[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537119":3},{"organization":4,"outcomesModule":7,"designInfo":58,"detailedDescription":57,"studyPopulation":61,"armGroups":62,"interventions":71,"overallOfficials":80,"centralContacts":85,"locations":94,"responsibleParty":122,"collaborators":57,"id":124,"slug":57,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":57,"eligibilityCriteria":128,"healthyVolunteers":125,"sex":129,"minAge":130,"maxAge":57,"enrollmentInfo":131,"targetDuration":57,"studyType":134,"phases":57,"briefSummary":135,"conditions":136,"keywords":139,"overallStatus":97,"whyStopped":57,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Inova Health Care Services","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Hemoglobin levels on postoperative day one","Change in hemoglobin levels reported in gram per deciliter on postoperative day one, calculated as the difference between immediate preoperative and postoperative day 1 hemoglobin levels","preoperatively and one day after surgery",[14,17,21,24,28,31,35,39,43,47,51,54],{"measure":15,"description":16,"timeFrame":12},"Completion rate of sterilization","Proportion of sterilization procedure completed by postoperative day one",{"measure":18,"description":19,"timeFrame":20},"Total procedure estimated blood loss","estimated blood loss calculated and documented in milliliters at the end of the procedure","intraoperatively",{"measure":22,"description":23,"timeFrame":20},"Adjacent organ damage","Rate of injury to abdominal\u002Fpelvic organs sustained during the procedure",{"measure":25,"description":26,"timeFrame":27},"Need for blood transfusion","any need for blood products transfusion intraoperatively through discharge","from day of surgery up to 30 days pospartum",{"measure":29,"description":30,"timeFrame":20},"Total operative time","time necessary to complete the surgery from skin incision to end of skin closure",{"measure":32,"description":33,"timeFrame":34},"ICU admission","any admission to the intensive care unit for procedure-related complications","from day of surgery up to 7 days postpartum",{"measure":36,"description":37,"timeFrame":38},"Length of hospital stay","Duration of hospitalization in days from admission to discharge","from day of surgery up to 6 weeks postpartum",{"measure":40,"description":41,"timeFrame":42},"Hospital readmission postoperatively","Any admission after initial discharge from the hospital","Day of initial dischage through 6 weeks postpartum",{"measure":44,"description":45,"timeFrame":46},"Reoperation rates","Number of participants who return to the operating room due to initial procedure-related complications","postoperative day 0 through 6 weeks postpartum",{"measure":48,"description":49,"timeFrame":50},"Pain score","pain severity measured on a scale of 0 through 10","from day of surgery up to 7 days postparum",{"measure":52,"description":53,"timeFrame":46},"Surgical site infection","any infection that occurs post-surgery in the abdomen, pelvis, abdominal walls or skin",{"measure":55,"description":56,"timeFrame":20},"Cost","cost difference between bipolar instrument and suture",null,{"allocation":57,"interventionModel":57,"interventionModelDescription":57,"primaryPurpose":57,"observationalModel":59,"timePerspective":60,"maskingInfo":57},"COHORT","RETROSPECTIVE","Patients aged 21 years or older undergoing permanent sterilization at the time of cesarean delivery at 24 weeks' gestation or beyond, 21 years old and older",[63,67],{"label":64,"type":57,"description":57,"interventionNames":65},"Complete salpingectomy using a hand-held bipolar energy instrument",[66],"Other: Hand-held bipolar energy instrument",{"label":68,"type":57,"description":57,"interventionNames":69},"Complete salpingectomy using traditional suture ligation",[70],"Other: Traditional suture ligation",[72,76],{"type":6,"name":73,"description":74,"armGroupLabels":75,"otherNames":57},"Hand-held bipolar energy instrument","A bipolar energy instrument is used for complete salpingectomy at the time of cesarean delivery.",[64],{"type":6,"name":77,"description":78,"armGroupLabels":79,"otherNames":57},"Traditional suture ligation","Traditional suture ligation technique is used for complete salpingectomy at the time of cesarean delivery.",[68],[81],{"name":82,"affiliation":83,"role":84},"Jean W Thermolice, MD","Inova Fairfax Medical Campus","PRINCIPAL_INVESTIGATOR",[86,90],{"name":82,"role":87,"phone":88,"phoneExt":57,"email":89},"CONTACT","703-531-3000","jean.thermolice@inova.org",{"name":91,"role":87,"phone":92,"phoneExt":57,"email":93},"Bianca Nguyen, MD","512-750-9573","bianca.nguyen@inova.org",[95],{"facility":96,"status":97,"city":98,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"Inova Fairfax Medical campus","RECRUITING","Falls Church","Virginia","22042","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-77.17109,38.88233,{"lat":107,"lon":106},[110,111,112,115,116,118,120],{"name":82,"role":87,"phone":88,"phoneExt":57,"email":89},{"name":91,"role":87,"phone":57,"phoneExt":57,"email":93},{"name":113,"role":114,"phone":57,"phoneExt":57,"email":57},"Sofia Girald-Berlingeri, MD","SUB_INVESTIGATOR",{"name":91,"role":114,"phone":57,"phoneExt":57,"email":57},{"name":117,"role":114,"phone":57,"phoneExt":57,"email":57},"Catherine Kim, MD",{"name":119,"role":114,"phone":57,"phoneExt":57,"email":57},"Miranda Newell, MS",{"name":121,"role":114,"phone":57,"phoneExt":57,"email":57},"Renee Brenner, BS",{"type":123,"investigatorFullName":57,"investigatorTitle":57,"investigatorAffiliation":57,"oldNameTitle":57,"oldOrganization":57},"SPONSOR","100537119",false,"NCT06273683","Comparison of Two Salpingectomy Techniques for Sterilization at the Time of Cesarean Delivery","Inclusion Criteria:\n\n* request for permanent sterilization at the time of cesarean delivery\n* 24 weeks' gestation or beyond\n* 21 years old or older\n* Medicaid sterilization consent per Virginia Department of Medical Assistance Services regulations (if Medicaid recipient).\n\nExclusion Criteria:\n\n* vaginal delivery\n* history of prior adnexal surgery (such as prior bilateral tubal ligation or unilateral salpingectomy oophorectomy)\n* placenta accreta spectrum\n* placenta previa\n* history of bleeding diathesis.","FEMALE","21 Years",{"count":132,"type":133},900,"ESTIMATED","OBSERVATIONAL","One in three women of reproductive age utilize tubal sterilization for contraception, and sterilization is often requested at time of cesarean delivery. Complete salpingectomy for the purpose of permanent sterilization at the time of cesarean birth is increasingly being performed worldwide.\n\nA preferred complete salpingectomy technique for the purpose of sterilization at the time of cesarean delivery has not emerged in current practice. The objective is to compare short-term clinical outcomes and cost of salpingectomy using a hand-held bipolar energy instrument with those of traditional suture ligation. This retrospective cohort study will be conducted from 2017-2023 at a single tertiary care hospital. The investigators hypothesize that bipolar energy instrument use will not significantly improve clinical outcomes.",[137,138],"Permanent Sterilization","Pregnancy Related",[140],"Sterilization, salpingectomy, cesarean delivery","2026-03-03",{"date":143,"type":144},"2026-03-05","ACTUAL",{"date":146,"type":144},"2024-03-11",{"date":148,"type":133},"2027-12",{"name":5,"class":6},1]