Intrapartum Maternal Glucose Control and Effect on Neonatal Hypoglycemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 2
- 主要终点
- Immediate postnatal Neonatal hypoglycemia
研究概览
简要总结
The purpose of this study is to assess whether a liberal intrapartum glycemic target range compared to usual care standard control ranges will lead to a decrease in the rate of neonatal hypoglycemia among pregnant patients in labor with diabetes.
详细描述
Neonatal hypoglycemia is a leading cause of admission to the neonatal ICU (NICU) and is associated with increased costs, separation from mothers, and when severe, long term neurological sequelae. Prior research has suggested an association between intrapartum maternal glucose and the risk of neonatal hypoglycemia, so current insulin administration protocols aimed to maintain the blood glucose close to 100mg/dl.
However, recent studies have found inconsistent evidence of a relationship between intrapartum maternal glucose and neonatal hypoglycemia, Furthermore, on review of previously established protocols, improved maternal glucose control came with an increased frequency of neonatal hypoglycemia. Thus, these findings have suggested that relaxing the intrapartum goals for maternal glucose may be associated with improved neonatal outcomes.
Few randomized controlled trials (RCTs) exist in evaluating neonatal outcomes comparing liberal versus tight intrapartum glycemic control. Recent RCTs have found that tight maternal glucose control in labor was associated with lower mean neonatal blood glucose levels in the first 24 hours of life. While another recent RCT found that a permissive blood glucose (up to 180mg/dl) threshold was associated with equivalent neonatal blood glucose levels when compared to the standard, strict thresholds (up to 110mg/dl).
In this study, participants will be recruited at delivery planning outpatient visits or at admission to labor and delivery and stratified by type of diabetes into two groups, either Type 1 Diabetes or Gestational Diabetes(GDM)/Type 2 diabetes. They will then be randomized to one of two intervention groups. The liberalized treatment group will have a target Glucose Range 70 - 160mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound. The standard treatment Group will have a glucose target Glucose Range 70 - 110mg/dl and receive treatment via insulin drip will be initiated if the blood sugar exceeds the upper bound.
The specific aim of this project is to determine the effectiveness of liberalized intrapartum glycemic targets in reducing the incidence of neonatal hypoglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant patients with Pre-gestational (Type 1 or Type 2) or Gestational Diabetes
- •Singleton Gestations
- •Greater than or equal to 35 weeks gestation
- •Planned for vaginal delivery at the University of Pittsburgh Medical Center Magee-Womens Hospital (UPMC MWH)
排除标准
- •Major fetal anomalies anticipated to require NICU admission
- •Planned Cesarean delivery
研究组 & 干预措施
Standard Intrapartum Glucose Target Range
The goal intrapartum glucose target range will be 70-110mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 110 mg/dL.
干预措施: Standard Intrapartum Glucose Target Range (Other)
Liberalized Intrapartum Glucose Target Range
The goal intrapartum glucose target range will be 70-160mg/dl. Insulin infusion will be initiated when maternal capillary glucose exceeds 160 mg/dL.
干预措施: Liberalized Intrapartum Glucose Target Range (Other)
结局指标
主要结局
Immediate postnatal Neonatal hypoglycemia
时间窗: Within the first 24 hours after delivery.
Number of newborns with neonatal hypoglycemia, defined as a blood glucose of less than 45mg/dL
次要结局
- Any neonatal hypoglycemia(Prior to neonatal discharge, up to 42 days after delivery.)
- Mean neonatal blood glucose(Prior to neonatal discharge, up to 42 days after delivery.)
- Neonatal Hypoglycemia Requiring IV Treatment(Prior to neonatal discharge, up to 42 days after delivery.)
- NICU admission(Prior to discharge, up to 42 days after delivery.)
- Maternal Intrapartum Hyperglycemia(During labor( for up to 200 hours))
- Maternal intrapartum hypoglycemia(During labor( for up to 200 hours))
- Mean maternal intrapartum blood glucose(During labor( for up to 200 hours))
研究者
Praveen Ramesh
Fellow Physician, Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences
University of Pittsburgh