Intrapartum Glycemic Control With Insulin Infusion Versus Rotating Fluids: Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 4
- 主要终点
- Neonatal blood glucose value
研究概览
简要总结
This study will determine whether rotating intravenous (IV) fluid is better than receiving insulin to control a baby's blood sugar after delivery in laboring women with diabetes. A computer will choose the method of controlling the participant's blood sugar while they are in labor.
详细描述
Diabetes complicates 6-9% of all pregnancies. Of those pregnancies, 90% of pregnant diabetics have gestational diabetes mellitus (GDM), while the remainder of patients have pre-existing diabetes mellitus (DM). Maternal hyperglycemia has a negative impact on maternal and fetal/neonatal health. Adverse neonatal outcomes include birth injuries, respiratory distress, and metabolic derangements such as hypoglycemia. The incidence of neonatal hypoglycemia is higher in pregnancies complicated by pre-existing DM (24-48%) when compared to patients with GDM (16-19%).
Neonatal hypoglycemia causes immediate and long-term morbidity. Treatment of hypoglycemia may require admission to the Neonatal Intensive Care Unit (NICU). The severity and duration of neonatal hypoglycemia raises concern for permanent neurologic damage to the neonate. Even transient episodes of neonatal hypoglycemia have been associated with neurodevelopmental impairment. It is imperative that measures be taken in diabetic mothers (both pre-existing and gestational) to minimize the risk of neonatal hypoglycemia. While antepartum maternal glucose control remains an important factor in preventing neonatal complications, prevention of maternal hyperglycemia during the intrapartum period has been shown to reduce the risk of neonatal hypoglycemia.
Therapies utilized for maternal intrapartum glycemic control across academic centers in the United States include the use of insulin and rotation of intravenous (IV) fluids. Although used in clinical practice for intrapartum glycemic control, the impact of rotating IV fluids on neonatal blood glucose is unknown. The potential for using rotating IV fluids to control intrapartum blood glucose has several advantages over using insulin for optimization of blood glucose. There is minimal risk of maternal hypoglycemia using IV fluids when compared to insulin therapy. There is also less risk of medication error. IV fluids are easily administered as they do not require separate peripheral access and are easily accessible on a Labor and Delivery (L&D) unit.
The investigators propose a randomized controlled trial (RCT) to assess the effect of maternal intrapartum glycemic control with rotating IV fluids compared to insulin infusion on neonatal blood glucose levels within two hours of birth. The investigators hypothesize neonates born to mothers managed by rotating fluids will have higher neonatal blood glucose levels (closer to normal range) within two hours of birth compared to neonates born to mothers managed by insulin infusion.
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
- None
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women with Type II diabetes mellitus or GDM controlled with insulin and/or hypoglycemic medication (GDMA2)
- •Singleton pregnancies
- •Gestational age between 37 0/7 weeks and 40 0/7 weeks
- •Planned delivery at a Geisinger Medical Center (GMC) or Geisinger Wyoming Valley (GWV)
- •English or Spanish speaking
- •Anticipated delivery at ≥ 4 hours from randomization (e.g., cervical dilation at ≤ 7 cm at time of randomization)
排除标准
- •Women with Type 1 diabetes mellitus or use of insulin pump
- •Evidence of diabetic ketoacidosis at time of admission for delivery
- •Multifetal gestation
- •Gestational age < 37 0/7 weeks or > 40 0/7 weeks
- •Non-English or Non-Spanish speaking
- •Anticipated delivery < 4 hours from randomization (e.g., cervical dilation > 7 cm at time of randomization, first cesarean delivery of the day)
- •Oral corticosteroid use within 48 hours of planned delivery
- •Antenatal corticosteroid use within 7 days of admission for delivery
- •Delivery planned outside of GMC or GWV
- •Fetal demise
- •Prenatal diagnosis of lethal fetal anomaly
- •Active infection or immunocompromised state (e.g., HIV/AIDS, active malignancy, use of immunosuppressant medication) at time of admission for delivery
结局指标
主要结局
Neonatal blood glucose value
时间窗: Within 2 hours of life
Neonatal blood glucose value from birth to 2 hours of life
次要结局
- Incidence of composite neonatal outcome(First 24 hours of life until discharge (average time 21 days))
- Mean neonatal blood glucose value(First 24 hours of life)
- Incidence of maternal hypoglycemia(During labor (average time 24 hours))
- Mean intrapartum maternal blood glucose value(During labor (average time 24 hours))
- Maternal blood glucose value before delivery(Within one hour of delivery)