Detemir Versus NPH for Type 2 Diabetes Mellitus in Pregnancy: a Comparative-effectiveness, Open Label, Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of Neonates With Composite Adverse Neonatal Outcome
研究概览
简要总结
To determine whether use of detemir compared to neutral protamine hagedorn (NPH) decreases rates of composite neonatal outcome and maternal hypoglycemia events in women with Type 2 Diabetes Mellitus (T2DM).
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
- 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
- •Preexisting type 2 diabetes mellitus requiring medical treatment or
- •overt diabetes diagnosed prior to 20 weeks of gestation using either Hemoglobin A1c (HBA1C) ≥ 6.5 or fasting glucose ≥126 mg/dl or random blood glucose ≥ 200 mg/dl or two step method ( 50g glucose challenge test (GCT) >135 mg/dl followed by 100 GCT with at least 2 values above thresholds: Fasting Blood Glucose (FBG) >90, 1 hr >180, 2 hr > 155, 3 hr > 140 mg/dl).
- •Gestational age ≤20 weeks
- •Willing to start insulin therapy or to continue insulin treatment during pregnancy
- •Singleton or twin pregnancy
排除标准
- •Known allergy/prior adverse reaction to NPH/detemir
- •Patients <18y
- •Known major fetal anomalies
- •Diabetic nephropathy (Creatinine (Cr)≥1.5)
- •Diabetic proliferative retinopathy
- •Patients with Type 1 diabetes or gestational diabetes
研究组 & 干预措施
Neutral Protamine Hagedorn (NPH)
NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
干预措施: Neutral Protamine Hagedorn (NPH) (Drug)
Detemir
Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
干预措施: Detemir insulin (Drug)
结局指标
主要结局
Number of Neonates With Composite Adverse Neonatal Outcome
时间窗: From the time of delivery to the time of discharge (about 2-14 days)
Composite Adverse Neonatal Outcome includes 1 or more of any of the following: * Neonatal intensive care unit (NICU) admission or * Neonatal hypoglycemia (\<40 mg/dL in the first 24 hours of life and less than 50 mg/dL after) or requiring medical therapy or * Respiratory distress (need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure or ventilation at the first 24 hours of life or * Shoulder dystocia - defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head in order to deliver the fetal body after the fetal head has been delivered or * Large for gestational age (LGA) -weight over 90th percentile of the expected value according to gestational age or * Macrosomia- Fetal weight above 4000g
次要结局
- Number of Maternal Subjects Who Experienced Hypoglycemic Events (<60 mg/dL) During Pregnancy(perinatal to postpartum (32 weeks))
- Number of Subjects Who Had Cesarean Delivery(at delivery)
- Number of Neonates Who Where Small for Gestational Age (SGA)(at delivery)
- Neonatal Hospital Admission Days(From the time of delivery to the time of discharge (about 2-14 days))
- Maternal Mean Post Prandial Glucose(perinatal to postpartum (32 weeks))
- Change in Maternal Weight During Pregnancy(perinatal to postpartum (32 weeks))
- Gestational Weeks at Delivery(at delivery)
- Maternal Mean Fasting Glucose(perinatal to postpartum (32 weeks))
- Number of Maternal Subjects Who Had Hypertensive Disorder During Pregnancy(perinatal to postpartum (32 weeks))
- Number of Subjects Who Had Operative Vaginal Delivery(at delivery)
- Number of Neonates Who Had Jaundice Requiring Therapy(From the time of delivery to the time of discharge (about 2-14 days))
- Number of Maternal Subjects Who Had Preeclampsia With Severe Features(perinatal to postpartum (32 weeks))
- # of Neonates Who Had 5-minute Apgar Score < 7(5 minutes after delivery)
研究者
Michal Fishel Bartal
Assistant Professor of OB GYN
The University of Texas Health Science Center, Houston