Neonatal Cerebral OxygenationNEO-OXY-CSNCT07477093
Effects of Spinal Versus General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section
An observational study of Neonatal Cerebral Oxygenation and Cesarean Section, run by Akdeniz University Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study evaluates and compares the effects of spinal and general anesthesia techniques used during elective cesarean section on neonatal cerebral regional oxygen saturation (crSO₂) during the early transition to extrauterine life. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Cerebral Oxygenation, Cesarean Section
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2020to 2 Jan 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy pregnant women undergoing elective cesarean section and their neonates were included. Anesthesia type was determined by routine clinical practice. Neonatal cerebral oxygenation was monitored during early postnatal transition.
Who may be able to join
- Pregnant women aged 18-40 years
- ASA physical status II
- Gestational age between 36 and 41 weeks
- Undergoing elective cesarean section
- Singleton pregnancy
- Provided written and verbal informed consent
Who cannot join
- Emergency cesarean delivery
- ASA physical status ≥ III
- Smoking or alcohol use
- Presence of chronic systemic disease
- Preeclampsia, eclampsia, or other pregnancy-related complications
- Preterm (<36 weeks) or post-term (>41 weeks) pregnancy
Show all 10Show fewer
- Multiple gestation
- Placental implantation or adhesion anomalies
- Neonates requiring resuscitation or supplemental oxygen after birth
- Maternal intraoperative desaturation requiring oxygen supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Spinal and General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section
This prospective observational study evaluates and compares the effects of spinal and general anesthesia techniques used during elective cesarean section on neonatal cerebral regional oxygen saturation (crSO₂) during the early transition to extrauterine life. Near-infrared spectroscopy (NIRS) was used to continuously monitor neonatal cerebral oxygenation for the first 16 minutes after birth. Neonatal heart rate, peripheral oxygen saturation (SpO₂), cerebral fractional tissue oxygen extraction (cFTOE), umbilical cord blood gas parameters, birth weight, and APGAR scores were also recorded.
Read the detailed description
The transition from intrauterine to extrauterine life represents a critical period for neonatal cerebral oxygenation. Both spinal and general anesthesia may influence maternal hemodynamics and placental perfusion, potentially affecting neonatal oxygen delivery. This prospective observational clinical study was conducted between January 2020 and January 2023 after approval by the Akdeniz University Faculty of Medicine Clinical Research Ethics Committee. Forty-nine pregnant women aged 18-40 years with ASA physical status II and gestational age between 36 and 41 weeks who underwent elective cesarean delivery were enrolled. Participants were allocated into two groups based on anesthesia technique: spinal anesthesia (n=29) and general anesthesia (n=20).
Neonates were monitored immediately after birth using near-infrared spectroscopy with a sensor placed on the right frontal region. Cerebral regional oxygen saturation (crSO₂) was recorded at 2-minute intervals for 16 minutes. Simultaneously, neonatal heart rate and peripheral oxygen saturation were measured. Cerebral fractional tissue oxygen extraction (cFTOE) was calculated. Umbilical cord blood gas analysis, neonatal birth weight, and 1st- and 5th-minute APGAR scores were recorded. Primary analyses compared neonatal cerebral oxygenation parameters between anesthesia groups. Secondary analyses evaluated the effect of maternal hypotension requiring vasopressor treatment on neonatal cerebral oxygenation.
- Conditions
- Neonatal Cerebral Oxygenation, Cesarean Section
- Being tested
- No intervention (observational study)
- Keywords
- Neonatal cerebral oxygenation, Cesarean section, NIRS, General anesthesia, Spinal anesthesia, cFTOE, Near-infrared spectroscopy, Regional cerebral oxygen saturation, Neonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No intervention - observational study only.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia Group | Pregnant women undergoing elective cesarean section under spinal anesthesia (observational exposure) Receives: Other: No intervention (observational study) | |
| General Anesthesia Group | Pregnant women undergoing elective cesarean section under general anesthesia (observational exposure). Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Cerebral Regional Oxygen Saturation (crSO₂)
Cerebral regional oxygen saturation measured non-invasively using near-infrared spectroscopy (NIRS) with a sensor placed on the right frontal region. Measurements were recorded at 2-minute intervals during the first 16 minutes after birth.
Measured: From birth to 16 minutes after delivery.
