[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07671599":3,"trial-entities:NCT07671599":90,"trial-summary:NCT07671599":93},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":17,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":33,"secondary_outcomes":38,"sex":43,"minimum_age":44,"maximum_age":45,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":58,"locations":60,"central_contacts":77,"overall_officials":84,"references":88,"see_also_links":89},"NCT07671599","STUDY-26-00229","Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)","Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE): A Pilot Study","NOT_YET_RECRUITING","2028-05","2026-06","2026-06-26","2026-09","Icahn School of Medicine at Mount Sinai","OTHER",false,"This prospective pilot study is exploratory in nature and is designed to evaluate the validity of continuous glucose monitor (CGM) use for perioperative glucose surveillance during scheduled Cesarean delivery for nondiabetic patients. Primary objective is characterization of perioperative glucose trends during elective Cesarean delivery in patients without diabetes and exploratory analyses will describe perioperative glucose patterns captured by CGM. Secondary objective is to examine rates of and associations with post-operative complications, including surgical site infections.",null,[19],"Dysglycemia",[],"OBSERVATIONAL",[],{"count":24,"type":25},150,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31},"DEVICE","Continuous Glucose Monitor","Continuous glucose monitor during perioperative Cesarean delivery",[32],"scheduled term c-section",[34],{"measure":35,"description":36,"timeFrame":37},"interstitial glucose from CGM device","glucose of interstitial fluid as measured by CGM device on participant's arm","from pre-operative appointment through end of postpartum hospital stay, up to ten days",[39],{"measure":40,"description":41,"timeFrame":42},"Number of surgical site infection","Diagnosis of surgical site infection as a measure of post-operative complications","Post-op through end of postpartum hospital say, up to ten days.","ALL","18 Years","50 Years",{"inclusion":47,"exclusion":52,"raw_text":57},[48,49,50,51],"singleton pregnancy","no prior diagnosis of diabetes (gestational included)","scheduled term cesarean delivery in Mount Sinai Health System","aged 18-50 years",[53,54,55,56],"preexisting diabetes mellitus","diagnosis of gestational diabetes mellitus (GDM) in the current pregnancy, based on standard prenatal screening","known endocrine disorder affecting glucose metabolism (such as Cushing syndrome, poorly controlled thyroid disorder, etc.)","use of antenatal steroids within the two weeks prior to delivery","Inclusion Criteria:\n\n* singleton pregnancy\n* no prior diagnosis of diabetes (gestational included)\n* scheduled term cesarean delivery in Mount Sinai Health System\n* aged 18-50 years\n\nExclusion Criteria:\n\n* preexisting diabetes mellitus\n* diagnosis of gestational diabetes mellitus (GDM) in the current pregnancy, based on standard prenatal screening\n* known endocrine disorder affecting glucose metabolism (such as Cushing syndrome, poorly controlled thyroid disorder, etc.)\n* use of antenatal steroids within the two weeks prior to delivery",[59],"ADULT",[61],{"facility":13,"city":62,"state":62,"zip":63,"country":64,"contacts":65,"geoPoint":74},"New York","10029","United States",[66,71],{"name":67,"role":68,"phone":69,"email":70},"Nicola F Tavella, MPH","CONTACT","2122413888","nicola.tavella@mssm.edu",{"name":72,"role":73},"Angela Bianco","PRINCIPAL_INVESTIGATOR",{"lat":75,"lon":76},40.71427,-74.00597,[78,80],{"name":67,"role":68,"phone":79,"email":70},"(212) 241-3888",{"name":81,"role":68,"phone":82,"email":83},"Kavya Shivashankar, MD","(212) 241-5681","kavya.shivashankar@mssm.edu",[85],{"name":86,"affiliation":87,"role":73},"Angela Bianco, MD","Faculty",[],[],{"nct_id":4,"conditions":91,"biomarkers":92},[19],[],{"nct_id":4,"found":94,"summary":95,"prompt_version":105},true,{"design":96,"status":97,"heading":98,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This is an observational study involving 150 participants. It is a pilot study, meaning it's an initial exploration of the topic.","completed","Continuous Glucose Monitoring During Cesarean Delivery (PERUSE)","This study, called PERUSE, is looking at how continuous glucose monitors (CGMs) work for people having a scheduled C-section. CGMs are small devices that track your sugar levels. We want to understand how blood sugar changes during and after surgery in people who don't have diabetes. We'll also see if these sugar patterns are linked to problems after surgery, like infections. You might be able to join if you are 18-50 years old, have a single pregnancy, and are scheduled for a C-section at Mount Sinai Health System, and do not have a history of diabetes.","Your interstitial glucose will be measured from your pre-operative appointment through the end of your postpartum hospital stay, up to ten days.",96,"You would use a Continuous Glucose Monitor (CGM) from your pre-operative appointment through the end of your hospital stay after delivery, up to ten days.","Not stated in the trial record.",[29],"v2"]