NCT07477093

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2023

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

January 21, 2026

Last Update Submit

March 13, 2026

Conditions

Neonatal Cerebral OxygenationCesarean Section

Keywords

Neonatal cerebral oxygenationCesarean sectionNIRSGeneral anesthesiaSpinal anesthesiacFTOENear-infrared spectroscopyRegional cerebral oxygen saturationNeonate

Outcome Measures

Primary Outcomes (1)

  • 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.

    From birth to 16 minutes after delivery.

Secondary Outcomes (7)

  • Umbilical Cord Blood Gas Parameters

    At delivery

  • Cerebral Fractional Tissue Oxygen Extraction (cFTOE)

    From birth to 16 minutes after delivery.

  • Neonatal Heart Rate (HR)

    From birth to 16 minutes after delivery

  • Neonatal Peripheral Oxygen Saturation (SpO₂)

    From birth to 16 minutes after delivery

  • Umbilical Cord Blood Gas Parameters

    At delivery

  • +2 more secondary outcomes

Study Arms (2)

Spinal Anesthesia Group

Pregnant women undergoing elective cesarean section under spinal anesthesia (observational exposure)

Other: No intervention (observational study)

General Anesthesia Group

Pregnant women undergoing elective cesarean section under general anesthesia (observational exposure).

Other: No intervention (observational study)

Interventions

No intervention (observational study)OTHER

No intervention - observational study only.

General Anesthesia GroupSpinal Anesthesia Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Multiple gestation
  • Placental implantation or adhesion anomalies
  • Neonates requiring resuscitation or supplemental oxygen after birth
  • Maternal intraoperative desaturation requiring oxygen supplementation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Hospital

Antalya, 07070, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 23972642RESULT

  • Willfurth 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.

    PMID: 31096224RESULT

  • Pichler 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.

    PMID: 28280719RESULT

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

January 21, 2026

First Posted

March 17, 2026

Study Start

January 2, 2020

Primary Completion

January 2, 2023

Study Completion

January 2, 2023

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)