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NCT07671599
Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)
Conditions: Dysglycemia
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Enrollment: 150
Sponsor: Icahn School of Medicine at Mount Sinai
Location: Icahn School of Medicine at Mount Sinai New York New York
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* singleton pregnancy
* no prior diagnosis of diabetes (gestational included)
* scheduled term cesarean delivery in Mount Sinai Health System
* aged 18-50 years
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07671599). StuddyBuddy aggregates publicly available trial information.