Secondary outcomes (7)
Umbilical Cord Blood Gas Parameters
Umbilical cord blood gas analysis showing pH measured immediately after delivery.
Measured: At delivery
Cerebral Fractional Tissue Oxygen Extraction (cFTOE)
Calculated from cerebral regional oxygen saturation and peripheral oxygen saturation values during the first 16 minutes after birth.
Measured: From birth to 16 minutes after delivery.
Neonatal Heart Rate (HR)
Heart rate measured continuously using pulse oximetry during the first 16 minutes after birth.
Measured: From birth to 16 minutes after delivery
Neonatal Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation measured continuously using pulse oximetry on the right hand during the first 16 minutes after birth
Measured: From birth to 16 minutes after delivery
Umbilical Cord Blood Gas Parameters
Umbilical cord blood gas analysis including pO₂ measured immediately after delivery.
Measured: At delivery
Umbilical Cord Blood Gas Parameters
Umbilical cord blood gas analysis including pCO₂ measured immediately after delivery
Measured: At delivery
Umbilical Cord Blood Gas Parameters
Umbilical cord blood gas analysis including lactate measured immediately after delivery.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start2 Jan 2020
- Primary completion2 Jan 2023
- Study completion2 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Neonatal Cerebral OxygenationStudies 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge KARSLI, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477093
- Sponsor's protocol ID
- Akdeniz-ETHICS-193
- Acronym
- NEO-OXY-CS
- Status last verified
- Mar 2026
- First submitted
- 21 Jan 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pichler G, Binder C, Avian A, Beckenbach E, Schmolzer GM, Urlesberger B. Reference ranges for regional cerebral tissue oxygen saturation and fractional oxygen extraction in neonates during immediate transition after birth. J Pediatr. 2013 Dec;163(6):1558-63. doi: 10.1016/j.jpeds.2013.07.007. Epub 2013 Aug 22.
PubMed 23972642Willfurth I, Baik-Schneditz N, Schwaberger B, Mileder L, Schober L, Urlesberger B, Pichler G. Cerebral Oxygenation in Neonates Immediately after Cesarean Section and Mode of Maternal Anesthesia. Neonatology. 2019;116(2):132-139. doi: 10.1159/000499046. Epub 2019 May 16.
PubMed 31096224Pichler G, Schmolzer GM, Urlesberger B. Cerebral Tissue Oxygenation during Immediate Neonatal Transition and Resuscitation. Front Pediatr. 2017 Feb 23;5:29. doi: 10.3389/fped.2017.00029. eCollection 2017.
PubMed 28280719
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Spinal and General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section
- ClinicalTrials.gov ID
- NCT07477093
- Acronym / sponsor ID
- NEO-OXY-CS / Akdeniz-ETHICS-193
- Conditions
- Neonatal Cerebral Oxygenation, Cesarean Section
- Keywords
- Neonatal cerebral oxygenation, Cesarean section, NIRS, General anesthesia, Spinal anesthesia, cFTOE, Near-infrared spectroscopy, Regional cerebral oxygen saturation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Akdeniz University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 2 Jan 2023 (actual)
- Study completion
- 2 Jan 2023 (actual)
- First posted
- 17 Mar 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 prospective observational study evaluates and compares the effects of spinal and general anesthesia techniques used during elective cesarean section on neonatal cerebral regional oxygen saturation (crSO₂) during the early transition to extrauterine life. Near-infrared spectroscopy (NIRS) was used to continuously monitor neonatal cerebral oxygenation for the first 16 minutes after birth. Neonatal heart rate, peripheral oxygen saturation (SpO₂), cerebral fractional tissue oxygen extraction (cFTOE), umbilical cord blood gas parameters, birth weight, and APGAR scores were also recorded.
Detailed description
The transition from intrauterine to extrauterine life represents a critical period for neonatal cerebral oxygenation. Both spinal and general anesthesia may influence maternal hemodynamics and placental perfusion, potentially affecting neonatal oxygen delivery. This prospective observational clinical study was conducted between January 2020 and January 2023 after approval by the Akdeniz University Faculty of Medicine Clinical Research Ethics Committee. Forty-nine pregnant women aged 18-40 years with ASA physical status II and gestational age between 36 and 41 weeks who underwent elective cesarean delivery were enrolled. Participants were allocated into two groups based on anesthesia technique: spinal anesthesia (n=29) and general anesthesia (n=20).
