Cesarean DeliveryNCT07893808
Anesthesia and Neonatal Outcomes After Cesarean Delivery
An observational study of Cesarean Delivery, run by Serra Topal at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study examines the association between the type of anesthesia used during cesarean delivery and early neonatal outcomes. The study includes newborns delivered by cesarean section at Bursa City Hospital between January 2020 and September 2026. Read more about this study
- Who is it for?
- Ages 0 days to 1 day
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- General Anesthesia (GA) and Neuraxial Anesthesia (NA)
- Type of treatment
- Surgery or procedure
- How many people
- 21,926 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2026to 16 Oct 2026
- 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 0 days to 1 day
- All sexes
- No healthy volunteers
- Child
Study population: The study population comprised 21,926 singleton live-born neonates delivered by elective or emergency cesarean section at Bursa City Hospital, Türkiye, between 1 January 2020 and 30 September 2026. All eligible neonates with a gestational age of at least 24 weeks, a classifiable maternal anesthetic technique (general or neuraxial anesthesia), and a valid 5-minute Apgar score were included. Maternal, anesthetic, delivery, and neonatal data were retrospectively obtained from hospital electronic records. No interventions were assigned by the investigators.
Who may be able to join
- Singleton live-born neonates delivered by elective or emergency cesarean section at Bursa City Hospital between 1 January 2020 and 30 September 2026.
- Gestational age of at least 24 completed weeks.
- Classifiable maternal anesthetic technique (general or neuraxial anesthesia).
- Availability of a valid 5-minute Apgar score.
Who cannot join
- Multiple pregnancies, including uncoded twin deliveries identified during data review.
- Intrauterine or intrapartum fetal death.
- Gestational age below 24 completed weeks.
- Missing or implausible gestational age.
- Missing or invalid 5-minute Apgar score.
- Records incorrectly coded as vaginal delivery.
- Records with implausible or invalid clinical data identified during data-quality review.
- Gestational age beyond 42 weeks and 6 days, for which small-for-gestational-age status could not be determined.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: General Versus Neuraxial Anesthesia and Early Neonatal Outcomes After Elective and Emergency Cesarean Delivery: A Retrospective Cohort of 21,926 Neonates
This retrospective observational study examines the association between the type of anesthesia used during cesarean delivery and early neonatal outcomes. The study includes newborns delivered by cesarean section at Bursa City Hospital between January 2020 and September 2026.
The investigators compare general anesthesia with neuraxial anesthesia (spinal, epidural, or combined spinal-epidural) in elective and emergency cesarean deliveries.
Read more
The primary outcome is a five-minute Apgar score below 7. Secondary outcomes include a one-minute Apgar score below 7, NICU admission within 24 hours after birth, and level of care, respiratory support and length of stay during that admission.
The study uses existing hospital records. No additional procedures or interventions are performed. The findings may help clarify how anesthesia type and the urgency of cesarean delivery are associated with early neonatal outcomes.
- Conditions
- Cesarean Delivery
- Being tested
- General Anesthesia (GA), Neuraxial Anesthesia (NA)
- Keywords
- General Anesthesia, Neuraxial Anesthesia, Cesarean Section, Apgar Score, Neonatal Outcomes, Emergency Cesarean Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General Anesthesia (GA)Procedure or surgery
General anesthesia administered during elective or emergency cesarean delivery as part of routine clinical care. Anesthesia was not assigned by the investigators. Exposure to general anesthesia and associated neonatal outcomes were evaluated retrospectively using hospital records.
Neuraxial Anesthesia (NA)Procedure or surgery
Neuraxial anesthesia, including spinal, epidural, or combined spinal-epidural anesthesia, administered during elective or emergency cesarean delivery as part of routine clinical care. Anesthesia was not assigned by the investigators. Maternal anesthesia type and neonatal outcomes were evaluated retrospectively using hospital records.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia (GA) | Newborns delivered by elective or emergency cesarean section under general anesthesia. Maternal anesthesia type and early neonatal outcomes were evaluated retrospectively using hospital records. Receives: Procedure: General Anesthesia (GA) | |
| Neuraxial Anesthesia (NA) | Newborns delivered by elective or emergency cesarean section under neuraxial anesthesia, including spinal, epidural, or combined spinal-epidural anesthesia. Maternal anesthesia type and early neonatal outcomes were evaluated retrospectively using hospital records. Receives: Procedure: Neuraxial Anesthesia (NA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 5-Minute Apgar Score Below 7
Proportion of live-born neonates with an Apgar score below 7 at 5 minutes after birth, compared between general and neuraxial anesthesia groups and evaluated separately for elective and emergency cesarean deliveries.
