NCT03318003已完成不适用
Auto-PAP Therapy For Improved Fetal Growth
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester
研究概览
简要总结
The purpose of this study is to see whether the presence of night-time breathing disturbances ("sleep-disordered breathing") in pregnant women is related to fetal growth patterns. The hypothesis is that fetal growth slows in the 3rd trimester in women with sleep-disordered breathing. Use of a nighttime breathing therapy called auto-PAP could minimize the slowing in fetal growth.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old;
- •no more than 20 weeks pregnant;
- •pregnant with one baby;
- •found to have sleep-disordered breathing as measured by a sleep study. If you are found to have severe sleep apnea on the sleep study you will be referred for clinical care instead of participating in the study.
排除标准
- •more than 20 weeks pregnant;
- •pregnant with twins, triplets, or more babies;
- •a current smoker, drink alcohol, or use recreational drugs;
- •currently using positive-airway pressure therapy for treatment of obstructive sleep apnea;
- •diagnosed with certain conditions such as bullous lung disease, a bypassed upper airway, pneumothorax (collapsed lung), pneumocephalus (leak of cerebrospinal fluid, the fluid that the brain and spine float in), if you have had recent trauma, or recent nasal surgery.
结局指标
主要结局
Number of Participants With Slowing of Fetal Growth by 33% or More During the Last Trimester
时间窗: 3rd trimester
A slowing of fetal growth will be defined as a slowing of fetal growth by \>=33% during the last trimester
次要结局
- Presence or Absence of Placental Hypoxia(At delivery the placenta will be collected and processed.)
研究者
Louise O'Brien
Associate Professor
University of Michigan
研究点 (2)
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