[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538845":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":30,"responsibleParty":46,"collaborators":18,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":18,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":18,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Azienda Sanitaria Universitaria Friuli Centrale","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"perineal massage","EXPERIMENTAL","participants randomized to this arm are asked to perform themselves the perineal massage once daily from 34 gestational weeks until delivery.",[13],"Behavioral: perineal massage",{"label":15,"type":16,"description":17,"interventionNames":18},"standard care","NO_INTERVENTION","participants randomized to this arm are asked to care for their pelvic floor according to the standard practice, which includes healthy diet, weight gain control, physical activity and voiding training therapy.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","women affected by LAM co-activation allocated to the intervention \"perineal massage\" are asked to perform the perineal massage once daily from 34 gestational weeks until delivery. Women are trained to correctly perform the perineal massage at 30 gestaitonal weeks.",[9],[25],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Serena Xodo, M.D.","CONTACT","0432-559699","serena.xodo@gmail.com",[31],{"facility":32,"status":33,"city":34,"state":18,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Serena Xodo","RECRUITING","Udine","33100","Italy","IT",{"type":39,"coordinates":40},"Point",[41,42],13.23715,46.0693,{"lat":42,"lon":41},[45],{"name":32,"role":27,"phone":28,"phoneExt":18,"email":29},{"type":47,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100538845","perineal-massage-in-pregnancy-to-reduce-the-levator-ani-coactivation-100538845",false,"NCT06296134","Perineal Massage in Pregnancy to Reduce the Levator Ani Coactivation","Does Perineal Massage in Pregnancy Reduce the Levator Ani Muscle Co-activation?","CO-LAM23","Inclusion Criteria: pregnant women with the following characteristics:\n\n* nulliparous\n* single pregnancy\n* cephalic presentation of the fetus\n* Italian language fluency\n\nExclusion Criteria:\n\n* multiparous\n* age \\\u003C 18 y, age \\> 40 y\n* previous urinary or fecal incontinence\n* contraindications to vaginal delivery (such as placenta previa, vasa previa, etc)\n* twin pregnancy\n* language barrier\n* BMI at or \\> 30",true,"FEMALE","18 Years","40 Years",{"count":61,"type":62},58,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this clinical trial is to test the efficacy of the perineal massage in reducing the levator ani muscle (LAM) co-activation. This phenomenon is characterized by the LAM contraction rather than its relaxation during the Valsalva maneuver and it is associated with adverse obstetric outcome. Participants who co-activate will be enrolled and randomized in 2 groups: group A, where women themselves perform the perineal massage during the third trimester of pregnancy and group B, where women undergo the standard care. Researchers will compare these groups to see if the perineal massage is able to reduce LAM co-activation.",[68,69],"Pelvic Floor Disorders","Levator Ani Syndrome","2024-08-01",{"date":72,"type":73},"2024-08-02","ACTUAL",{"date":70,"type":73},{"date":76,"type":62},"2025-12-31",{"name":5,"class":6},1]