Gestational Diabetes Mellitus: Does Early Screening and Treatment for Patients at Increased Risk for Gestational Diabetes Impact Perinatal Outcomes? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,020
- 试验地点
- 4
- 主要终点
- Composite Perinatal morbidity
研究概览
简要总结
In the current study we aim to determine if early glucose screening and treatment among women at high risk for GDM improves perinatal outcome and decreases gestational weight gain. Half of the participant will be assigned to an early glucose screen group (12-18 weeks) and treatment if necessary and the other half to a standard 24-28 weeks glucose screen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant subjects 18-45 y/o and Any of the following:
- •Obesity defined as having a BMI>30 kg/m2 History of pregnancy complicated with GDM History of pregnancy complicated with macrosomia First degree relative with diabetes Multiple gestation
排除标准
- •Incomplete Data: if any data is missing (i.e Delivery data) , analysis cannot be completed.
- •Pregnancy complicated with fetal malformations or aneuploidy: It affects prenatal care, mode of delivery as well as perinatal outcome.
- •Pregestational or Overt Diabetes: Patients with Diabetes cannot be diagnosed with GDM.
- •Chronic medical conditions such as hypertension, renal disease, autoimmune conditions: Those conditions may affect prenatal care, perinatal morbidity.
- •Early diabetes screen performed prior to enrollment in study: Participant cannot be randomized, and probably have been treated.
- •Medical contraindication to glucose tolerance test (bariatric surgery): patients with h/o gastric bypass frequently cannot tolerate oral glucose load, therefore cannot be screened for GDM in the traditional way.
结局指标
主要结局
Composite Perinatal morbidity
时间窗: up to 28 days after birth
The primary study outcome is a composite of perinatal morbidities including perinatal mortality (stillbirth or neonatal death), neonatal hypoglycemia, hyperbilirubinemia, and birth trauma. Transcutaneous bilirubin is routinely measured at Tampa General Hospital (TGH) on all babies at least once. A value greater than the 95th percentile for or need for phototherapy at any given point after birth will be considered an elevated level. Birth trauma is defined as brachial plexus palsy or clavicular, humeral, or skull fracture.
次要结局
- Maternal weight gain(up to delivery)