Anesthesia for Cesarean DeliveryNCT05727449
General or Spinal Anesthesia for Cesarean Delivery
An observational study of Anesthesia for Cesarean Delivery, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
During the cesarean deliveries, one of the anesthesia techniques, regional anesthesia or general anesthesia (GA) is prefered. Spinal anesthesia (SA) is preferred among the regional anesthesia methods because the onset of anesthesia is faster and muscle relaxation is more suitable for cesarean section anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Anesthesia for Cesarean Delivery
- What is being tested?
- General Anesthesia and Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- How many people
- 862 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The pregnant women and their babies in 01.01.2019 - 31.12.2019.
Who may be able to join
- The pregnant women who delivered with cesarean section
Who cannot join
- The pregnant women who delivered with spontan vaginal delivery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of The Effects of General and Spinal Anesthesia for Cesarean Delivery on Maternal and Fetal Outcomes: A Retrospective Analysis of Data in a Third Level Hospital
During the cesarean deliveries, one of the anesthesia techniques, regional anesthesia or general anesthesia (GA) is prefered. Spinal anesthesia (SA) is preferred among the regional anesthesia methods because the onset of anesthesia is faster and muscle relaxation is more suitable for cesarean section anesthesia. Although both methods have advantages and disadvantages, the anesthesia method to be chosen may vary depending on the condition of the mother and fetus.
The goal of this retrospective clinical trial is to compare general and spinal anesthesia in cesarean deliveries. The main questions it aims to answer are:
- Are the anesthesia techniques effect maternal outcome?
- Are the anesthesia techniques effect fetal outcome?
- Conditions
- Anesthesia for Cesarean Delivery
- Being tested
- General Anesthesia, Spinal Anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnesthesiaProcedure or surgery
General Anesthesia was intruduced for Cesarean Delivery
Spinal AnesthesiaProcedure or surgery
Spinal Anesthesia was intraduced for Cesarean Delivery
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia for Cesarean Delivery | Not described Receives: Procedure: General Anesthesia | |
| Spinal Anesthesia for Cesarean Delivery | Not described Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apgar 1st minute score
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health
Measured: 1st minute after birth
Apgar 5th minute score
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health
Measured: 5th minute after birth
Umbilical Cord Blood pH
pH values from umblical cord blood sampling
Measured: at the time of birth
Umbilical Cord Blood PCO2
mmHg
Measured: at the time of birth
Umbilical Cord Blood HCO3
mEq/L
Measured: at the time of birth
Umbilical Cord Blood Lactate
mmol/L
Measured: at the time of birth
Umbilical Cord Blood Base Excess
mEq/L
Measured: at the time of birth
need for neonatal intensive care
need for neonatal intensive care
Measured: up to 24 hours
need for maternal intensive care
need for maternal intensive care
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2019
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia for Cesarean DeliveryStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 862 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mesure gul nihan ozden, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727449
- Sponsor's protocol ID
- IstanbulMU Cesarean Delivery
- Status last verified
- Feb 2023
- First submitted
- 22 Jan 2023
- Last updated
- 22 Feb 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of The Effects of General and Spinal Anesthesia for Cesarean Delivery on Maternal and Fetal Outcomes: A Retrospective Analysis of Data in a Third Level Hospital
- ClinicalTrials.gov ID
- NCT05727449
- Acronym / sponsor ID
- IstanbulMU Cesarean Delivery
- Conditions
- Anesthesia for Cesarean Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 862 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 14 Feb 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.
During the cesarean deliveries, one of the anesthesia techniques, regional anesthesia or general anesthesia (GA) is prefered. Spinal anesthesia (SA) is preferred among the regional anesthesia methods because the onset of anesthesia is faster and muscle relaxation is more suitable for cesarean section anesthesia. Although both methods have advantages and disadvantages, the anesthesia method to be chosen may vary depending on the condition of the mother and fetus.
The goal of this retrospective clinical trial is to compare general and spinal anesthesia in cesarean deliveries. The main questions it aims to answer are:
- Are the anesthesia techniques effect maternal outcome?
- Are the anesthesia techniques effect fetal outcome?
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia for Cesarean Delivery | – | Procedure: General Anesthesia |
| Spinal Anesthesia for Cesarean Delivery | – | Procedure: Spinal Anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The pregnant women and their babies in 01.01.2019 - 31.12.2019.
Key inclusion criteria (1 listed)
- The pregnant women who delivered with cesarean section
Key exclusion criteria (1 listed)
- The pregnant women who delivered with spontan vaginal delivery.
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 |
|---|---|---|
| General AnesthesiaGeneral Anesthesia was intruduced for Cesarean Delivery | Procedure or surgery | General Anesthesia for Cesarean Delivery |
| Spinal AnesthesiaSpinal Anesthesia was intraduced for Cesarean Delivery | Procedure or surgery | Spinal Anesthesia for Cesarean Delivery |
Primary outcome
Apgar 1st minute score
Time frame: 1st minute after birth
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health
Apgar 5th minute score
Time frame: 5th minute after birth
The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health
Umbilical Cord Blood pH
Time frame: at the time of birth
pH values from umblical cord blood sampling
Umbilical Cord Blood PCO2
Time frame: at the time of birth
mmHg
Umbilical Cord Blood HCO3
Time frame: at the time of birth
mEq/L
Umbilical Cord Blood Lactate
Time frame: at the time of birth
mmol/L
Umbilical Cord Blood Base Excess
Time frame: at the time of birth
mEq/L
need for neonatal intensive care
Time frame: up to 24 hours
need for neonatal intensive care
need for maternal intensive care
Time frame: up to 24 hours
need for maternal intensive care
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 22 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Anesthesia for Cesarean Delivery
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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
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Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
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The Role of Preoperative Internal Jugular Vein Collapsibility and Perfusion Index in Predicting Hypotension After Spinal Anesthesia in Elective Cesarean Sections: A Prospective Observational Study
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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.
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 Anesthesia for Cesarean Delivery, run by Istanbul Medeniyet 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 1 inclusion and 1 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 22 Feb 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 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?
Apgar 1st minute score (time frame: 1st minute after birth). The study lists 9 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 22 Feb 2023.