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Anesthesia and Neonatal Outcomes After Cesarean Delivery

General Versus Neuraxial Anesthesia and Early Neonatal Outcomes After Elective and Emergency Cesarean Delivery: A Retrospective Cohort of 21,926 Neonates

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07893808
Enrollment
21926
Registered
2026-10-26
Start date
2026-10-15
Completion date
2026-10-16
Last updated
2026-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Delivery

Keywords

General Anesthesia, Neuraxial Anesthesia, Cesarean Section, Apgar Score, Neonatal Outcomes, Emergency Cesarean Delivery

Brief 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. 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.

Interventions

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.

PROCEDURENeuraxial 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.

Sponsors

Serra Topal
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Days to 1 Days
Healthy volunteers
No

Inclusion criteria

\*\*Inclusion Criteria:\*\* * 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. \*\*

Exclusion criteria

\*\* * 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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of 5-Minute Apgar Score Below 75 minutes after birthProportion 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.

Secondary

MeasureTime frameDescription
Incidence of 1-Minute Apgar Score Below 71 minute after birthProportion 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.
NICU Admission Within 24 Hours After BirthUp to 24 hours after birthProportion 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.
Admission to a Level III Neonatal Intensive Care UnitFrom birth to NICU discharge, up to 174 daysProportion 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.
Invasive Ventilation During NICU AdmissionFrom birth to NICU discharge, up to 174 daysProportion 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.
Non-Invasive Ventilation During NICU AdmissionFrom birth to NICU discharge, up to 174 daysProportion 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.
Length of Neonatal Intensive Care Unit StayFrom birth to NICU discharge, up to 174 daysDuration 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORSerra Topal, MD

Bursa City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 27, 2026