[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577496":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":70,"collaborators":43,"id":72,"slug":43,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":43,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":43,"enrollmentInfo":81,"targetDuration":43,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":92,"overallStatus":51,"whyStopped":43,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Boston Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcervical single-balloon catheter group","EXPERIMENTAL","Participants randomized to this arm will have cervical dilation done using a transcervical single-balloon catheter.",[13],"Device: Transcervical single-balloon catheter",{"label":15,"type":16,"description":17,"interventionNames":18},"Osmotic dilators group","ACTIVE_COMPARATOR","Participants randomized to this arm will have cervical dilation done using osmotic dilators.",[19],"Device: Synthetic osmotic dilators",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Transcervical single-balloon catheter","A single-balloon (Foley) catheter will be placed through the cervix and filled to 30cc of water or saline. The balloon will remain in the participant until their procedure, usually 3-4 hours, or earlier if it falls out on its own.",[9],[27],"Foley catheter",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Synthetic osmotic dilators","Dilators will be maintained in the cervix between 3-4 hours, during which each dilator rod will swell several times its initial dried diameter.",[15],[33],"Dilapan-S, seaweed laminaria",[35],{"name":36,"affiliation":37,"role":38},"Anjanique Mariquit Lu, MD","Boston Medical Center, Obstetrics and Gynecology","PRINCIPAL_INVESTIGATOR",[40,45],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","617 414 5716",null,"anjaniquemariquit.lu@bmc.org",{"name":46,"role":41,"phone":47,"phoneExt":43,"email":48},"Alana Martinusen, MPH","617 383 3500","alana.martinusen@bmc.org",[50],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"RECRUITING","Boston","Massachusetts","02118","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-71.05977,42.35843,{"lat":61,"lon":60},[64,67],{"name":65,"role":41,"phone":66,"phoneExt":43,"email":44},"Anjanique M Lu, MD","617-414-5716",{"name":68,"role":41,"phone":42,"phoneExt":43,"email":69},"Pauline Yang, BS","yangp@bu.edu",{"type":71,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100577496",false,"NCT06799052","Cervical Preparation for Same-Day Dilation & Evacuation","Same-Day Cervical Preparation Prior to Second Trimester Dilation & Evacuation: A Noninferiority Randomized Control Trial Comparing Single-Balloon Catheter and Osmotic Dilators","Inclusion Criteria:\n\n* Between 16 weeks 0 days - 18 weeks 6 days gestational age who are pursuing termination, based on reliable gestational age (defined as ultrasonography performed by a clinical provider, or a certain last menstrual period)\n* Able to provide informed consent\n* English- or Spanish-speaking\n* Singleton intrauterine pregnancy\n\nExclusion Criteria:\n\n* Allergy to betadine, aquacryl hydrogel, latex-free silicone single-balloon catheter, synthetic or natural osmotic dilators\n* Fetal demise or known fetal anomaly\n* BMI \\>45\n* Incarceration or other inability to give informed consent\n* Decide to undergo cervical preparation overnight prior to next-day D\\&E",true,"FEMALE","16 Years",{"count":82,"type":83},32,"ESTIMATED","INTERVENTIONAL",[86],"NA","This is a noninferiority randomized control trial of two cervical preparation methods prior to same-day Dilation \\& Evacuation (D\\&E). Cervical preparation is a process that softens and dilates the cervix prior to a procedure.\n\nThe primary objective is to evidence noninferiority of cervical preparation using a single-balloon catheter method when compared to a group receiving osmotic dilators, specifically in D\\&E operative time.\n\nSecondary objectives will compare the two methods for adequate dilation, ability to complete the operation in the same day, participant pain, satisfaction and safety.",[89,90,91],"Abortion, Second Trimester","Procedural Pain","Procedural Complication",[93,23,94,95,96],"Cervical Dilation and Evacuation (D&E)","Osmotic dilators","Adequate dilation","Patient satisfaction","2026-06-29",{"date":99,"type":100},"2026-06-30","ACTUAL",{"date":102,"type":100},"2025-06-12",{"date":104,"type":83},"2026-12",{"name":5,"class":6},1]