Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitor.
- Who it may be relevant to
- Registry conditions: Dysglycemia. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE): A Pilot Study
Overview
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.
Interventions
- Device Continuous Glucose Monitor
Continuous glucose monitor during perioperative Cesarean delivery
Primary outcome measures
- interstitial glucose from CGM device [Time frame: from pre-operative appointment through end of postpartum hospital stay, up to ten days]
Secondary outcome measures (1)
- Number of surgical site infection [Time frame: Post-op through end of postpartum hospital say, up to ten days.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT07671599 · STUDY-26-00229