Measured: 5 minutes after birth
Secondary outcomes (6)
Incidence of 1-Minute Apgar Score Below 7
Proportion of live-born neonates with an Apgar score below 7 at 1 minute after birth, compared between general and neuraxial anesthesia groups and evaluated separately for elective and emergency cesarean deliveries.
Measured: 1 minute after birth
NICU Admission Within 24 Hours After Birth
Proportion of neonates admitted to the study hospital's neonatal intensive care unit (NICU) or transferred to an external NICU within 24 hours after birth. Transfers to external NICUs were included in this outcome.
Measured: Up to 24 hours after birth
Admission to a Level III Neonatal Intensive Care Unit
Proportion of neonates admitted to a Level III NICU during an admission initiated within 24 hours after birth. This outcome was assessed only for infants who remained at the study hospital because post-transfer information from external hospitals was unavailable.
Measured: From birth to NICU discharge, up to 174 days
Invasive Ventilation During NICU Admission
Proportion of neonates with tracheal intubation or mechanical ventilation recorded during a NICU admission that began within 24 hours after birth. This outcome was assessed only for infants who remained at the study hospital. The timing of ventilation within the admission was not recorded.
Measured: From birth to NICU discharge, up to 174 days
Non-Invasive Ventilation During NICU Admission
Proportion of neonates receiving non-invasive ventilation during a NICU admission that began within 24 hours after birth. Only infants who remained at the study hospital were included because post-transfer information was unavailable. The timing of ventilation within the admission was not recorded.
Measured: From birth to NICU discharge, up to 174 days
Length of Neonatal Intensive Care Unit Stay
Duration of NICU stay, measured in days, among neonates admitted to the study hospital's NICU. Infants transferred to external hospitals were excluded because complete post-transfer hospitalization data were unavailable.
Measured: From birth to NICU discharge, up to 174 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start15 Oct 2026
- Primary completion16 Oct 2026
- Study completion16 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serra Topal
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Serra Topal, Bursa City Hospital
- Investigators
- Serra Topal, MD, Principal investigator, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07893808
- Sponsor's protocol ID
- BSHNEO2026
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study is based on retrospective maternal and neonatal hospital records containing confidential clinical information. Data sharing is restricted to protect patient privacy and confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- General Versus Neuraxial Anesthesia and Early Neonatal Outcomes After Elective and Emergency Cesarean Delivery: A Retrospective Cohort of 21,926 Neonates
- ClinicalTrials.gov ID
- NCT07893808
- Acronym / sponsor ID
- BSHNEO2026
- Conditions
- Cesarean Delivery
- Keywords
- General Anesthesia, Neuraxial Anesthesia, Cesarean Section, Apgar Score, Neonatal Outcomes, Emergency Cesarean Delivery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,926 participants (actual)
- Lead sponsor
- Serra TopalOther government
- Study start
- 15 Oct 2026 (actual)
- Primary completion
- 16 Oct 2026 (actual)
- Study completion
- 16 Oct 2026 (actual)
- First posted
- 26 Oct 2026 (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.
This retrospective observational study examines the association between the type of anesthesia used during cesarean delivery and early neonatal outcomes. The study includes newborns delivered by cesarean section at Bursa City Hospital between January 2020 and September 2026.
The investigators compare general anesthesia with neuraxial anesthesia (spinal, epidural, or combined spinal-epidural) in elective and emergency cesarean deliveries.
The primary outcome is a five-minute Apgar score below 7. Secondary outcomes include a one-minute Apgar score below 7, NICU admission within 24 hours after birth, and level of care, respiratory support and length of stay during that admission.
