosphatase, lactate dehydrogenase, carboxypeptidase, carbonic anhydrase, superoxide dismutase (SOD), DNA and RNA polymerase) and thus various clinical findings (postpartum hemorrhage, fetal growth restriction). FGR), fetal malformations, premature birth, preeclampsia).
In recent years, it has been revealed that thiol-disulfide homeostasis may be an important biomarker of oxidative stress. Thiol is a compound containing sulfhydryl group (-SH) that plays an important role in preventing oxidative stress in cells. Thiols are not only a redox buffer in the body but also an essential element of the antioxidant defense system. Abnormal thiol-disulfide balance levels are associated with oxidative stress. There is a balance between oxidative stress and antioxidant defense mechanisms. The changes in this balance depending on many factors are frequently investigated in patients undergoing surgery.
This study aimed to contribute to the literature by investigating the effects of trace element metabolism, tricarboxylic acid cycle enzyme activities and thiol/disulfide balance in patients who underwent cesarean section under spinal anesthesia.
- Conditions
- Cesarean Section, Spinal Anesthesia, Thiol Groups
- Keywords
- cesarean section, spinal anesthesia, mitochondrial enzyme changes, thiol disulfide balance
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion20 Jan 2024 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Tercan, Sanliurfa Mehmet Akif Inan Education and Research Hospital
- Investigators
- MEHMET TERCAN, Assoc Prof, Principal investigator, University of Health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206928
- Sponsor's protocol ID
- HRÜ/22.15.11
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Trace Element Metabolism and Tricarboxylic Acid Cycle Enzyme Activities in Patients Who Underwent Cesarean Section With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06206928
- Acronym / sponsor ID
- HRÜ/22.15.11
- Conditions
- Cesarean Section, Spinal Anesthesia, Thiol Groups
- Keywords
- cesarean section, spinal anesthesia, mitochondrial enzyme changes, thiol disulfide balance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sanliurfa Mehmet Akif Inan Education and Research HospitalUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 20 Jan 2024 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although the World Health Organization recommends the cesarean birth rate as 10-15%, the cesarean birth rate in Turkey is 57.3% according to 2020 data, ranking first in the world. This rate is around 30% for primary cesarean delivery. Although there are various methods of anesthesia for cesarean birth, spinal block is a regional anesthesia method frequently used in elective cesarean births because it is easy to apply, has a rapid onset of effect and provides a good sensory block. With this anesthesia method, local anesthetic solution is administered to the subarachnoid space to create sensory and motor block within the surgical area.
Although trace elements (Zinc (Zn), Iron (Fe), Copper (Cu)) constitute a small part of the human body, they play a very important role in maintaining normal metabolic function. Deficiency or excess of these elements causes dysfunction of the relevant enzymes (such as alcohol dehydrogenase, alkaline phosphatase, lactate dehydrogenase, carboxypeptidase, carbonic anhydrase, superoxide dismutase (SOD), DNA and RNA polymerase) and thus various clinical findings (postpartum hemorrhage, fetal growth restriction). FGR), fetal malformations, premature birth, preeclampsia).
In recent years, it has been revealed that thiol-disulfide homeostasis may be an important biomarker of oxidative stress. Thiol is a compound containing sulfhydryl group (-SH) that plays an important role in preventing oxidative stress in cells. Thiols are not only a redox buffer in the body but also an essential element of the antioxidant defense system. Abnormal thiol-disulfide balance levels are associated with oxidative stress. There is a balance between oxidative stress and antioxidant defense mechanisms. The changes in this balance depending on many factors are frequently investigated in patients undergoing surgery.
This study aimed to contribute to the literature by investigating the effects of trace element metabolism, tricarboxylic acid cycle enzyme activities and thiol/disulfide balance in patients who underwent cesarean section under spinal anesthesia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who will undergo planned cesarean section between the ages of 18 and 40
Key inclusion criteria (2 listed)
- Patients who will undergo planned cesarean section between the ages of 18 and 40
- ASA 1-2 Patients
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Biochemical parameter measurements that we mentioned in the description
Time frame: 1 day
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MEHMET TERCAN, Assoc Prof principal investigator
University of Health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section and Spinal Anesthesia, run by Sanliurfa Mehmet Akif Inan Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mehmet Tercan, Assoc Prof (+905323445635, drmtercan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical parameter measurements that we mentioned in the description (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024; AzTrials last refreshed its copy on 6 Nov 2026.