Obstetric Anesthesia ProblemsNCT05973435
Evaluation of the Level of Oxidative Stress in Relation to the Type of Anesthesia in Parturients Whose Delivery Was Completed by Caesarean Section
An observational study of Obstetric Anesthesia Problems, run by University Clinic Dr Dragisa Misovic-Dedinje at 1 site in Serbia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstetric Anesthesia Problems
- What is being tested?
- Blood sampling
- How many people
- 100 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Mar 2023to 1 Oct 2023
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women
Who may be able to join
- ASA status I and II
Who cannot join
- ASA status III and IV
- Emergency C section
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Clinical Hospital Center "Dr. Dragisa Misovic, Dedinje"
Belgrade, 11000
About this study
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:
Read more
- 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
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Not described Receives: Other: Blood sampling | |
| Spinal anesthesia | Not described Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elevated level of oxidative stress
We will measure enzymes of oxidative stress before cesarean section, during cesarean section and after cesarean section.
Measured: 2 hours after C section
Secondary outcomes (2)
Lactate level
We will measure lactate levels before cesarean section, during cesarean section and after cesarean section.
Measured: 2 hours after C section
Level of cortisol
We will measure cortisol levels before cesarean section, during cesarean section and after cesarean section.
Measured: 2 hours after C section
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start1 Mar 2023
- Primary completion1 Aug 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Anesthesia ProblemsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Clinic Dr Dragisa Misovic-Dedinje
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Boboš, University Clinic Dr Dragisa Misovic-Dedinje
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973435
- Sponsor's protocol ID
- 17/I-4
- Status last verified
- Nov 2023
- First submitted
- 25 Jul 2023
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05973435
- Acronym / sponsor ID
- 17/I-4
- Conditions
- Obstetric Anesthesia Problems
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Clinic Dr Dragisa Misovic-DedinjeUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 2 Aug 2023 (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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | – | Other: Blood sampling |
| Spinal anesthesia | – | Other: Blood sampling |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women
Key inclusion criteria (1 listed)
- ASA status I and II
Key exclusion criteria (2 listed)
- ASA status III and IV
- Emergency C section
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood 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). | Other | General Anesthesia, Spinal anesthesia |
Primary outcome
Elevated level of oxidative stress
Time frame: 2 hours after C section
We will measure enzymes of oxidative stress before cesarean section, during cesarean section and after cesarean section.
2 secondary outcomes
Lactate level
Time frame: 2 hours after C section
Level of cortisol
Time frame: 2 hours after C section
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 4 Dec 2023.
- Individual participant dataSharing planned: No
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Obstetric, Cesarean Birth
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Obstetric Anesthesia Problems, run by University Clinic Dr Dragisa Misovic-Dedinje at 1 site in Serbia.
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 1 inclusion and 2 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 4 Dec 2023. 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 Serbia. 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?
Elevated level of oxidative stress (time frame: 2 hours after C section). 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 4 Dec 2023.