Oxidative StressNCT06811714
Comparison of Oxidants and Antioxidants in Breastmilk Under Different Anesthesia Protocols
An observational study of Oxidative Stress, run by Duzce University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine in women undergoing cesarean section if total oxidant status and total antioxidant status in breastmilk taken at the 6th hour postoperatively changes between general and regional anesthetic protocols. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2025to 1 Jul 2025
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women undergoing elective cesarean section under general or regional anesthesia in operating rooms of Duzce University Health Research Center
Who may be able to join
- Patients undergoing cesarean section under general or regional anesthesia
- Patients in the I and II risk groups, according to the American Society of Anesthesiologists (ASA) classification
Who cannot join
- Pregnant women with ASA III and above,
- Pregnant women with gestational DM or hypertension,
- Pregnant women with an indication for Intensive Care Unit (ICU),
- Pregnant women with chronic obstructive pulmonary disease,
- Pregnant women with morbid obesity,
- Pregnant women with a history of liver or kidney disease,
- Pregnant women with coronary artery disease or heart failure,
- Pregnant women with significant anemia (Hg<7).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Total Oxidant and Total Antioxidant Status in Breast Milk After Caesarean Section Under General and Regional Anesthesia
The goal of this observational study is to determine in women undergoing cesarean section if total oxidant status and total antioxidant status in breastmilk taken at the 6th hour postoperatively changes between general and regional anesthetic protocols.
Researchers will compare general anesthesia and regional anesthesia groups to see if total oxidant status and total antioxidant status in breastmilk taken at the 6th hour postoperatively changes.
Participants will provide 2 ml of breastmilk at the 6th postoperative hour.
Read the detailed description
In recent years, the rate of cesarean delivery in our country has ranged between 46% and 54%. Anesthesiologists only have safety concerns for the patient during routine surgery. In cesarean section operations, all the changes that occur in the mother can affect the fetus. This makes cesarean section operations more special than other surgeries. Cesarean section operations can be performed under general anesthesia and regional anesthesia methods. In recent years, regional anesthesia has been preferred because of its advantages, such as patient's request, consciousness, no need for intubation, no risk of aspiration, no respiratory depression in the newborn, and no uterine atony. However, general anesthesia is also frequently used in emergencies, patient requests, and contraindications to regional anesthesia.
Breast milk is the most appropriate nutritional product for newborns. Only breast milk is recommended for newborns for the first 4-6 months. During the period when infants are breastfed, some drugs used by the mother may pass into breast milk and cause adverse effects in infants. Most of the cases of adverse effects due to drugs passing into breast milk occur in newborns younger than two months, especially in the first month of life. In line with this information, it is known that anesthetic drugs also pass into breast milk. Whether it is general anesthesia or regional anesthesia, anesthetic drugs are excreted into breast milk in minimal doses. However, studies show that the anesthetic drugs that pass into breast milk are at levels that do not cause serious side effects in the baby.
Many risk factors can cause oxidative stress, including alcohol, drugs, environmental pollutants, intense exercise, inflammation, and sepsis. Biological targets most exposed to oxidative damage include enzymes, cell membranes, and DNA. Oxygen radicals have been implicated as an essential cause of mechanisms that can lead to the rapid degradation of proteins. Free radical-induced changes in proteins increase the degradation of enzymes. Oxidative damage to protein products can affect the activity of enzymes, receptors, and transporter proteins. Oxidatively damaged protein products may contain reactive groups that can damage the cell membrane and many cellular functions. Peroxidation of lipids occurs when biological membranes react with unsaturated fatty acids and proceed by radical chain reaction. Oxidative events cause changes in the physical-chemical properties of membranes and thus alter fluidity and permeability, with membranes disintegrating with swelling of intracellular organelles. DNA and RNA are sensitive to oxidative damage. DNA is thought to be the main target, especially in aging and cancer. Oxidative nucleotides such as glycol, thymidine glycol, and 8-hydroxy-2- deoxyguanosine have increased during oxidative damage to DNA by UV radiation or free radical damage. Mitochondrial DNA has been reported to be more susceptible to oxidative damage in many diseases, including cancer.
In the literature review in which we investigated the effects of anesthesia on breast milk, the amount of drugs such as anesthetic agents, narcotic agents, and muscle relaxants in breast milk in the postoperative period was investigated. However, no study has been found to show how oxidative stress parameters change in breast milk due to both the anesthetic technique used and secondary causes (stress, tissue damage, etc.) caused by the operation in a newly operated mother. Our study aimed to compare oxidative stress parameters in breast milk after cesarean section under general anesthesia and regional anesthesia. A comprehensive research evaluating total oxidant/antioxidant systems was not found in our literature review. Therefore, our study will contribute to the literature.
- Conditions
- Oxidative Stress
- Keywords
- oxidative stress, cesarean section, anesthesia, general, anesthesia, regional, breastmilk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | 64 Patients undergoing cesarean section under general anesthesia | |
| Regional Anesthesia | 64 Patients undergoing cesarean section under regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total oxidant status
Total oxidant status in breastmilk taken at 6th postoperative hour will be measured.
