[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646556":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":26,"overallStatus":33,"whyStopped":26,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Rambam Health Care Campus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"3 hours balloon group","EXPERIMENTAL","Double-balloon cervical ripening catheter inserted and left in place for 3 hours before removal",[13],"Device: Cook Cervical Ripening Balloon 3 hours",{"label":15,"type":16,"description":17,"interventionNames":18},"12 hours balloon group","ACTIVE_COMPARATOR","Double-balloon cervical ripening catheter inserted and left in place for 12 hours before removal",[19],"Device: Cook Cervical Ripening Balloon 12 hours",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Cook Cervical Ripening Balloon 3 hours","Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 3 hours.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cook Cervical Ripening Balloon 12 hours","Use of a transcervical balloon catheter for pre-induction cervical ripening. The catheter is inserted through the cervix, the balloon(s) inflated with sterile saline. The device remains in place for 12 hours.",[15],[32],{"facility":5,"status":33,"city":34,"state":26,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Haifa","31906","Israel","IL",{"type":39,"coordinates":40},"Point",[41,42],34.99928,32.81303,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"Bar Rosh, MD","CONTACT","+972- 4-777-1779","b_rosh@rmc.gov.il",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Bar Rosh MD","Resident","100646556","cervical-ripening-balloon-3-hours-vs-12-hours-placement-100646556",false,"NCT07689357","Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement","Comparison of Labor Induction With Cervical Ripening Balloon, 3 Hours vs 12 Hours Placement: a Randomized Controlled Trail","Inclusion Criteria:\n\n* Nulliparous or multiparous pregnant women.\n* Gestational age between 37 0\u002F7 and 41 6\u002F7 weeks of gestation.\n* Maternal age between 18 and 45 years.\n* Participant has provided signed informed consent.\n\nExclusion Criteria:\n\n* Presence of any contraindications for vaginal delivery.\n* Multifetal gestation.\n* Rupture of membranes prior to balloon insertion.\n* Favorable cervix, defined as a Bishop score greater than 6.\n* Cervical dilation greater than 2 cm.\n* Previous cesarean delivery or any other prior major uterine surgery.","FEMALE","18 Years","45 Years",{"count":65,"type":66},164,"ESTIMATED","INTERVENTIONAL",[69],"NA","The goal of this clinical trial is to learn if a shorter duration of cervical ripening balloon (CRB) placement can reduce the time to delivery in pregnant women undergoing induction of labor.\n\nThe main questions it aims to answer are:\n\nDoes placing the cervical ripening balloon for 3 hours or less result in a shorter interval from insertion to delivery compared to the standard 12-hour placement?\n\nDoes a shorter 3-hour balloon placement lead to better pregnancy outcomes, fewer complications, and lower maternal discomfort?\n\nResearchers will compare a group of participants who have the balloon removed after 3 hours to a control group who have the balloon removed after 12 hours to see if the shorter duration decreases the overall time to delivery.\n\nParticipants will:\n\nSign an informed consent and be randomized into one of the two groups (3 hours vs. 12 hours).\n\nUndergo the standard procedure of a double-lumen Cook cervical ripening balloon insertion.\n\nHave the balloon removed after approximately 3 hours or 12 hours depending on their assigned group.\n\nProceed with amniotomy or Pitocin use at the discretion of the labor and delivery physician.\n\nComplete a Birth Satisfaction Scale questionnaire and have their maternal and neonatal health outcomes tracked from the hospital's database.",[72,73],"Labor Induction","Cervical Ripening and Induction of Labor","2026-07-07",{"date":76,"type":77},"2026-07-08","ACTUAL",{"date":79,"type":77},"2026-05-27",{"date":81,"type":66},"2028-11-01",{"name":5,"class":6},1]