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

ConditionDysglycemia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-50
SponsorIcahn School of Medicine at Mount Sinai

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Continuous Glucose Monitor

    Device

    Continuous glucose monitor during perioperative Cesarean delivery

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: scheduled term c-section1 intervention

Trial outcomes

Primary outcomes

1

interstitial glucose from CGM device

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

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

Secondary outcomes

1

Number of surgical site infection

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

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

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: