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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07671599
Acronym
PERUSE
Enrollment
150
Registered
2026-06-26
Start date
2026-09-01
Completion date
2028-05-01
Last updated
2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysglycemia

Brief 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.

Interventions

DEVICEContinuous Glucose Monitor

Continuous glucose monitor during perioperative Cesarean delivery

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
interstitial glucose from CGM devicefrom pre-operative appointment through end of postpartum hospital stay, up to ten daysglucose of interstitial fluid as measured by CGM device on participant's arm

Secondary

MeasureTime frameDescription
Number of surgical site infectionPost-op through end of postpartum hospital say, up to ten days.Diagnosis of surgical site infection as a measure of post-operative complications

Countries

United States

Contacts

CONTACTNicola F Tavella, MPH
nicola.tavella@mssm.edu(212) 241-3888
CONTACTKavya Shivashankar, MD
kavya.shivashankar@mssm.edu(212) 241-5681
PRINCIPAL_INVESTIGATORAngela Bianco, MD

Faculty

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026