Gestation Diabetes N'Teractive Media-based Education (GDnME) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 2
- 主要终点
- Total number of women who failed management with diet alone
研究概览
简要总结
This study is a prospective randomized controlled trial. Subjects with newly diagnosed gestational diabetes will be randomized to either standard of care diabetes education versus standard of care plus an interactive educational application.
详细描述
Gestational diabetes is a condition diagnosed during pregnancy that causes blood sugars to rise. Diet and exercise can effectively control blood sugar levels in 70-85% of women diagnosed with gestational diabetes according to the American Diabetes Association. At the investigator's institution, only 50-54% of women with this diagnosis effectively reach the target blood sugar levels with diet and exercise alone. This has become a more commonly seen problem throughout the US. Those that fail to achieve target blood sugar levels require medication and have higher risks of poor maternal and neonatal outcomes. Studies have shown that an increase in education can increase compliance to diet and education. Specifically, media based education that are interactive may more effectively lead to changes in a person's behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Obtaining prenatal care in the Ambulatory Care Network (ACN)
- •Speaks either English or Spanish
- •Newly diagnosed with gestational diabetes between 24-32 weeks
- •Will deliver at CUIMC's main institutions, Children's Hospital of New York (CHONY) or the Allen Hospital.
排除标准
- •Diagnosed with a fetal anomaly
- •Have multiple gestation
- •Known diagnosis of pregestational diabetes
结局指标
主要结局
Total number of women who failed management with diet alone
时间窗: Up to 42 weeks
This is defined as a patient who is unable to adequately control blood sugars with diet alone and requires medical intervention. This information will be collected until the time of delivery which could be up to 42 weeks of gestation.
次要结局
- Total insulin requirement(Up to 42 weeks)
- Total number of women who develop gestational hypertension(Up to 42 weeks)
- Total number of women who develop pre-eclampsia(Up to 42 weeks)
- Total number of neonates with neonatal hypoglycemia(Up to postpartum day 7)
- Total number of neonates with jaundice(Up to postpartum day 7)
- Average fasting blood sugar level(Up to 42 weeks)
- Difference in weight(Up to 42 weeks)
- Total number of neonates with neonatal respiratory distress syndrome(Up to postpartum day 7)
- Average 2 hour post-prandial blood sugar level(Up to 42 weeks)
- Total metformin requirement(Up to 42 weeks)
- C-section rate(Up to 42 weeks)
- Total number of neonates with shoulder dystocia(Up to 42 weeks)
- Total number of neonates with a NICU admission(Up to postpartum day 7)
- A1C Level(Up to 42 weeks)
- Total number of neonates with an Apgar score <7(Up to 42 weeks)
- Total number of neonates with a preterm birth(Up to 36 weeks and 6 days of gestation)