Intrapartum Glucose Monitoring of GDM: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Neonatal Hypoglycemia
研究概览
简要总结
The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •All female patients of reproductive age who have the diagnosis GDM
- •Patient with singleton gestation presenting in labor or for induction
排除标准
- •Patients below the age of 18
- •Multiple gestation pregnancy
- •Patients undergoing scheduled c-section
研究组 & 干预措施
Infrequent testing
Finger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater)
干预措施: Fingerstick (Other)
Frequent testing
Finger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater)
干预措施: Fingerstick (Other)
结局指标
主要结局
Neonatal Hypoglycemia
时间窗: end of study at 6 months
Glucose values of neonate measured in mg/dL
次要结局
未报告次要终点
研究者
Thomas Owens
Principal Investigator
Icahn School of Medicine at Mount Sinai