About this trial
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
This trial does not accept healthy volunteersQualifiers
singleton pregnancy
no prior diagnosis of diabetes (gestational included)
scheduled term cesarean delivery in Mount Sinai Health System
aged 18-50 years
Disqualifiers
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
Trial population
continuous glucose monitor (CGM) use for perioperative glucose surveillance during scheduled Cesarean delivery for nondiabetic patients
Trial design
Cohort
Prospective
Treatments tested in this trial
Continuous Glucose Monitor
DeviceContinuous glucose monitor during perioperative Cesarean delivery
Treatment groups
Trial outcomes
Primary outcomes
interstitial glucose from CGM device
glucose of interstitial fluid as measured by CGM device on participant's arm
Secondary outcomes
Number of surgical site infection
Diagnosis of surgical site infection as a measure of post-operative complications
Sponsors and contacts
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