Sleep Intervention to Improve Glycemic Control in Women With Gestational Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Glycemic control
研究概览
简要总结
This is a pilot randomized controlled trial involving a sleep education intervention in women with gestational diabetes to study whether sleep education during pregnancy leads to improvement in glycemic control in women with gestational diabetes and improvement in sleep duration.
详细描述
Patients will be identified from the Maternal-Fetal Medicine office and the Perinatal Assessment Clinic at Magee-Womens Hospital, University of Pittsburgh Medical Center. Patients with gestational diabetes will be recruited following general education regarding gestational diabetes in pregnancy which is universally done for all patients at the time of their diagnosis of gestational diabetes. Eligible subjects will be randomized to two groups (usual care vs. sleep education program).
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant female
- •Gestational age between 16 0/7 weeks and 31 6/7 weeks
- •New diagnosis of GDM, not on treatment (i.e., insulin, glyburide, or metformin) at the time of enrollment
排除标准
- •Children less than 18 years of age
- •Non-English speaking
- •Multiple gestations (twins, triplets, etc)
结局指标
主要结局
Glycemic control
时间窗: 3-6 months during pregnancy
Proportion of participants achieving glycemic control at study end. Glycemic control defined as greater than 75% of weeks with average fasting blood glucose \< 95 mg/dL and 1-hr postprandial blood glucose \<140 mg/dL.
Self-reported sleep duration
时间窗: 3-6 months during pregnancy
Proportion of patients who report sleeping between 7-9 hours per night
次要结局
- Average fasting glucose values(3-6 months during pregnancy)
- Average postprandial glucose values(3-6 months during pregnancy)
- Gestational age at delivery(Time of delivery)
- Indication for delivery(Time of delivery)
- Neonatal birth weight(Time of delivery)
- Route of delivery(Time of delivery)
- Preeclampsia(Time of delivery)
研究者
Roxanna Twedt
Graduate Medical Fellow
University of Pittsburgh