Neonates were monitored immediately after birth using near-infrared spectroscopy with a sensor placed on the right frontal region. Cerebral regional oxygen saturation (crSO₂) was recorded at 2-minute intervals for 16 minutes. Simultaneously, neonatal heart rate and peripheral oxygen saturation were measured. Cerebral fractional tissue oxygen extraction (cFTOE) was calculated. Umbilical cord blood gas analysis, neonatal birth weight, and 1st- and 5th-minute APGAR scores were recorded. Primary analyses compared neonatal cerebral oxygenation parameters between anesthesia groups. Secondary analyses evaluated the effect of maternal hypotension requiring vasopressor treatment on neonatal cerebral oxygenation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia Group | – | Other: No intervention (observational study)Pregnant women undergoing elective cesarean section under spinal anesthesia (observational exposure) |
| General Anesthesia Group | – | Other: No intervention (observational study)Pregnant women undergoing elective cesarean section under general anesthesia (observational exposure). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy pregnant women undergoing elective cesarean section and their neonates were included. Anesthesia type was determined by routine clinical practice. Neonatal cerebral oxygenation was monitored during early postnatal transition.
Key inclusion criteria (6 listed)
- Pregnant women aged 18-40 years
- ASA physical status II
- Gestational age between 36 and 41 weeks
- Undergoing elective cesarean section
- Singleton pregnancy
Key exclusion criteria (10 listed)
- Emergency cesarean delivery
- ASA physical status ≥ III
- Smoking or alcohol use
- Presence of chronic systemic disease
- Preeclampsia, eclampsia, or other pregnancy-related complications
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 |
|---|---|---|
| No intervention (observational study)No intervention - observational study only. | Other | General Anesthesia Group, Spinal Anesthesia Group |
Primary outcome
Neonatal Cerebral Regional Oxygen Saturation (crSO₂)
Time frame: From birth to 16 minutes after delivery.
Cerebral regional oxygen saturation measured non-invasively using near-infrared spectroscopy (NIRS) with a sensor placed on the right frontal region. Measurements were recorded at 2-minute intervals during the first 16 minutes after birth.
7 secondary outcomes
Umbilical Cord Blood Gas Parameters
Time frame: At delivery
Cerebral Fractional Tissue Oxygen Extraction (cFTOE)
Time frame: From birth to 16 minutes after delivery.
Neonatal Heart Rate (HR)
Time frame: From birth to 16 minutes after delivery
Neonatal Peripheral Oxygen Saturation (SpO₂)
Time frame: From birth to 16 minutes after delivery
Umbilical Cord Blood Gas Parameters
Time frame: At delivery
Umbilical Cord Blood Gas Parameters
Time frame: At delivery
Umbilical Cord Blood Gas Parameters
Time frame: At delivery
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 17 Mar 2026.
- Results publication: PubMed 23972642Pichler G, Binder C, Avian A, Beckenbach E, Schmolzer GM, Urlesberger B. Reference ranges for regional cerebral tissue oxygen saturation and fractional oxygen extraction in neonates during immediate transition after birth. J Pediatr. 2013 Dec;163(6):1558-63. doi: 10.1016/j.jpeds.2013.07.007. Epub 2013 Aug 22.
- Results publication: PubMed 31096224Willfurth I, Baik-Schneditz N, Schwaberger B, Mileder L, Schober L, Urlesberger B, Pichler G. Cerebral Oxygenation in Neonates Immediately after Cesarean Section and Mode of Maternal Anesthesia. Neonatology. 2019;116(2):132-139. doi: 10.1159/000499046. Epub 2019 May 16.
- Results publication: PubMed 28280719Pichler G, Schmolzer GM, Urlesberger B. Cerebral Tissue Oxygenation during Immediate Neonatal Transition and Resuscitation. Front Pediatr. 2017 Feb 23;5:29. doi: 10.3389/fped.2017.00029. eCollection 2017.
- Individual participant dataSharing planned: No
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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 Neonatal Cerebral Oxygenation and Cesarean Section, run by Akdeniz University Hospital 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 6 inclusion and 10 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 17 Mar 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?
Neonatal Cerebral Regional Oxygen Saturation (crSO₂) (time frame: From birth to 16 minutes after delivery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07477093, which also lists 3 linked publications.
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 17 Mar 2026.