Tight Versus Standard Glycemic Targets for Pregnant Women With Gestational Diabetes and Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Difference in birth weight
研究概览
简要总结
The purpose of this randomized clinical trial is to determine whether glycemic targets that are lower than those currently recommended by the American Diabetes Association (ADA) and the American College of Obstetricians and Gynecologists (ACOG) would improve overall outcomes in pregnant patients with diabetes. Eligible pregnant women with a diagnosis of gestational diabetes or Type 2 diabetes will be randomized into either routine care with glycemic targets as currently recommended by ADA and ACOG (control arm), or more aggressive care with lower glycemic targets that more closely resemble normoglycemia in pregnancy (intervention arm). The glycemic targets for the control arm will be defined as follows: fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL. The glycemic targets for the intervention arm will be defined as follows: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL. The primary outcome will be a 250-gram difference in birth weight between the two study arms. Secondary maternal and neonatal outcomes of interest will also be compared between the two study arms.
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
- 是
入选标准
- •Pregnant women with a singleton gestation
- •18 years or older
- •Diagnosis of gestational diabetes (prior to 34 weeks gestational age) or Type 2 diabetes
排除标准
- •Diagnosed with gestational diabetes at or beyond 34 weeks gestational age
- •Type 1 diabetes
- •Diabetic retinopathy
- •Diabetic nephropathy
- •Diabetic vasculopathy
结局指标
主要结局
Difference in birth weight
时间窗: 41 weeks gestation
250-gram difference in birth weight
次要结局
- Total prenatal care visits(41 weeks gestation)
- Prenatal care visits after enrollment(41 weeks gestation)
- Prenatal care visits: log/glucometer(41 weeks gestation)
- Prenatal care visits: intervention(41 weeks gestation)
- Prenatal care visits: targets met(41 weeks gestation)
- Weekly target assessment(41 weeks gestation)
- Symptomatic hypoglycemia(41 weeks gestation)
- Asymptomatic hypoglycemia(41 weeks gestation)
- A1c enrollment(At time of enrollment (up to 34 weeks gestation))
- A1c 36 weeks(At 36 weeks gestational age)
- Lowest recorded blood sugar(41 weeks gestation)
- Highest recorded blood sugar(41 weeks gestation)
- Intrapartum insulin(From onset of induction/labor until delivery)
- Average recorded blood sugar(41 weeks gestation)
- Weekly compliance(41 weeks gestation)
- Diabetes medication(41 weeks gestation)
- Corticosteroids(41 weeks gestation)
- Oligohydramnios(41 weeks gestation)
- Induction of labor(During intrapartum admission to Labor & Delivery)
- Gestational weight gain(41 weeks gestation)
- Fetal growth restriction(41 weeks gestation)
- Antepartum admission(41 weeks gestation)
- Polyhydramnios(41 weeks gestation)
- Cesarean indication(During intrapartum admission to Labor & Delivery)
- TOLAC(During intrapartum admission to Labor & Delivery)
- Endometritis(Within 30 days postpartum)
- VTE(From conception until 30 days postpartum)
- Postpartum readmission(Within 30 days postpartum)
- 3rd or 4th degree laceration(During intrapartum admission to Labor & Delivery)
- Length of stay (maternal)(From admission to Labor & Delivery until discharge from postpartum)
- Cardiac complications(From conception until 30 days postpartum)
- Gestational age at delivery(During intrapartum admission to Labor & Delivery)
- Mode of delivery(During intrapartum admission to Labor & Delivery)
- Blood loss(During intrapartum admission to Labor & Delivery)
- PIH(From 20 weeks gestation until 30 days postpartum)
- Hypertensive emergency(From conception until 30 days postpartum)
- Postpartum wound complication(Within 30 days postpartum)
- Chorioamnionitis(During intrapartum admission to Labor & Delivery)
- Seizures(From conception until 30 days postpartum)
- Macrosomia(Within 24 hours of birth)
- SGA(Within 24 hours of birth)
- Apgar(5 minutes after birth)
- LGA(Within 24 hours of birth)
- Shoulder dystocia(During intrapartum admission to Labor & Delivery)
- Cord gas pH <7.0(Within 24 hours of birth)
- Base excess(Within 24 hours of birth)
- Neonatal blood glucose(Within 24 hours of birth)
- RDS(Within 30 days of delivery)
- TTN(Within 30 days of delivery)
- Hyperbilirubinemia(Within 30 days of delivery)
- Neonatal sepsis(Within 30 days of delivery)
- IUFD or stillbirth(From conception until delivery)
- NICU(Within 30 days of delivery)
- Length of stay (neonatal)(From birth until discharge (up to 1 year))
- Congenital anomaly(Within 30 days of delivery)
研究者
Brendan Grubbs
Assistant Professor
University of Southern California