Improving Outcomes in Underserved Women With GDM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- maternal blood glucose control
研究概览
简要总结
Our objective is to test an innovative approach to improve outcomes among underserved women with gestational diabetes. We ill utilize a multi-lingual, Interactive Voice Response (IVR) -enabled telephone system to facilitate diabetes control and thereby improve pregnancy outcomes. Our hypothesis is that Telemonitoring will improve maternal glycemia, thereby reducing infant birth weights and leading to improved pregnancy outcomes.
详细描述
Using a step care design, women will be randomized into standard of care or Telemonitoring. In the standard of care group, women will monitor their blood glucose levels four times a day, perform fetal movement counting three times a day and also record insulin doses. The women will record this information in a logbook, which will be reviewed by the medical team at prenatal visits. In the Telemonitoring group, women will receive the standard of care anmd will also transmit their blood glucose and fetal movement information to their health care providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •diagnosis of GDM
- •33 or less weeks gestation
排除标准
- •multiple gestations
- •history of glucose intolerance outside of pregnancy
研究组 & 干预措施
1 Telemedicine
Usual care plus telemonitoring
干预措施: telemonitoring (Other)
2 Standard of Care
Standard of care - women will monitor and record blood glucose levels four times a day.
干预措施: Standard of care (Other)
结局指标
主要结局
maternal blood glucose control
时间窗: 3 to 9 months
次要结局
- infant birthweight(at delivery)