[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631518":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":56,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":81,"whyStopped":26,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Chengdu Jinjiang Maternity and Child Health Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intranasal Dexmedetomidine Group","EXPERIMENTAL","Participants in this arm will receive a single dose of intranasal dexmedetomidine 50 μg (one spray of 25 μg per nostril, total two sprays) immediately before initiation of Combined Spinal-Epidural labor analgesia. Labor analgesia follows standard protocol using ropivacaine and sufentanil via patient-controlled epidural analgesia pump.",[13],"Drug: Dexmedetomidine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo (Normal Saline) Intranasal","PLACEBO_COMPARATOR","Participants in this arm will receive a single dose of intranasal normal saline (one spray per nostril, total two sprays) immediately before initiation of Combined Spinal-Epidural labor analgesia. Labor analgesia follows standard protocol using ropivacaine and sufentanil via patient-controlled epidural analgesia pump.",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Dexmedetomidine","Intranasal dexmedetomidine 50 μg administered as a single dose immediately before initiation of Combined Spinal-Epidural labor analgesia. The drug is delivered via nasal spray device, with one spray of 25 μg in each nostril (total two sprays). The intervention is prepared and administered by the attending anesthesiologist who is aware of group allocation but does not participate in postoperative follow-up or outcome assessment.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","Intranasal normal saline (one spray per nostril, total two sprays) administered as a single dose before initiation of Combined Spinal-Epidural labor analgesia. Identical in appearance, color, odor, and packaging to the dexmedetomidine nasal spray to maintain blinding.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Bo Liu, MS","CONTACT","+8618502846036","liubojjfy@163.com",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Chengdu Jinjiang District Women & Children Health Hospital,","Chengdu","Sichuan","610011","China","CN",{"type":46,"coordinates":47},"Point",[48,49],104.06667,30.66667,{"lat":49,"lon":48},[52],{"name":53,"role":34,"phone":54,"phoneExt":26,"email":55},"jianjun mao, BS","+8615008460156","anesthesiologyzj@163.com",{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Fei Jia","Director of Anesthesiology Department","100631518","intranasal-dexmedetomidine-for-postpartum-depression-prevention-100631518",false,"NCT07501728","Intranasal Dexmedetomidine for Postpartum Depression Prevention","Intranasal Dexmedetomidine for Prevention of Postpartum Depression in Women Receiving Combined Spinal-Epidural Labor Analgesia: A Randomized Controlled Trial","Inclusion Criteria:\n\n* ASA physical status II or III.\n* Age ≥ 18 years.\n* Singleton pregnancy, cephalic presentation\n* No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia for planned vaginal delivery\n\nExclusion Criteria:\n\n* History of bipolar disorder, psychiatric disorders, or suicidal ideation\n* Severe cardiac, cerebral, hepatic, or renal disease\n* Allergy to α2-adrenergic receptor agonists\n* Baseline bradycardia (heart rate \\\u003C 60 bpm) or cardiac conduction abnormalities before labor analgesia\n* Hypotension (systolic blood pressure \\\u003C 90 mmHg) before labor analgesia\n* History of drug or alcohol abuse\n* Severe rhinitis or nasal cavity deformity","FEMALE","18 Years",{"count":70,"type":71},270,"ESTIMATED","INTERVENTIONAL",[74],"NA","Brief Title: Intranasal Dexmedetomidine for Postpartum Depression Prevention: A Randomized Trial This study aims to evaluate the effect of intranasal dexmedetomidine (Dex) administered before combined spinal-epidural labor analgesia on the incidence of postpartum depression (PPD) in women undergoing vaginal delivery. This prospective, randomized, double-blind, placebo-controlled trial will enroll 270 parturients scheduled for vaginal delivery with neuraxial labor analgesia at Chengdu Jinjiang Maternal and Child Health Hospital from 2026 to 2027. Participants will be randomly assigned in a 1:1 ratio to receive either intranasal Dex (50 μg) or an equal volume of normal saline before the initiation of labor analgesia.\n\nPrimary Outcome Measure:\n\nIncidence of PPD at 42 days postpartum, defined as an Edinburgh Postnatal Depression Scale (EPDS) score ≥ 10\n\nSecondary Outcome Measures:\n\nIncidence of PPD at 7 days postpartum (EPDS ≥ 10) Sleep quality assessed by Numerical Rating Scale (NRS) and incidence of sleep disturbance (NRS ≥ 6) at 7 and 42 days postpartum Analgesic effect: NRS pain scores before labor analgesia and at 30 minutes, 1 hour, and 3 hours after analgesia Sedative effect: Ramsay Sedation Scale scores at the same time points Adverse events: bradycardia, hypotension, nausea\u002Fvomiting, respiratory depression, oversedation, intrapartum fever Labor characteristics: duration of first, second, and third stages of labor, and total labor duration Duration of labor analgesia Mode of delivery: spontaneous vaginal delivery or cesarean section Neonatal outcomes: Apgar scores at 1, 5, and 10 minutes, and NICU admission rate We hypothesize that intranasal Dex administered before labor analgesia will significantly reduce the incidence of PPD at 42 days postpartum compared to placebo. This study is expected to provide a novel, non-invasive, and effective strategy for PPD prevention in women undergoing vaginal delivery, thereby improving maternal mental health and neonatal outcomes.",[77],"Postpartum Depression (PPD)",[79,23,80],"Postpartum Depression","Labor Analgesia","NOT_YET_RECRUITING","2026-03-24",{"date":84,"type":85},"2026-03-30","ACTUAL",{"date":87,"type":71},"2026-05-01",{"date":89,"type":71},"2027-04-01",{"name":5,"class":6},1]