[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"perineal-infection\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:perineal-infection":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":37,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":5},"100659339","perineal-protection-device-for-reducing-perineal-trauma-during-vaginal-delivery-in-first-time-mothers-a-multicenter-randomized-controlled-trial-100659339",false,"NCT07862660","Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial","Risk Reduction of Perineal Trauma With a Perineal Protection Device, a Multicenter Randomized Controlled Trial - The PeriPROTECT Trial","PeriPROTECT","Inclusion Criteria:\n\n* Women with no prior vaginal birth (including one previous cesarean section). Singleton, live fetus in cephalic presentation. Gestational age ≥34 weeks. Age ≥ 18 years. Planned vaginal birth.\n\nExclusion Criteria:\n\n* Cesarean section before randomization. Water birth. Participation in another clinical trial with perineal tear as primary outcome.","FEMALE","18 Years",{"count":20,"type":21},4226,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine whether using a soft perineal protection device (BabySlide®) in addition to standard manual perineal support during vaginal delivery can reduce the risk of perineal trauma in first-time mothers. The main questions it aims to answer are:\n\nDoes the use of BabySlide® reduce the risk of obstetric anal sphincter injury (OASI)? Does the use of BabySlide® reduce the risk of second-, third-, or fourth-degree perineal tears and\u002For episiotomy?\n\nResearchers will compare women randomized to receive BabySlide® in addition to standard manual perineal support with women receiving standard manual perineal support alone to determine whether the device reduces perineal trauma during vaginal delivery.\n\nParticipants will:\n\nbe randomized during the late second stage of labour to either BabySlide® plus standard manual perineal support or standard manual perineal support alone; receive the allocated perineal protection method during vaginal delivery; have perineal outcomes assessed and documented after delivery; and complete follow-up assessments and questionnaires after delivery to evaluate recovery and pelvic floor symptoms.",[27,28,29,30,31,32,33,34,35,36],"Pelvic Floor Dysfunction","Perineal Laceration","Wound Dehiscence","Anal Incontinence","Sexual Dysfunction and the Mode of Deliveries","Perineal Injury","Perineal Infection","Perineal Pain","Pelvic Organ Prolapse (POP)","Levator Ani Muscle Injury",[38,39,40,41,42,43,44,45,46],"perineal protection device","obstetric anal sphincter injury","perineal laceration","episiotomy","perineal tear","BabySlide","vaginal delivery","Childbirth","Primiparous","NOT_YET_RECRUITING","2026-10-01",{"date":50,"type":51},"2026-10-07","ACTUAL",{"date":53,"type":21},"2026-10-05",{"date":55,"type":21},"2030-12",{"name":57,"class":58},"Region Skane","OTHER"]