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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| scheduled term c-section | Patients scheduled for term cesarean deliveries and who are screened eligible and consented will be administered a continuous glucose monitor prior to their c-section, and they will wear the device through their stay in the hospital. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Glucose Monitor | Device | Continuous glucose monitor during perioperative Cesarean delivery |
|
| Measure | Description | Time Frame |
|---|---|---|
| interstitial glucose from CGM device | glucose of interstitial fluid as measured by CGM device on participant's arm | from pre-operative appointment through end of postpartum hospital stay, up to ten days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of surgical site infection | Diagnosis of surgical site infection as a measure of post-operative complications | Post-op through end of postpartum hospital say, up to ten days. |
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Inclusion Criteria:
Exclusion Criteria:
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continuous glucose monitor (CGM) use for perioperative glucose surveillance during scheduled Cesarean delivery for nondiabetic patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola F Tavella, MPH | Contact | (212) 241-3888 | nicola.tavella@mssm.edu | |
| Kavya Shivashankar, MD | Contact | (212) 241-5681 | kavya.shivashankar@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Angela Bianco, MD | Faculty | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).
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