Intrapartum Glucose Management Among Women With Gestational Diabetes Mellitus and Its Impact on Neonatal Blood Glucose Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Mean neonatal blood glucose levels
研究概览
简要总结
Gestational Diabetes Mellitus (GDM) is one of the most common medical complications of pregnancy. Neonatal hypoglycemia is a common and well described complication for infants born to mothers with GDM and diabetes mellitus (DM) and studies have linked intrapartum maternal glucose levels with neonatal hypoglycemia. While guidelines exist to guide practitioners in how to best manage intrapartum maternal glucose levels among Type I and and Type II DM, there is a paucity of data guiding practitioners in the intrapartum management of blood glucose levels for women with GDM, particularly those treated with insulin antepartum. The goal of this project is to compare two protocols of intrapartum glucose management in women with GDM and investigate the impact on neonatal blood glucose levels.
详细描述
Research objective- To compare "Tight" vs. "Less Tight" intrapartum glucose management
Hypothesis: Neonates born to mothers managed via the "Less Tight" intrapartum glucose management protocol will have lower mean glucose levels in the first 24 hours of life when compared to mean glucose levels among infants born to mothers managed via the "Tight" intrapartum glucose management protocol.
Study Design: Randomized trial
Population: English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital
Once enrolled, patients will then be randomized to "Tight" or "Less Tight" intrapartum glucose control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •English or Spanish speaking women with a diagnosis of GDM managed at the Diabetes in Pregnancy Program at Women & Infants Hospital, with a plan to deliver at Women & Infants Hospital
排除标准
- •Pre-existing DM, multiple gestations, major fetal anomalies anticipated to require NICU admission, planned cesarean delivery, medications known to effect glucose metabolism other than insulin (i.e. metformin)
研究组 & 干预措施
Tight control
Intervention Standard Care:
Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60 mg/dL
干预措施: Standard Protocol for intrapartum glucose management (Other)
Less tight control
Intervention:
Less Tight glucose control protocol: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60mg/dL
干预措施: Experimental Protocol for intrapartum glucose management (Other)
结局指标
主要结局
Mean neonatal blood glucose levels
时间窗: 24 hours
次要结局
- Neonatal Intensive Care Unit (NICU) admission(Birth of neonate until time of discharge of neonate to home up to 7 days)
- Hours in Neonatal Intensive Care Unit (NICU)(Birth of neonate until time of discharge of neonate to home up to 7 days)
- Maternal hypoglycemia(Intrapartum period)
研究者
Maureen Hamel
Maureen S. Hamel MD
Women and Infants Hospital of Rhode Island