Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:55 AM
Study NCT ID:
NCT07477093
Status:
COMPLETED
Last Update Posted:
2026-03-17
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Spinal Versus General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-03-13', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal Cerebral Regional Oxygen Saturation (crSO₂)', 'timeFrame': 'From birth to 16 minutes after delivery.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Umbilical Cord Blood Gas Parameters', 'timeFrame': 'At delivery', 'description': 'Umbilical cord blood gas analysis showing pH measured immediately after delivery.'}, {'measure': 'Cerebral Fractional Tissue Oxygen Extraction (cFTOE)', 'timeFrame': 'From birth to 16 minutes after delivery.', 'description': 'Calculated from cerebral regional oxygen saturation and peripheral oxygen saturation values during the first 16 minutes after birth.'}, {'measure': 'Neonatal Heart Rate (HR)', 'timeFrame': 'From birth to 16 minutes after delivery', 'description': 'Heart rate measured continuously using pulse oximetry during the first 16 minutes after birth.'}, {'measure': 'Neonatal Peripheral Oxygen Saturation (SpO₂)', 'timeFrame': 'From birth to 16 minutes after delivery', 'description': 'Peripheral oxygen saturation measured continuously using pulse oximetry on the right hand during the first 16 minutes after birth'}, {'measure': 'Umbilical Cord Blood Gas Parameters', 'timeFrame': 'At delivery', 'description': 'Umbilical cord blood gas analysis including pO₂ measured immediately after delivery.'}, {'measure': 'Umbilical Cord Blood Gas Parameters', 'timeFrame': 'At delivery', 'description': 'Umbilical cord blood gas analysis including pCO₂ measured immediately after delivery'}, {'measure': 'Umbilical Cord Blood Gas Parameters', 'timeFrame': 'At delivery', 'description': 'Umbilical cord blood gas analysis including lactate measured immediately after delivery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neonatal cerebral oxygenation', 'Cesarean section', 'NIRS', 'General anesthesia', 'Spinal anesthesia', 'cFTOE', 'Near-infrared spectroscopy', 'Regional cerebral oxygen saturation', 'Neonate'], 'conditions': ['Neonatal Cerebral Oxygenation', 'Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '23972642', 'type': 'RESULT', 'citation': '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': '31096224', 'type': 'RESULT', 'citation': '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': '28280719', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nNeonates 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women aged 18-40 years\n* ASA physical status II\n* Gestational age between 36 and 41 weeks\n* Undergoing elective cesarean section\n* Singleton pregnancy\n* Provided written and verbal informed consent\n\nExclusion Criteria:\n\n* Emergency cesarean delivery\n* ASA physical status ≥ III\n* Smoking or alcohol use\n* Presence of chronic systemic disease\n* Preeclampsia, eclampsia, or other pregnancy-related complications\n* Preterm (\\<36 weeks) or post-term (\\>41 weeks) pregnancy\n* Multiple gestation\n* Placental implantation or adhesion anomalies\n* Neonates requiring resuscitation or supplemental oxygen after birth\n* Maternal intraoperative desaturation requiring oxygen supplementation'}, 'identificationModule': {'nctId': 'NCT07477093', 'acronym': 'NEO-OXY-CS', 'briefTitle': 'Effects of Spinal Versus General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University Hospital'}, 'officialTitle': 'Evaluation of the Effects of Spinal and General Anesthesia on Neonatal Cerebral Oxygenation During Cesarean Section', 'orgStudyIdInfo': {'id': 'Akdeniz-ETHICS-193'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Spinal Anesthesia Group', 'description': 'Pregnant women undergoing elective cesarean section under spinal anesthesia (observational exposure)', 'interventionNames': ['Other: No intervention (observational study)']}, {'label': 'General Anesthesia Group', 'description': 'Pregnant women undergoing elective cesarean section under general anesthesia (observational exposure).', 'interventionNames': ['Other: No intervention (observational study)']}], 'interventions': [{'name': 'No intervention (observational study)', 'type': 'OTHER', 'description': 'No intervention - observational study only.', 'armGroupLabels': ['General Anesthesia Group', 'Spinal Anesthesia Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07070', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University Hospital', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Bilge KARSLI', 'investigatorAffiliation': 'Akdeniz University Hospital'}}}}