Intravenous Insulin Versus Subcutaneous Insulin Infusion in Intrapartum Management of Pregnant Women With Type 1 Diabetes Mellitus: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Neonatal Hypoglycemia
研究概览
简要总结
The purpose of this study is to perform a randomized trial to investigate if intrapartum insulin delivery mechanisms reduces adverse outcomes associated with type 1 diabetes in pregnancy. The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to the primary outcome of neonatal blood sugar.
详细描述
Intrapartum glucose management is critical to reducing neonatal hypoglycemia shortly after birth. Some providers are comfortable continuing patients on their subcutaneous insulin pump during labor while others transition these patients to intravenous insulin infusions. Previous literature has retrospectively shown this to be both a feasible and safe option.
The investigators aim to compare subcutaneous insulin pump versus intravenous insulin infusion with regard to obstetric and neonatal outcomes.
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
- Single (Outcomes Assessor)
盲法说明
Those assessing the outcomes from the medical chart will be blinded to the randomization process and the assigned study arm. Patients, the primary investigator, and their care providers will be aware of their treatment status.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with pre-gestational diagnosis of type 1 diabetes mellitus and managed on an insulin pump in pregnancy
- •Pregnancy and delivery care obtained at University of Massachusetts (UMass) Memorial Medical Center
- •Patients able to provide written informed consent
排除标准
- •Patients who are under the age of 18
- •Patients with altered state of consciousness
- •Critically ill patient requiring intensive care unit admission
- •Patient at risk for suicide
- •Patient refuses or is otherwise unable to participate in own care
- •Patient without pump supplies
- •Patients presenting with diabetic ketoacidosis on admission
研究组 & 干预措施
Intravenous Insulin Infusion
Patients will be randomized to discontinuation of the CSII pump intrapartum and initiation of IV insulin infusion per hospital protocol.
干预措施: Insulin (Drug)
Continuous Subcutaneous Insulin Infusion (CSII)
Patients will be randomized to continuation of their CSII pump intrapartum and will be managed in accordance with the CSII hospital protocol.
干预措施: Insulin (Drug)
结局指标
主要结局
Neonatal Hypoglycemia
时间窗: Within 2 hours of birth
First neonatal blood sugar obtained within 2 hours of birth
次要结局
- Number of Maternal Hypoglycemic Events(During labor)
- Development of Diabetic Ketoacidosis During Labor(During Labor)
- Gestational Age at Delivery(At birth)
- Number of Participants With Neonatal Hyperbilirubinemia(Within first 2 days of life)
- Number of Participants With Shoulder Dystocia(At birth)
- Number of Participants With Brachial Plexus Injury(At birth)
- Received Neonatal Intervention for Hypoglycemia(Within 24 hours of life)
- Neonatal Intensive Care Unit Admission(At delivery and within first 2 day of life)
- Mode of Delivery(At birth)
- Neonatal Birthweight(At Birth)
- 5 Minute Apgar Score < 7(At delivery (5 minutes))
- Number of Participants With Neonatal Respiratory Distress(At delivery)
研究者
Gianna Wilkie
Principal Investigator
University of Massachusetts, Worcester