[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609148":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":31,"studyPopulation":32,"armGroups":33,"interventions":27,"overallOfficials":37,"centralContacts":41,"locations":52,"responsibleParty":73,"collaborators":76,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":27,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":87,"minAge":88,"maxAge":27,"enrollmentInfo":89,"targetDuration":27,"studyType":92,"phases":27,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Université de Sherbrooke","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":27},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of participants with complete and partial unilateral or bilateral avulsion of the levator ani muscles in the post-partum period","Diagnostic established with standard levator-urethra gap measures assessed with a transperineal 4D ultrasound","In the post-partum period, up to 1 year post-partum",{"measure":14,"description":15,"timeFrame":16},"Crowning time of the fetal head","The time between the crowning of the fetal head and birth is systematically recorded during labor at the study center for all deliveries. Only participants who meet the inclusion criteria are considered for the study.","The data was obtained from the medical records of each participant during labor.",[18,21,24],{"measure":19,"description":20,"timeFrame":16},"Rate and type of perineal tears","Grade of perineal tear collected in the medical file",{"measure":22,"description":23,"timeFrame":12},"Incidence and severity of urogynecological symptoms","Validated questionnaires on urogynecological symptoms: PFDI-46 and ICIQ-IU-SF\n\nPFDI-46 (Pelvic Floor Distress Inventory - 46 Items) Full title: Pelvic Floor Distress Inventory\n\nStructure \\& Scoring: It comprises three subscales:\n\n1. UDI (Urinary Distress Inventory): range 0-300\n2. POPDI (Pelvic Organ Prolapse Distress Inventory): range 0-300\n3. CRADI (Colorectal-Anal Distress Inventory): range 0-400 Interpretation: Higher scores indicate worse symptom distress-i.e., a higher burden of pelvic floor symptom\n\nICIQ-UI-SF (International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form) Full title: International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form Scoring: Total score: 0-21 (sum of items 3, 4, and 5; items 1, 2 are demographic, one item is unscored) Interpretation: A higher score indicates greater severity of urinary incontinence and a greater negative impact on quality of life",{"measure":25,"description":26,"timeFrame":16},"Use of episiotomy","Type and use of episiotomy collected in the medical file",null,{"allocation":27,"interventionModel":27,"interventionModelDescription":27,"primaryPurpose":27,"observationalModel":29,"timePerspective":30,"maskingInfo":27},"COHORT","PROSPECTIVE","This is a prospective cohort study evaluating the impact of the crowning time of the fetal head in the second stage of labor on the incidence of levator ani muscle avulsion. Levator ani muscle is hypothesized to avulse during the distension of the pelvic floor muscles, as during a forceps use, and most probably during the crowning of the fetal head. In the study center, the crowning of the fetal head is systematically calculated during labor by nurses and doctors. To eliminate some potential confounding factors, only primiparous women with spontaneous vaginal delivery of a vertex position baby will be recruited in the post-partum period. In order to evaluate the presence of levator ani muscle avulsion, they will be assessed with a 4D transperineal ultrasound by using a standard diagnosis protocol. The delivery hospital file will then be examined to collect potential confounding variables. Prior to data collection, all study participants will give their written informed consent. This study will add more literature to the prevention of the levator ani muscle avulsion and its long-term complications.","The target population will recruit primiparous postpartum women who meet the inclusion criteria and gave birth at CHUS Fleurimont during the recruitment period.",[34],{"label":35,"type":27,"description":36,"interventionNames":27},"Primiparous women with singleton vertex position having a spontaneous vaginal birth","This cohort study follows primiparous women having had an unassisted by forceps or vacuum labor in post-partum with a 4D ultrasound of the perineum.",[38],{"name":39,"affiliation":5,"role":40},"Mélanie Morin, PT","STUDY_DIRECTOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Megan Boutilier, resident in OBGYN, Medical Degree","CONTACT","819-346-1110","72391","megan.boutilier@usherbrooke.ca",{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},"Marie-Élisabeth Bouchard, MD, Urogynecologist","72574","marie-elisabeth.bouchard@usherbrooke.ca",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"CHUS Fleurimont","RECRUITING","Sherbrooke","Quebec","J1H 5H3","Canada","CA",{"type":62,"coordinates":63},"Point",[64,65],-71.89908,45.40008,{"lat":65,"lon":64},[68,69,70],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},{"name":49,"role":44,"phone":45,"phoneExt":50,"email":51},{"name":71,"role":72,"phone":27,"phoneExt":27,"email":27},"Mélanie Morin, PT, PT","PRINCIPAL_INVESTIGATOR",{"type":72,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Mélanie Morin","Clinical Professor",[77],{"name":78,"class":6},"Centre de recherche du Centre hospitalier universitaire de Sherbrooke","100609148","the-effect-of-crowning-time-on-levator-ani-muscle-avulsion-100609148",false,"NCT07210788","The Effect of Crowning Time on Levator Ani Muscle Avulsion","Evaluation of Crowning Time on the Incidence of Levator Ani Muscle Avulsion","Inclusion Criteria:\n\nPrimiparous women GxT1 At term: ≥ 37+0 weeks of gestation (included) Spontaneous vaginal delivery (SVD) Cephalic presentation History of miscarriage before 20 weeks or with a fetal weight \\\u003C 350g\n\nExclusion Criteria:\n\nContraindications to vaginal delivery Assisted vaginal delivery Age under 18 years Shoulder dystocia Extensive pelvic reconstructive surgery (e.g., bladder exstrophy repair) Term intrauterine fetal demise Twin or multifetal pregnancy",true,"FEMALE","18 Years",{"count":90,"type":91},92,"ESTIMATED","OBSERVATIONAL","Levator ani muscle is one of the main components of perineal muscles and plays a crucial role in urinary continence and pelvic organ support. An avulsion, detachment from its insertion, of this muscle can occur during vaginal birth. It is well known that this major injury can cause many symptoms such as urinary incontinence and pelvic organ prolapses. Some risk factors of this important injury have been identified in the literature, such as the use of forceps. However, to date, no study has evaluated the impact of the crowning of the fetal head during labor on perineal muscles, specifically the levator ani muscle avulsion. Hence, the objectives of this study are to evaluate the association i) the time of the crowning of the fetal head during labor and levator ani muscle avulsion, ii) the time of the crowning of the fetal head and urogynecological symptoms, and iii) use of episiotomy and levator ani muscle avulsion. Postpartum primiparous women will undergo a 4D transperineal ultrasound to evaluate their pelvic muscles and complete questionnaires assessing urogynecological symptoms.",[95,96,97,98],"Time of the Crowning of the Fetal Head","Levator Ani Avulsion","Labor Delivery","Postpartum",[100,101,102,103,104,105,106,107],"levator ani","levator ani avulsion","crowning time","crowning time of the fetal head","primiparous","singleton foetus","vertex position","postpartum","2025-09-29",{"date":110,"type":111},"2025-10-07","ACTUAL",{"date":113,"type":111},"2024-04-23",{"date":115,"type":91},"2027-02",{"name":5,"class":6},1]