The study uses existing hospital records. No additional procedures or interventions are performed. The findings may help clarify how anesthesia type and the urgency of cesarean delivery are associated with early neonatal outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia (GA) | – | Procedure: General Anesthesia (GA)Newborns delivered by elective or emergency cesarean section under general anesthesia. Maternal anesthesia type and early neonatal outcomes were evaluated retrospectively using hospital records. |
| Neuraxial Anesthesia (NA) | – | Procedure: Neuraxial Anesthesia (NA)Newborns delivered by elective or emergency cesarean section under neuraxial anesthesia, including spinal, epidural, or combined spinal-epidural anesthesia. Maternal anesthesia type and early neonatal outcomes were evaluated retrospectively using hospital records. |
Who may qualify
- Ages
- 0 days to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population comprised 21,926 singleton live-born neonates delivered by elective or emergency cesarean section at Bursa City Hospital, Türkiye, between 1 January 2020 and 30 September 2026. All eligible neonates with a gestational age of at least 24 weeks, a classifiable maternal anesthetic technique (general or neuraxial anesthesia), and a valid 5-minute Apgar score were included. Maternal, anesthetic, delivery, and neonatal data were retrospectively obtained from hospital electronic records. No interventions were assigned by the investigators.
Key inclusion criteria (4 listed)
- Singleton live-born neonates delivered by elective or emergency cesarean section at Bursa City Hospital between 1 January 2020 and 30 September 2026.
- Gestational age of at least 24 completed weeks.
- Classifiable maternal anesthetic technique (general or neuraxial anesthesia).
- Availability of a valid 5-minute Apgar score.
Key exclusion criteria (8 listed)
- Multiple pregnancies, including uncoded twin deliveries identified during data review.
- Intrauterine or intrapartum fetal death.
- Gestational age below 24 completed weeks.
- Missing or implausible gestational age.
- Missing or invalid 5-minute Apgar score.
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 Anesthesia (GA)General anesthesia administered during elective or emergency cesarean delivery as part of routine clinical care. Anesthesia was not assigned by the investigators. Exposure to general anesthesia and associated neonatal outcomes were evaluated retrospectively using hospital records. | Procedure or surgery | General Anesthesia (GA) |
| Neuraxial Anesthesia (NA)Neuraxial anesthesia, including spinal, epidural, or combined spinal-epidural anesthesia, administered during elective or emergency cesarean delivery as part of routine clinical care. Anesthesia was not assigned by the investigators. Maternal anesthesia type and neonatal outcomes were evaluated retrospectively using hospital records. | Procedure or surgery | Neuraxial Anesthesia (NA) |
Primary outcome
Incidence of 5-Minute Apgar Score Below 7
Time frame: 5 minutes after birth
Proportion of live-born neonates with an Apgar score below 7 at 5 minutes after birth, compared between general and neuraxial anesthesia groups and evaluated separately for elective and emergency cesarean deliveries.
6 secondary outcomes
Incidence of 1-Minute Apgar Score Below 7
Time frame: 1 minute after birth
NICU Admission Within 24 Hours After Birth
Time frame: Up to 24 hours after birth
Admission to a Level III Neonatal Intensive Care Unit
Time frame: From birth to NICU discharge, up to 174 days
Invasive Ventilation During NICU Admission
Time frame: From birth to NICU discharge, up to 174 days
Non-Invasive Ventilation During NICU Admission
Time frame: From birth to NICU discharge, up to 174 days
Length of Neonatal Intensive Care Unit Stay
Time frame: From birth to NICU discharge, up to 174 days
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 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study is based on retrospective maternal and neonatal hospital records containing confidential clinical information. Data sharing is restricted to protect patient privacy and confidentiality.
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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.
Serra Topal, MD principal investigator
Bursa City Hospital
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 Delivery, run by Serra Topal 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 4 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 26 Oct 2026. 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?
Incidence of 5-Minute Apgar Score Below 7 (time frame: 5 minutes after birth). 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 26 Oct 2026.