[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659498":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":46,"overallOfficials":30,"centralContacts":51,"locations":57,"responsibleParty":70,"collaborators":30,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":30,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":30,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":59,"whyStopped":30,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"University Hospital Hradec Kralove","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":30},[9,13],{"measure":10,"description":11,"timeFrame":12},"Change of anal incontinence","Can structured obstetric training decrease the incidence of postpartum anal incontinence?","Evaluation of QoL as well as US markers will be conducted at 3 months after delivery.",{"measure":14,"description":15,"timeFrame":12},"Change of stress urinary incontinence","Does the intervention reduce the frequency of postpartum stress urinary incontinence?",[17,21,24,27],{"measure":18,"description":19,"timeFrame":20},"Levator ani avulsion assessed by ultrasound","Levator ani avulsion will be assessed using 4D transperineal ultrasound (TPUS). The levator-urethra gap (LUG) will be measured according to the established ultrasound protocol. A LUG \\>25 mm will be considered pathological and indicative of levator ani avulsion.","3 months after delivery",{"measure":22,"description":23,"timeFrame":20},"Urethral mobility and urethral descent assessed by ultrasound","Urethral mobility and descent will be assessed using 2D transperineal ultrasound at rest and during maximal Valsalva manoeuvre. Urethral mobility will be assessed based on the change in the angle of the mid-urethral axis between rest and maximal Valsalva. A change of \\>30° will be considered indicative of urethral hypermobility, representing a recognised risk factor for stress urinary incontinence.\n\nUrethral descent will be quantified by measuring the position of the urethrovesical junction (UVJ) at rest and during maximal Valsalva. The vertical displacement of the UVJ will be measured in millimetres relative to a horizontal reference line passing through the inferior margin of the symphysis pubis.",{"measure":25,"description":26,"timeFrame":20},"Pelvic organ prolapse parameters assessed by ultrasound","Pelvic organ prolapse will be assessed using 2D transperineal ultrasound at rest and during maximal Valsalva manoeuvre. The primary points of interest will be the most distal point of the anterior vaginal wall and the cervix. Their positions will be measured in millimetres relative to a horizontal reference line passing through the inferior margin of the symphysis pubis. The change in position between rest and maximal Valsalva will be calculated.",{"measure":28,"description":29,"timeFrame":20},"Anal sphincter defects assessed by ultrasound","Anal sphincter integrity will be assessed using 4D transperineal ultrasound with tomographic ultrasound imaging (TUI). Nine tomographic slices, each separated by 2.5 mm, will be obtained according to the protocol described by Dietz. Defects of the external anal sphincter, internal anal sphincter, or both will be considered present only when the defect is visible in at least three consecutive slices and has a circumferential extent of at least 30°.",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NON_RANDOMIZED","SEQUENTIAL","PREVENTION",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38,41],{"label":39,"type":40,"description":30,"interventionNames":30},"Baseline cohort","NO_INTERVENTION",{"label":42,"type":43,"description":30,"interventionNames":44},"Postinterventional cohort","EXPERIMENTAL",[45],"Other: Obstetric training",[47],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"Obstetric training","The intervention consists of staff education (physicians and midwives) in the form of obstetric training focused on perineal protection, episiotomy techniques, and the management of birth-related perineal trauma. The patients themselves do not undergo any intervention.",[42],[52],{"name":53,"role":54,"phone":55,"phoneExt":30,"email":56},"Dominik Habes, MD","CONTACT","+420732545650","dominik.habes@seznam.cz",[58],{"facility":5,"status":59,"city":60,"state":30,"zip":30,"country":61,"countryCode":30,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Hradec Králové","Czechia",{"type":63,"coordinates":64},"Point",[65,66],15.83277,50.20923,{"lat":66,"lon":65},[69],{"name":53,"role":54,"phone":55,"phoneExt":30,"email":56},{"type":71,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100659498","improving-postpartum-quality-of-life-through-enhanced-perineal-care-training-100659498",false,"NCT07865065","Improving Postpartum Quality of Life Through Enhanced Perineal Care Training","Effect of Structured Perineal Care Training on Postpartum Quality of Life and Sonographic Maternal Injury Detection","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Provision of written informed consent\n* Primiparity\n* Singleton pregnancy\n* Gestational age ≥ 36 + 0 weeks at the time of delivery\n* Vaginal delivery, including spontaneous, forceps-assisted, or vacuum-assisted births\n* No history of anorectal disease and no prior anal or rectal surgery\n\nExclusion Criteria:\n\n* Multiparity\n* Premature delivery\n* Twin pregnancy\n* Any preexisting anorectal disease\n* Preexisting urinary and\u002For anal incontinence before pregnancy","FEMALE","18 Years",{"count":82,"type":83},380,"ESTIMATED","INTERVENTIONAL",[86],"NA","This prospective interventional before and after study evaluates whether structured obstetric training-covering perineal protection, improved episiotomy technique, systematic detection of obstetric anal sphincter injuries (OASI), and hands on OASI repair-can improve early postpartum quality of life and reduce peripartal pelvic floor trauma in primiparous women after term vaginal delivery.\n\nThe primary aim is to determine whether the intervention decreases the incidence of postpartum anal incontinence and stress urinary incontinence. Secondary objectives include assessing changes in ultrasound based markers of pelvic floor integrity, specifically levator ani avulsion, urethral mobility or descent, pelvic organ prolapse parameters, and anal sphincter defects.\n\nThe study population consists exclusively of primiparous women following their first term vaginal birth, minimizing confounding from prior obstetric history.\n\nBefore the training intervention, a baseline cohort was enrolled under standard obstetric practice. After all obstetric staff (physicians and midwives) completed the structured hands on training program, a post intervention cohort was enrolled, with care provided using the newly implemented techniques.\n\nAll participants undergo standardized assessment three months postpartum, including quality of life questionnaires focused on pelvic floor symptoms and transperineal ultrasound examination according to the method described by Dietz, evaluating levator ani integrity, urethral mobility, and pelvic organ support.",[89,90],"Postpartum Quality of Life","Peripartal Maternal Trauma",[92,93,94,95],"Postpartal QoL","Obstetric anal sphincter injury","prevention","obstetric training","2026-10-02",{"date":98,"type":99},"2026-10-08","ACTUAL",{"date":101,"type":99},"2025-07-01",{"date":103,"type":83},"2027-01",{"name":5,"class":6},1]