[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525497":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":38,"locations":44,"responsibleParty":72,"collaborators":74,"id":104,"slug":105,"hasResults":106,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":106,"sex":111,"minAge":112,"maxAge":29,"enrollmentInfo":113,"targetDuration":29,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":46,"whyStopped":29,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Laparoscopic cerclage",[13],"Procedure: Laparoscopic cerclage",{"label":15,"type":10,"description":16,"interventionNames":17},"Control","Vaginal cerclage",[18],"Procedure: Vaginal cerclage",[20,26],{"type":21,"name":11,"description":22,"armGroupLabels":23,"otherNames":24},"PROCEDURE","Classic or robot-assisted laparoscopic cerclage in non-pregnant or early pregnant women.",[9],[25],"Abdominal cerclage",{"type":21,"name":16,"description":27,"armGroupLabels":28,"otherNames":29},"Transvaginal cerclage in pregnant women.",[15],null,[31,35],{"name":32,"affiliation":33,"role":34},"Niels Uldbjerg, DMSc","Aarhus University Hospital","STUDY_DIRECTOR",{"name":36,"affiliation":33,"role":37},"Julie Glavind, MD, PhD","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Lea K Hansen, MD","CONTACT","+45 51910993","lea.hansen@clin.au.dk",[45,61],{"facility":33,"status":46,"city":47,"state":29,"zip":29,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"RECRUITING","Aarhus N","Denmark","DK",{"type":51,"coordinates":52},"Point",[53,54],10.17317,56.20367,{"lat":54,"lon":53},[57,60],{"name":58,"role":41,"phone":59,"phoneExt":29,"email":43},"LEA HANSEN, MD","51910993",{"name":58,"role":37,"phone":29,"phoneExt":29,"email":29},{"facility":62,"status":46,"city":63,"state":29,"zip":29,"country":48,"countryCode":49,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Rigshospitalet","Copenhagen",{"type":51,"coordinates":65},[66,67],12.56553,55.67594,{"lat":67,"lon":66},[70],{"name":71,"role":41,"phone":29,"phoneExt":29,"email":29},"Lone Storgaard, PhD",{"type":73,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[75,77,79,81,83,85,88,90,92,94,96,97,99,102],{"name":76,"class":6},"Rigshospitalet, Denmark",{"name":78,"class":6},"Viborg Regional Hospital",{"name":80,"class":6},"Gødstrup Hospital",{"name":82,"class":6},"Aalborg University Hospital",{"name":84,"class":6},"Randers Regional Hospital",{"name":86,"class":87},"Regionshospital Nordjylland","OTHER_GOV",{"name":89,"class":6},"Odense University Hospital",{"name":91,"class":6},"Hvidovre University Hospital",{"name":93,"class":6},"Oslo University Hospital",{"name":95,"class":6},"Herlev Hospital",{"name":33,"class":6},{"name":98,"class":6},"Horsens Hospital",{"name":100,"class":101},"Bornholm Hospital, Denmark","UNKNOWN",{"name":103,"class":6},"Lund University Hospital","100525497","nordic-randomized-trial-on-laparoscopic-versus-vaginal-cerclage-100525497",false,"NCT06122506","Nordic Randomized Trial on Laparoscopic Versus Vaginal Cerclage","NORACT","Inclusion Criteria:\n\n* Women in whom the clinician has equipoise as to whether an elective vaginal or abdominal cerclage will be the best intervention to prevent preterm birth.\n* Not yet pregnant or \\\u003C10 weeks' pregnant.\n\nExclusion Criteria:\n\n* Any circumstance under which the clinician is not willing to randomize is an exclusion criterion.\n* Any condition or circumstance under which laparoscopic or vaginal cerclage surgery is contraindicated (i.e. on-going pregnancy of more than 10+0 gestational weeks).\n* Language difficulties.","FEMALE","18 Years",{"count":114,"type":115},188,"ESTIMATED","INTERVENTIONAL",[118],"NA","Every year 15 million babies are born prematurely, which can lead to death or life-long disabilities. It is often caused by a dysfunction of the uterine cervix, which constitutes the narrow channel between the vagina and womb. During pregnancy, this channel must remain closed until the beginning of term labor. A weak cervix may not withstand the weight of the fetus, the amniotic fluid and the placenta and the cervical canal will open and cause late miscarriage or preterm delivery. To prevent this, a band (cerclage) can be applied around the cervix either vaginally or laparoscopically prior to a new pregnancy.\n\nTo evaluate which treatment is best for most women, we will randomize (allocate by chance) women at risk for preterm birth, to either vaginal cerclage or laparoscopic cerclage in the Nordic countries and England",[121,122],"Preterm Birth","Cervical Insufficiency",[124],"cerclage","2024-12-05",{"date":127,"type":128},"2024-12-10","ACTUAL",{"date":130,"type":128},"2024-01-31",{"date":132,"type":115},"2028-03",{"name":5,"class":6},2]