NCT03080337终止不适用
Group Prenatal Care Compared to Traditional Prenatal Care for Women With Pre-gestational Diabetes: A Randomized Clinical Trial.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Compliance with glucose testing over time
研究概览
简要总结
This study aims to use an innovative and integrated educational curriculum to deliver prenatal care and diabetes care for pre-gestational diabetic women from approximately the first trimester of pregnancy through delivery and the early postpartum period in a group care model. The group care model will be compared to a control group, a traditional, individual care model.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinically confirmed viable pregnancy at the time of enrollment.
- •Able to provide consent for participation.
- •Diabetes diagnosed prior to 12 weeks gestation.
- •Initiation of care by 20 weeks gestation.
- •Age 18 years or older.
排除标准
- •Not planning to deliver at UnityPoint Health- Meriter Hospital.
结局指标
主要结局
Compliance with glucose testing over time
时间窗: 2 years
Compare the glucose compliance of participants in the group care model to the control group: a traditional, individual care model.
次要结局
- Blood Pressure (mm Hg)(2 years)
- Neonatal Length of stay (days)(2 years)
- Maternal Weight Gain (kilograms)(2 years)
- Neonatal Birth Weight (grams)(2 years)
- Gestational Age at Delivery (weeks)(2 years)
- Pregnancy related and Diabetes related knowledge acquired during pregnancy (survey)(2 years)
- Patient and care giver satisfaction (survey)(2 years)
- Length of stay for delivery (days)(2 years)
- Presence of infection (Y/N)(2 years)
- Type of Delivery (Vaginal, C-Section, Vacuum, Forceps, other)(2 years)
- Neonatal APGAR Score (0-10)(2 years)
- Cost-effectiveness (dollars per hour)(2 years)
研究者
研究点 (2)
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