Perioperative Use of Continuous Glucose Monitoring for Scheduled Cesarean Deliveries (PERUSE): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- interstitial glucose from CGM device
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •singleton pregnancy
- •no prior diagnosis of diabetes (gestational included)
- •scheduled term cesarean delivery in Mount Sinai Health System
- •aged 18-50 years
排除标准
- •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
结局指标
主要结局
interstitial glucose from CGM device
时间窗: 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
次要结局
- Number of surgical site infection(Post-op through end of postpartum hospital say, up to ten days.)
研究者
Angela Bianco
Director, Division of Maternal-Fetal Medicine
Icahn School of Medicine at Mount Sinai