[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555025":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":44,"responsibleParty":64,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":89,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Insel Gruppe AG, University Hospital Bern","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Double balloon device","ACTIVE_COMPARATOR","In this group of patients, the labour will be induced using the Cook double balloon device",[13],"Device: Double ballon device, Cook",{"label":15,"type":10,"description":16,"interventionNames":17},"Hygroscopic cervix dilators","In this group of patients, the labour will be induced using the hygroscopic cervix dilators Dilapan-S",[18],"Device: Hygroscopic cervix dilators, Dilapan-S",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Double ballon device, Cook","Cook double balloon will be introduced transcervically. The double balloon will be inflated with sterile 0-9% saline solution (maximum 80 ml in each balloon of the double device), then the catheter will be fixed with a tape at the women's thigh without traction. The catheter will remain in place until spontaneously expelled or start of active labour.\n\nIf neither happens, the device will be removed after 12-24 hours and oxytocin will be administered and amniotomy as soon as feasible. If the cervix remains unfavorable after two cycles of 6 hours of oxytocin infusion, the induction will be classified as unsuccessful and C-section will be performed.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Hygroscopic cervix dilators, Dilapan-S","A maximum number of 5 hygroscopic cervical dilator rods will be inserted transcervically, after humidification with sterile 0.9% saline solution. They will be fixed in this position by inserting a humidified compress into the vagina. They will remain in place until spontaneously expelled or until start of active labour.\n\nIn neither happens, the devices will be removed after 12-24 hours and oxytocin will be administered and amniotomy as soon as feasible. If the cervix remains unfavorable after two cycles of 6 hours of oxytocin infusion, the induction will be classified as unsuccessful and C-section will be performed.",[15],[31],{"name":32,"affiliation":33,"role":34},"Daniel Surbek, Prof. Dr.","Co-Chairman, Departament of Obstetrics an Gynäkology, Head of Obstetrics and feto-maternal Medicine, University Hospital Bern","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Anda P Radan, PD Dr. med.","CONTACT","+41\u002F0316321010","Anda-Petronela.Radan@insel.ch",{"name":42,"role":38,"phone":39,"phoneExt":25,"email":43},"Mihaela M Fluri, Dr. med.univ.","mihaela-madalina.fluri@insel.ch",[45],{"facility":46,"status":47,"city":48,"state":25,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"University Hospital of Obstetrics and Gynäkologie, Inselspital","RECRUITING","Bern","3010","Switzerland","CH",{"type":53,"coordinates":54},"Point",[55,56],7.44744,46.94809,{"lat":56,"lon":55},[59,61,63],{"name":37,"role":38,"phone":60,"phoneExt":25,"email":40},"0041\u002F 0316321010",{"name":62,"role":38,"phone":60,"phoneExt":25,"email":43},"Mihaela M Fluri, Dr. med. univ.",{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":65,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100555025","comparison-between-two-medical-devices-for-labor-induction-after-previous-c-section-100555025",false,"NCT06506721","Comparison Between Two Medical Devices for Labor Induction After Previous C-section","Balloon Catheter vs. Hygroscopic Cervical Dilator for Labour Induction After Previous Caesarean Section: an Open Prospective Randomized Controlled Trial","DiBal","Inclusion Criteria:\n\n* All women \\>= 18years old with a previous CS and an indication of labour induction, between 24-42 weeks of pregnancy.\n* Modified Bishop-Score \\\u003C 6\n* Informed consent\n\nExclusion criteria:\n\n* More than 1 CS\n* Premature rupture of membranes\n* Vaginal infection\n* Intrauterine fetal demise\n* Twin pregnancy\n* Contraindication against labour induction or vaginal delivery\n* Vaginal bleeding\n* Simultaneous external administration of prostaglandins planned\n* Placenta praevia, vasa praevia or placenta accreta spectrum\n* Transverse fetal orientation\n* Prolapsed umbilical cord\n* Prior hysterotomy, classic uterine incision, myomectomy or any other full thickness uterine incision (except C-section)\n* Pelvic structural anomaly\n* Active genital herpes infection\n* Invasive cervical cancer\n* Abnormal fetal heart rate pattern\n* Breech presentation\n* Maternal heart disease\n* Polyhydramnios\n* Presentic part above the pelvic inlet\n* Severe maternal hypertension",true,"FEMALE","18 Years","60 Years",{"count":79,"type":80},137,"ESTIMATED","INTERVENTIONAL",[83],"NA","The objective of the study ist to compare the Dilapan-S and the Cook Ballon device for the mechanical induction of labour in women with a previous C-section. There is currently lack of data regarding this comparison of the two methods for mechanical labour induction in this patient collective. Any method used for labour induction is therefore off-label. The primary outcome is the time between placement of the device and delivery. Ad secondary outcomes are among others the cesarean delivery rate and patient satisfaction with the induction method.",[86,87,88],"Delivery, Obstetric","Cesarean Section","Obstetric Delivery",[90],"Trial of Labour","2025-01-10",{"date":93,"type":94},"2025-01-14","ACTUAL",{"date":96,"type":94},"2023-12-29",{"date":98,"type":80},"2026-12-28",{"name":5,"class":6},1]