[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602527":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":30,"armGroups":31,"interventions":25,"overallOfficials":25,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":25,"id":61,"slug":25,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":25,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":44,"whyStopped":25,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Campania Luigi Vanvitelli","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":20,"otherOutcomes":25},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"hemoglobin reduction","significant hemoglobin reduction (\\>2 g\u002FdL from pre- to post-delivery)","within 48 hours postpartum",{"measure":14,"description":15,"timeFrame":12},"moderate-to-severe perineal pain","Visual Analog Scale (VAS) ≥ 5; (VAS; range 0-10, where 0 = no pain and 10 = worst imaginable pain); moderate-to-severe pain defined as VAS ≥ 5",{"measure":17,"description":18,"timeFrame":19},"pathological Female Sexual Function Index (FSFI) total score","FSFI total score modification after vaginal laceration Female Sexual Function Index (FSFI total score; range 2-36, where lower scores indicate worse sexual function and higher scores indicate better function), evaluated as change from baseline","within 48 hours after the delivery",[21],{"measure":22,"description":23,"timeFrame":24},"occult perineal or vaginal muscle lesions","occult perineal or vaginal muscle lesions on postpartum perineal ultrasound;","within 7 days postpartum for ultrasound assessment; at 3 months postpartum for FSFI evaluation.",null,{"allocation":25,"interventionModel":25,"interventionModelDescription":25,"primaryPurpose":25,"observationalModel":27,"timePerspective":28,"maskingInfo":25},"COHORT","PROSPECTIVE","Second-degree perineal tears are heterogeneous injuries involving the perineal muscles without anal sphincter involvement, and their anatomical variability may influence postpartum outcomes. Current standard classifications do not provide detailed subclassification, limiting risk stratification.\n\nThis prospective, single-center observational study evaluates the prognostic performance of two detailed classification systems: the Scandinavian classification (based on the extent of the perineal body) and the De Simone classification (based on vaginal extension and muscle involvement).\n\nParticipants are consecutively enrolled following spontaneous vaginal delivery with second-degree tears. Classification is performed during routine postpartum examination by trained clinicians using both systems, with independent assessment to minimize misclassification.\n\nData are collected prospectively and managed in a secure electronic database with predefined validation and consistency checks. Source data verification is performed against clinical records, and variables are standardized through a predefined data dictionary.\n\nThe statistical approach includes multivariable modeling to assess the association between tear subtypes and clinical outcomes, adjusting for relevant confounders. Model performance will be evaluated using standard calibration and discrimination metrics, with predefined strategies for handling missing data.\n\nThe study is non-interventional and conducted in accordance with Good Clinical Practice.","Women giving birth, who experience a spontaneous vaginal delivery resulting in a spontaneous second-degree perineal tear. Participants are recruited consecutively from the hospital's maternity ward during the study period.",[32],{"label":33,"type":25,"description":34,"interventionNames":25},"Women with spontaneous second-degree perineal tears","Participants are women who have a spontaneous vaginal birth and sustain a spontaneous second-degree perineal tear. Each tear is classified according to both the Scandinavian (Macedo et al., 2022) and De Simone systems during routine postpartum examination. No experimental intervention is performed; outcomes are collected through clinical records, postpartum examination, ultrasound, and validated questionnaires (FSFI).",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Marco La Verde, MD, researcher","CONTACT","+393389412266","marco.laverde@unicampania.it",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":46,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Universita degli studi della Campania \"Luigi Vanvitelli\" - dipartimento della donna, bambino e chirurgia generale e specialistica,","RECRUITING","Naples","Italy","80138","IT",{"type":50,"coordinates":51},"Point",[52,53],14.26811,40.85216,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Marco La Verde","Researcher","100602527",false,"NCT07124676","Prospective Study Comparing Two Classification Systems for Second-degree Vaginal Tears During Spontaneous Childbirth to Assess Their Ability to Predict Postpartum Complications.","Prospective Observational Study Comparing Two Classifications of Second-degree Perineal Tears in Spontaneous Vaginal Births, to Evaluate Their Correlation With Postpartum Clinical Outcomes.","LAC-VAG-2025","Inclusion Criteria:\n\n* Female at birth\n* Age ≥ 18 years\n* Spontaneous vaginal delivery\n* Presence of a spontaneous second-degree perineal tear confirmed on -postpartum examination\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Obstetric or medical conditions preventing spontaneous vaginal delivery\n* Inability to understand study procedures or complete follow-up assessments","FEMALE","18 Years",{"count":71,"type":72},482,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether different classification systems for second-degree perineal tears can predict postpartum complications in women undergoing spontaneous vaginal childbirth. The main questions it aims to answer are:\n\nDoes the Scandinavian classification better predict postpartum complications such as hemoglobin drop, perineal pain, occult muscle injury, and sexual dysfunction? Does the De Simone classification better correlate with these same postpartum outcomes?\n\nResearchers will compare the Scandinavian classification and the De Simone classification to see which system more accurately predicts clinically relevant postpartum complications.\n\nParticipants will:\n\nUndergo standard clinical assessment after spontaneous vaginal delivery with a second-degree perineal tear Have their perineal tear classified using both the Scandinavian and De Simone systems Receive routine postpartum evaluation, including hemoglobin measurement, pain assessment (VAS), and perineal ultrasound Complete follow-up assessment of sexual function using the Female Sexual Function Index (FSFI)",[76],"Vaginal Laceration During Delivery",[78,79],"vaginal laceration","delivery","2026-04-22",{"date":82,"type":83},"2026-04-28","ACTUAL",{"date":85,"type":83},"2025-11-04",{"date":87,"type":72},"2028-10-01",{"name":5,"class":6},1]