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NCT Number: NCT07671599

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

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.

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Key information

Conditions

Dysglycemia

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location contact

Angela Bianco

PRINCIPAL_INVESTIGATOR

Nicola F Tavella, MPH

CONTACT

[email protected]

2122413888

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor

Device

Continuous glucose monitor during perioperative Cesarean delivery

Primary outcomes

  1. interstitial glucose from CGM device

    Time frame: from pre-operative appointment through end of postpartum hospital stay, up to ten days

    glucose of interstitial fluid as measured by CGM device on participant's arm

Secondary outcomes

  1. Number of surgical site infection

    Time frame: Post-op through end of postpartum hospital say, up to ten days.

    Diagnosis of surgical site infection as a measure of post-operative complications

Study contacts

Contact information is provided by the study sponsor or research team.

Kavya Shivashankar, MD

CONTACT

[email protected]

(212) 241-5681

Nicola F Tavella, MPH

CONTACT

[email protected]

(212) 241-3888

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE): A Pilot Study

Acronym: PERUSE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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