[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497649":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":33,"locations":41,"responsibleParty":144,"collaborators":18,"id":147,"slug":148,"hasResults":149,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":155,"sex":156,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":18,"studyType":162,"phases":163,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":44,"whyStopped":18,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Outpatient cervical ripening with Foley","EXPERIMENTAL","Cervical ripening will begin with a Foley balloon in the outpatient setting",[13],"Device: Outpatient Foley catheter",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of care Inpatient cervical ripening","NO_INTERVENTION","Cervical ripening will begin in the inpatient setting with Foley ballooon or other cervical ripening agent",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Outpatient Foley catheter","Outpatient Foley catheter placement for induction of labor",[9],[26,30],{"name":27,"affiliation":28,"role":29},"Lisa Levine, MD, MSCE","University of Pennsylvaina","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Alison Cahill, MD, MSCI","University of Texas at Austin",[34,38],{"name":27,"role":35,"phone":36,"phoneExt":18,"email":37},"CONTACT","215-283-7373","lisa.levine@pennmedicine.upenn.edu",{"name":39,"role":35,"phone":36,"phoneExt":18,"email":40},"Meaghan McCabe, MPH","meaghan.mccabe@pennmedicine.upenn.edu",[42,68,84,97,112,129],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Christiana Care Health Services, Inc.","RECRUITING","Newark","Delaware","19718","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-75.74966,39.68372,{"lat":54,"lon":53},[57,60,63,65],{"name":58,"role":35,"phone":18,"phoneExt":18,"email":59},"Carrie Kitto","ckitto@christianacare.org",{"name":61,"role":35,"phone":18,"phoneExt":18,"email":62},"Amy Staples","amy.staples@christianacare.org",{"name":64,"role":29,"phone":18,"phoneExt":18,"email":18},"Anthony Sciscione, MD",{"name":66,"role":67,"phone":18,"phoneExt":18,"email":18},"Suneet Chauhaun, MD","SUB_INVESTIGATOR",{"facility":69,"status":44,"city":70,"state":71,"zip":72,"country":48,"countryCode":49,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"Princeton Medical Center","Plainsboro","New 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MSCI",{"facility":113,"status":44,"city":114,"state":115,"zip":116,"country":48,"countryCode":49,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Intermountain Health Utah Valley Hospital","Provo","Utah","84604",{"type":51,"coordinates":118},[119,120],-111.65853,40.23384,{"lat":120,"lon":119},[123,127],{"name":124,"role":35,"phone":125,"phoneExt":18,"email":126},"Stacey Breeze","801-507-7433","stacey.breeze@imail.org",{"name":128,"role":29,"phone":18,"phoneExt":18,"email":18},"Jessica Page, MD",{"facility":130,"status":44,"city":131,"state":115,"zip":132,"country":48,"countryCode":49,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"University of Utah","Salt Lake City","84112",{"type":51,"coordinates":134},[135,136],-111.89105,40.76078,{"lat":136,"lon":135},[139,142],{"name":140,"role":35,"phone":18,"phoneExt":18,"email":141},"Stephen Forsyth","stephen.forsyth@hsc.utah.edu",{"name":143,"role":29,"phone":18,"phoneExt":18,"email":18},"Robert M Silver, MD",{"type":29,"investigatorFullName":145,"investigatorTitle":146,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Lisa Levine","Associate Professor, Division of Maternal Fetal Medicine","100497649","cervical-ripening-as-an-outpatient-method-using-the-foley-comfort-100497649",false,"NCT05759988","Cervical Ripening as an Outpatient Method Using the Foley (COMFORT)","Cervical Ripening as an Outpatient Method Using the Foley: a Randomized Trial","COMFORT","Inclusion Criteria\n\n* Eligible for induction of labor\n* Live singleton gestation ≥37 weeks and \\\u003C42 weeks\n* Nulliparous, ≥18 years of age with no previous deliveries \\>20 weeks\n* Cephalic presentation\n* Intact membranes\n* Bishop score ≤8 and cervical dilation \\\u003C3 cm\n* English or Spanish speaking (Able to read\u002Funderstand consent and instructions)\n* Have reliable transportation to get back to the hospital and have a self-reported safe residence to go home to with the Foley catheter\n\nExclusion Criteria\n\n* Known oligohydramnios (DVP \\\u003C2cm)\n* Known moderate-severe polyhydramnios (AFI ≥30 at time of delivery)\n* Concern regarding fetal status during antenatal testing: At provider discretion, but includes fetal decelerations, biophysical profile ≤6\u002F10\n* Vaginal bleeding or concern for\u002Fknown abruption prior to Foley placement\n* Chorioamnionitis\n* Any fetal growth restriction\n* Preeclampsia with severe features\n* Severe chronic hypertension\n* Type 1 diabetes or poorly controlled pre-gestational diabetes\n* Sickle cell disease\n* Major fetal anomaly\n* Women on therapeutic anticoagulation\n* Decreased fetal movement\n* HIV Positive (rationale: HIV positive patients require an IV medication at the start of labor induction which cannot be given as an outpatient. There is universal testing of HIV in the 3rd trimester to verify this exclusion criteria)\n* Maternal cardiac disease requiring telemetry monitoring throughout induction\u002Flabor course",true,"FEMALE","18 Years","60 Years",{"count":160,"type":161},2300,"ESTIMATED","INTERVENTIONAL",[164],"NA","A multicenter pragmatic randomized trial of nulliparous women undergoing a term (≥37 weeks) induction of labor wherein the provider intends to use a Foley catheter for cervical ripening. The investigators will be comparing outpatient cervical ripening with a Foley catheter to routine inpatient cervical ripening (Foley +\u002F- other method). With this trial, the investigators aim to test our central hypothesis that outpatient Foley will decrease the primary Cesarean Delivery (CD) rate and risk of maternal\u002Fneonatal morbidity compared with inpatient cervical ripening.",[167],"Induction of Labor Affected Fetus \u002F Newborn",[169,170],"Foley balloon catheter","Outpatient cervical ripening","2026-01-29",{"date":173,"type":174},"2026-02-02","ACTUAL",{"date":176,"type":174},"2023-04-13",{"date":178,"type":161},"2027-06-30",{"name":5,"class":6},6]