[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581489":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":67,"collaborators":27,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":27,"eligibilityCriteria":74,"healthyVolunteers":71,"sex":75,"minAge":76,"maxAge":27,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Stony Brook University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Foley Balloon and misoprostol","EXPERIMENTAL","Patients in the Foley Balloon arm will have a Foley balloon catheter placed trans-cervically and also receive misoprostol per protocol",[13,14],"Device: Foley Balloon Catheter","Drug: Misoprostol",{"label":16,"type":17,"description":18,"interventionNames":19},"Laminaria","ACTIVE_COMPARATOR","Patients in the Laminaria arm will have a Laminaria placed in the cervix and it will be left in situ per protocol",[20],"Device: Laminaria",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DEVICE","Foley Balloon Catheter","18 French Foley Balloon placed trans-cervically and inflated with 30-60ml of Normal Saline.",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","Misoprostol","400 mcg of buccal misoprostol sublingual",[9],{"type":23,"name":16,"description":34,"armGroupLabels":35,"otherNames":27},"Laminaria will be placed in the cervix according to the following standard formula: Estimated gestational age -10 = number of 5mm laminaria.",[16],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Sierra Washington, MD MSc","CONTACT","+258 84 147 7208","sierra.washington@stonybrookmedicine.edu",[43],{"facility":44,"status":45,"city":46,"state":27,"zip":27,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Hospital Central De Maputo","RECRUITING","Maputo","Mozambique","MZ",{"type":50,"coordinates":51},"Point",[52,53],32.58322,-25.96553,{"lat":53,"lon":52},[56,60,64],{"name":57,"role":39,"phone":58,"phoneExt":27,"email":59},"Sibone Mocumbi, MD PhD","+258 843250540","sibone@yahoo.com",{"name":61,"role":39,"phone":62,"phoneExt":27,"email":63},"Sierra Washington, MD Msc","+258 841477208","sierra.washington@stonybrook.edu",{"name":65,"role":66,"phone":27,"phoneExt":27,"email":27},"Sierra Washington","PRINCIPAL_INVESTIGATOR",{"type":66,"investigatorFullName":65,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"MD, Clinical Associate Professor","100581489","foley-balloon-for-cervical-preparation-before-dilation-and-evacuation-100581489",false,"NCT06850974","Foley Balloon for Cervical Preparation Before Dilation and Evacuation","Inclusion Criteria:\n\n* Women 18 years and older presenting to Hospital Central de Maputo requiring abortion for any legal indication between 16-21 weeks gestation.\n* Portuguese speaking\n\nExclusion Criteria:\n\n* Less than age 18\n* Incarcerated\n* Chorioamnionitis\n* Active heavy bleeding\n* A known bleeding diathesis\n* Hemodynamic instability\n* \\> 2 cm dilation\n* History of cervical cerclage\n* Allergy to any study medications\n* Eclampsia\n* Glasgow Coma Score Less than 15","FEMALE","18 Years",{"count":78,"type":79},102,"ESTIMATED","INTERVENTIONAL",[82],"NA","To evaluate the Foley Balloon technique for cervical preparation before second trimester surgical abortion between 16 and 21 weeks estimated gestational age in combination with misoprostol to prepare the cervix before dilation and evacuation (D\\&E) instead of osmotic dilators (Laminaria).\n\nSpecific Aim One: Assess definitively whether using a Foley Balloon and Misoprostol is non-inferior to osmotic dilators for cervical preparation before D\\&E.\n\nSpecific Aim Two: Evaluate patient satisfaction with the two methods of second trimester abortion.\n\nSpecific Aim Three: Evaluate provider satisfaction with the two methods of second trimester abortion.",[85,86],"Abortion, Second Trimester","Abortion, Medical",[88,89,90,91,92,93],"second","trimester","abortion","surgical","balloon","Foley","2026-04-26",{"date":96,"type":97},"2026-04-30","ACTUAL",{"date":99,"type":97},"2025-02-10",{"date":101,"type":79},"2027-03",{"name":5,"class":6},1]