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Not yet recruiting NCT07671599

Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE)

Observational Dysglycemia

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