[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658576":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":36,"studyPopulation":26,"armGroups":37,"interventions":49,"overallOfficials":26,"centralContacts":59,"locations":65,"responsibleParty":84,"collaborators":26,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":106,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Second Affiliated Hospital of Wenzhou Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"1. Neonatal hearing screening pass rate by transient evoked otoacoustic emission (TEOAE)","The pass rate of neonatal transient evoked otoacoustic emission (TEOAE) hearing screening within 72 hours after birth.","Within 72 hours after delivery",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"Maternal intraoperative hemodynamic changes","Changes in maternal blood pressure and heart rate during cesarean section.","during surgery",{"measure":19,"description":20,"timeFrame":21},"Neonatal Apgar scores","Apgar scores will be assessed at 1 and 5 minutes after birth. The Apgar score evaluates five components: Appearance, Pulse, Grimace, Activity, and Respiration. The total score ranges from 0 to 10, with higher scores indicating better neonatal condition and a better outcome.","1 minute and 5 minutes after birth",{"measure":23,"description":24,"timeFrame":25},"Postoperative maternal VAS pain score","Postoperative maternal pain intensity will be assessed using the Visual Analog Scale (VAS) at 1, 6, 12, 24, and 48 hours after cesarean delivery. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.","1 hour, 6 hours, 12 hours, 24 hours and 48 hours after surgery",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":6,"observationalModel":26,"timePerspective":26,"maskingInfo":30},"RANDOMIZED","PARALLEL",{"masking":31,"maskingDescription":32,"whoMasked":33},"DOUBLE","Participants are blinded to anesthesia allocation. Anesthesiologists and surgical team are unblinded. All outcome assessors including audiologists, staff collecting hemodynamic data, Apgar scores and VAS pain scores remain blinded to group assignment to reduce bias.",[34,35],"PARTICIPANT","OUTCOMES_ASSESSOR","This is a single-center, prospective, single-blind, parallel-group randomized controlled trial. A total of 144 eligible parturients undergoing cesarean section will be enrolled and randomly allocated in a 1:1 ratio to the combined spinal-epidural anesthesia (CSEA) group or general anesthesia (GA) group. An independent statistician will generate the randomization sequence using a computerized random number table. Allocation concealment will be maintained using sealed, opaque, sequentially numbered envelopes, which will be opened by an independent coordinator after enrollment.\n\nParticipants will not be informed of their assigned anesthesia group. Anesthesia providers and surgical teams will be aware of group assignment. All outcome assessors, including personnel recording hemodynamic data, assessing Apgar scores, performing TEOAE hearing screening, and collecting postoperative VAS pain scores and adverse-event data, will remain blinded to group allocation to reduce assessment bias.\n\nThe investigators will compare maternal intraoperative hemodynamic changes and record the interval from anesthesia administration to neonatal delivery. Neonatal Apgar scores will be recorded at 1 and 5 minutes. Maternal postoperative Visual Analogue Scale (VAS) pain scores will be collected at 1, 6, 12, 24, and 48 hours after surgery. Neonatal hearing outcomes will include initial and repeat transient evoked otoacoustic emission (TEOAE) screening results. Infants who fail repeat screening will undergo further hearing assessment at 3-6 months of age to identify hearing loss.",[38,44],{"label":39,"type":40,"description":41,"interventionNames":42},"Combined Spinal-Epidural Anesthesia Group (CSEA Group)","ACTIVE_COMPARATOR","Participants receive combined spinal-epidural anesthesia for elective cesarean section. Intraoperative hemodynamic parameters, time from anesthesia initiation to fetal delivery, neonatal Apgar scores, postoperative VAS pain scores and neonatal TEOAE hearing screening results will be collected.",[43],"Procedure: Combined spinal-epidural anesthesia",{"label":45,"type":40,"description":46,"interventionNames":47},"General Anesthesia Group (GA Group)","Participants receive general anesthesia for elective cesarean section. The same set of maternal and neonatal indicators will be collected and compared with the CSEA group.",[48],"Procedure: General Anesthesia (GA)",[50,55],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":26},"PROCEDURE","Combined spinal-epidural anesthesia","Combined spinal-epidural anesthesia is administered for elective cesarean section according to the study protocol",[39],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":26},"General Anesthesia (GA)","General anesthesia performed for cesarean delivery",[45],[60],{"name":61,"role":62,"phone":63,"phoneExt":26,"email":64},"Baiping Mao, PhD","CONTACT","+860577-85676879","baipingmaowmu@163.com",[66],{"facility":67,"status":68,"city":69,"state":26,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"The Second Affiliated Hospital of Wenzhou Medical University","RECRUITING","Wenzhou","325000","China","CN",{"type":74,"coordinates":75},"Point",[76,77],120.66682,27.99942,{"lat":77,"lon":76},[80],{"name":81,"role":62,"phone":82,"phoneExt":26,"email":83},"Mingpin Hu, MD","+860577-85676442","Hmp2008mz@163.com",{"type":85,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100658576","comparison-of-different-anesthetic-techniques-on-hearing-outcomes-in-neonates-after-cesarean-delivery-100658576",false,"NCT07852624","Comparison of Different Anesthetic Techniques on Hearing Outcomes in Neonates After Cesarean Delivery","ATHNCD","Inclusion Criteria:(a) Singleton pregnancy with gestational age 37-42 weeks; (b) Maternal age 18-35 years; (c) American Society of Anesthesiologists (ASA) physical status II; (d) Scheduled for elective cesarean delivery based on clinical indications; (e) Written informed consent obtained from the parturient and her family.\n\nExclusion Criteria:\n\n1. Refusal to participate;\n2. Contraindications to neuraxial anesthesia;\n3. Severe comorbidities, including hypertensive disorders of pregnancy, cardiovascular disease, hepatic or renal dysfunction, or coagulation abnormalities;\n4. History of psychiatric disorders, severe anxiety or depression, or chronic preoperative use of sedative or analgesic medications;\n5. Neonatal hyperbilirubinemia or birth weight \\\u003C2,500 g;\n6. Anticipated intraoperative conditions that would prevent completion of the study per the prespecified protocol.","FEMALE","18 Years","35 Years",{"count":97,"type":98},144,"ESTIMATED","INTERVENTIONAL",[101],"NA","This is a single-center, prospective, single-blind randomized controlled trial. The investigators plan to recruit 144 pregnant women scheduled for cesarean delivery. Participants will be randomly assigned to receive either combined spinal-epidural anesthesia (CSEA) or general anesthesia (GA). The study aims to compare the effects of these two anesthetic techniques on neonatal hearing after cesarean delivery. The investigators will collect neonatal transient evoked otoacoustic emission (TEOAE) screening results and conduct follow-up hearing assessments at 3-6 months of age for infants who fail repeat screening. The investigators will also record maternal intraoperative hemodynamic changes, the interval from anesthesia initiation to neonatal delivery, neonatal Apgar scores at 1 and 5 minutes, and maternal postoperative pain scores at multiple time points.",[104,105],"Pregnancy","Neonatal Hearing Function",[107,52,108,109,110],"Cesarean section","General anesthesia","Neonatal hearing","Transient evoked otoacoustic emission","2026-10-05",{"date":113,"type":114},"2026-10-08","ACTUAL",{"date":116,"type":114},"2025-08-02",{"date":118,"type":98},"2026-10-25",{"name":5,"class":6},1]