[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"levator-ani-muscle-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:levator-ani-muscle-injury":36},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,60],{"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":59},"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",1,{"id":61,"slug":62,"hasResults":11,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":79,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":92,"leadSponsor":94,"locationsCount":59},"100654332","pelvic-floor-ultrasound-before-induction-of-labour-and-labour-outcome-100654332","NCT07797387","Pelvic Floor Ultrasound Before Induction of Labour and Labour Outcome","Antepartum Three-Dimensional Transperineal Ultrasound Assessment of the Levator Hiatus and Labour Outcome in Women Undergoing Induction of Labour: A Prospective Observational Cohort Study","LEVATOR-IOL","Inclusion Criteria -\n\n* Age 18 years or older\n* Singleton pregnancy with cephalic presentation\n* Gestational age of 36 weeks 0 days or more, dated by first-trimester crown-rump length\n* Scheduled for induction of labour with a planned attempt at vaginal delivery, for any clinical indication\n* Ultrasound assessment feasible before administration of the first cervical ripening agent\n* Written informed consent Exclusion Criteria - Multiple pregnancy or non-cephalic presentation\n* Known fetal structural or chromosomal anomaly\n* Previous caesarean section or previous uterine surgery\n* Planned caesarean section or a contraindication to vaginal delivery arising before the ultrasound assessment\n* Connective tissue disease, neuropathy or neuromuscular disease affecting the pelvic floor\n* Previous pelvic floor or anti-incontinence surgery - Active labour, or ruptured membranes with regular contractions, at the time of the scheduled assessment\n* Inability to perform an adequate Valsalva manoeuvre or pelvic floor contraction after standardised instruction\n* Inability to provide informed consent or to understand the study questionnaires",true,{"count":70,"type":21},140,"OBSERVATIONAL","Pregnancy and vaginal birth are the main causes of pelvic floor disorders such as urinary incontinence and pelvic organ prolapse. The levator hiatus - the opening in the pelvic floor muscles through which the baby passes - can be measured on three-dimensional transperineal ultrasound at rest, during pelvic floor contraction and during a Valsalva manoeuvre. Its size and its ability to stretch have been related to how long labour lasts and to how the baby is eventually born, but the evidence comes mostly from women in spontaneous labour, in whom the exact time labour began cannot be established.\n\nWomen having their labour induced offer a better model, because the time each stage of labour begins is documented. Recently, automated software has made the measurement of the levator hiatus fast and reproducible, which makes it realistic to use in everyday practice.\n\nThis prospective observational study will enrol 140 women with a singleton pregnancy at 36 weeks or more who are scheduled for induction of labour. Before induction begins, each woman will have a transperineal ultrasound scan of the pelvic floor at rest, on maximum contraction and on maximum Valsalva. The scan does not involve any vaginal probe, radiation or injection, and takes about 15 minutes. The times of each phase of labour, the way the baby is born and the condition of the perineum after birth will be recorded prospectively from the clinical record. The scan will be repeated before hospital discharge and about one month after birth, together with validated pelvic floor symptom questionnaires.\n\nThe main question is whether the area of the levator hiatus measured on Valsalva before induction is related to the duration of the active, pushing phase of the second stage of labour. The study will also examine the duration of the first stage, the mode of delivery, and how the pelvic floor changes in the first month after an induced birth.\n\nStudy procedures do not influence clinical care in any way: induction and labour are managed according to standard departmental protocols, and the research ultrasound results are not disclosed to the clinical team.",[74,75,76,77,78,36],"Labor","Pelvic Floor Disorder","Labor Stage, Second","Induced Labor","Pelvic Floor",[80,81,82,83,84,85,86,87],"transperineal ultrasound","levator hiatus","pelvic floor","induction of labor","second stage of labor","3d Ultrasound","levator ani","automated segmentation","2026-09-02",{"date":90,"type":51},"2026-09-03",{"date":48,"type":21},{"date":93,"type":21},"2028-11-01",{"name":95,"class":58},"University of Roma La Sapienza"]