Measured: Postoperative 24 hours
Total antioxidant status
Total antioxidant status in breastmilk taken at the 6th postoperative hour will be measured.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start6 Feb 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duzce University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ersoy Karka, Duzce University
- Investigators
- Özlem Ersoy Karka, Ass. Prof., Principal investigator, Düzce University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811714
- Sponsor's protocol ID
- drozlemersoy6
- Status last verified
- Jun 2025
- First submitted
- 31 Jan 2025
- Last updated
- 25 Nov 2025
- 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 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Oxidant and Total Antioxidant Status in Breast Milk After Caesarean Section Under General and Regional Anesthesia
- ClinicalTrials.gov ID
- NCT06811714
- Acronym / sponsor ID
- drozlemersoy6
- Conditions
- Oxidative Stress
- Keywords
- oxidative stress, cesarean section, anesthesia, general, anesthesia, regional, breastmilk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Duzce UniversityUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 6 Feb 2025 (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 determine in women undergoing cesarean section if total oxidant status and total antioxidant status in breastmilk taken at the 6th hour postoperatively changes between general and regional anesthetic protocols.
Researchers will compare general anesthesia and regional anesthesia groups to see if total oxidant status and total antioxidant status in breastmilk taken at the 6th hour postoperatively changes.
Participants will provide 2 ml of breastmilk at the 6th postoperative hour.
Detailed description
In recent years, the rate of cesarean delivery in our country has ranged between 46% and 54%. Anesthesiologists only have safety concerns for the patient during routine surgery. In cesarean section operations, all the changes that occur in the mother can affect the fetus. This makes cesarean section operations more special than other surgeries. Cesarean section operations can be performed under general anesthesia and regional anesthesia methods. In recent years, regional anesthesia has been preferred because of its advantages, such as patient's request, consciousness, no need for intubation, no risk of aspiration, no respiratory depression in the newborn, and no uterine atony. However, general anesthesia is also frequently used in emergencies, patient requests, and contraindications to regional anesthesia.
Breast milk is the most appropriate nutritional product for newborns. Only breast milk is recommended for newborns for the first 4-6 months. During the period when infants are breastfed, some drugs used by the mother may pass into breast milk and cause adverse effects in infants. Most of the cases of adverse effects due to drugs passing into breast milk occur in newborns younger than two months, especially in the first month of life. In line with this information, it is known that anesthetic drugs also pass into breast milk. Whether it is general anesthesia or regional anesthesia, anesthetic drugs are excreted into breast milk in minimal doses. However, studies show that the anesthetic drugs that pass into breast milk are at levels that do not cause serious side effects in the baby.
Many risk factors can cause oxidative stress, including alcohol, drugs, environmental pollutants, intense exercise, inflammation, and sepsis. Biological targets most exposed to oxidative damage include enzymes, cell membranes, and DNA. Oxygen radicals have been implicated as an essential cause of mechanisms that can lead to the rapid degradation of proteins. Free radical-induced changes in proteins increase the degradation of enzymes. Oxidative damage to protein products can affect the activity of enzymes, receptors, and transporter proteins. Oxidatively damaged protein products may contain reactive groups that can damage the cell membrane and many cellular functions. Peroxidation of lipids occurs when biological membranes react with unsaturated fatty acids and proceed by radical chain reaction. Oxidative events cause changes in the physical-chemical properties of membranes and thus alter fluidity and permeability, with membranes disintegrating with swelling of intracellular organelles. DNA and RNA are sensitive to oxidative damage. DNA is thought to be the main target, especially in aging and cancer. Oxidative nucleotides such as glycol, thymidine glycol, and 8-hydroxy-2- deoxyguanosine have increased during oxidative damage to DNA by UV radiation or free radical damage. Mitochondrial DNA has been reported to be more susceptible to oxidative damage in many diseases, including cancer.
In the literature review in which we investigated the effects of anesthesia on breast milk, the amount of drugs such as anesthetic agents, narcotic agents, and muscle relaxants in breast milk in the postoperative period was investigated. However, no study has been found to show how oxidative stress parameters change in breast milk due to both the anesthetic technique used and secondary causes (stress, tissue damage, etc.) caused by the operation in a newly operated mother. Our study aimed to compare oxidative stress parameters in breast milk after cesarean section under general anesthesia and regional anesthesia. A comprehensive research evaluating total oxidant/antioxidant systems was not found in our literature review. Therefore, our study will contribute to the literature.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | –64 Patients undergoing cesarean section under general anesthesia |
| Regional Anesthesia | – | –64 Patients undergoing cesarean section under regional anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing elective cesarean section under general or regional anesthesia in operating rooms of Duzce University Health Research Center
Key inclusion criteria (2 listed)
- Patients undergoing cesarean section under general or regional anesthesia
- Patients in the I and II risk groups, according to the American Society of Anesthesiologists (ASA) classification
Key exclusion criteria (8 listed)
- Pregnant women with ASA III and above,
- Pregnant women with gestational DM or hypertension,
- Pregnant women with an indication for Intensive Care Unit (ICU),
- Pregnant women with chronic obstructive pulmonary disease,
- Pregnant women with morbid obesity,
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
Total oxidant status
Time frame: Postoperative 24 hours
Total oxidant status in breastmilk taken at 6th postoperative hour will be measured.
Total antioxidant status
Time frame: Postoperative 24 hours
Total antioxidant status in breastmilk taken at the 6th postoperative hour will be measured.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
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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.
Özlem Ersoy Karka, Ass. Prof. principal investigator
Düzce University Faculty of Medicine
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 Oxidative Stress, run by Duzce University 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 8 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: finished, as of the sponsor's last update on 25 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total oxidant status (time frame: Postoperative 24 hours). The study lists 2 primary outcomes in all. 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 25 Nov 2025.