[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594934":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":27,"responsibleParty":42,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":10,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"University of Campania Luigi Vanvitelli","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Postpartum Women Screened Within 72 Hours After Delivery",null,"This cohort consists of postpartum women who deliver a live-born infant at ≥35 weeks of gestation and are clinically stable. Participants are screened within 72 hours after childbirth using the Edinburgh Postnatal Depression Scale (EPDS) and the Hamilton Depression Rating Scale (HAM-D). The study includes both women with and without depressive symptoms, allowing comparison within the cohort based on screening results. The purpose is to assess the incidence of postpartum depression and identify associated socio-demographic or obstetric risk factors in a real-world clinical setting",[13],"Diagnostic Test: Standardized Psychological Screening Using EPDS and HAM-D",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Standardized Psychological Screening Using EPDS and HAM-D","Participants will undergo a standardized psychological screening protocol for postpartum depression within 72 hours after delivery. The protocol includes: (1) completion of the Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-administered questionnaire assessing depressive symptoms; and (2) administration of the Hamilton Depression Rating Scale (HAM-D), a 17-item clinician-administered tool for evaluating the severity of depressive symptoms. The combined use of these tools allows early detection and stratification of postpartum depressive symptoms in a clinical population.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Marco La Verde, MD, researcher, PhD student","CONTACT","+393389412266","+39","marco.laverde@unicampania.it",[28],{"facility":29,"status":10,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Largo Madonna delle grazie 1","Naples","80138","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],14.26811,40.85216,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Marco La Verde","M.D., researcher and PhD student","100594934","screening-for-postpartum-depression-using-epds-and-ham-d-in-mothers-within-72-hours-after-delivery-at-a-tertiary-care-center-sos-mamma-study-100594934",false,"NCT07025902","Screening for Postpartum Depression Using EPDS and HAM-D in Mothers Within 72 Hours After Delivery at a Tertiary Care Center (SOS-Mamma Study)","Holistic Support Pathways for Maternal Psychological Wellbeing: A Comprehensive Approach From Preconception to Postpartum (SOS-Mamma).","SOS-Mamma","nclusion Criteria\n\nWomen aged ≥18 and \\\u003C45 years at the time of delivery\n\nSingleton pregnancy at term (≥37 weeks) or late preterm (≥35 weeks of gestation)\n\nLive-born infant in clinically stable condition at discharge\n\nAbility to understand and complete self-reported questionnaires (EPDS) in Italian or English\n\nAbility to provide written informed consent\n\nScreening performed within 72 hours postpartum during routine hospital stay\n\nExclusion Criteria\n\nMultiple pregnancy (e.g., twins or higher-order gestations)\n\nMajor psychiatric diagnosis under active treatment at the time of delivery (e.g., schizophrenia, bipolar disorder)\n\nSevere language barriers preventing adequate understanding of the consent form or questionnaires\n\nNeonatal death or congenital anomalies requiring prolonged NICU admission\n\nMaternal age \\\u003C18 or ≥45 years at delivery\n\nGestational age at birth \\\u003C35 weeks",true,"ALL","18 Years","45 Years",{"count":59,"type":60},273,"ESTIMATED","OBSERVATIONAL","Postpartum depression (PPD) is one of the most common complications affecting maternal mental health after childbirth, with an estimated prevalence of 10-20% in high-income countries. Despite its frequency and the availability of effective screening tools, early diagnosis remains largely underestimated in routine clinical care.\n\nThis study, part of the national SOS-Mamma project funded by the Italian Ministry of Health, aims to systematically screen for signs of postpartum depression in women giving birth at a tertiary care obstetric unit (AOU Vanvitelli - UOC of Obstetrics and Gynecology, Naples, Italy). The goal is to promote early detection and timely referral to specialized care pathways.\n\nThe study is a prospective, observational, monocentric, non-interventional, non-pharmacological study. All eligible women who deliver at the hospital will be invited to participate within the first 72 hours after childbirth. Participants will be asked to complete the Edinburgh Postnatal Depression Scale (EPDS) - a widely used self-report questionnaire - and will undergo a brief clinical interview using the Hamilton Depression Rating Scale (HAM-D), conducted by trained healthcare staff.\n\nThe study's primary objective is to estimate the real-world incidence of postpartum depression within this population. Secondary objectives include identifying socio-demographic and obstetric risk factors associated with depressive symptoms, assessing the acceptability and feasibility of routine screening, and contributing to the development of a replicable model of care aligned with international recommendations (NICE, WHO, ISS).\n\nCollected data will be anonymized and analyzed to provide evidence on early indicators of PPD and guide improvements in clinical care. Women identified as being at risk (e.g., EPDS \\>10 or presence of suicidal ideation) will be referred to specialist psychiatric services in accordance with clinical guidelines.\n\nParticipation in the study is voluntary. All procedures comply with European data protection regulations and Good Clinical Practice (GCP) principles. No experimental treatments are involved, and no changes to standard care will be made based on study participation.\n\nBy highlighting the need for structured mental health screening in the postpartum period, this study hopes to improve maternal wellbeing and reduce the long-term impact of undiagnosed depression on mothers and their children.",[64],"Post Partum Depression",[64,66,67],"EPDS","HAM-D Scales","NOT_YET_RECRUITING","2025-06-17",{"date":71,"type":72},"2025-06-18","ACTUAL",{"date":74,"type":60},"2025-07-15",{"date":76,"type":60},"2027-12-01",{"name":5,"class":6},1]