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临床试验/NCT01734460
NCT01734460Unknown不适用

Maternal Sleep Disordered Breathing and Fetal Growth

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 230 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
230
试验地点
1
主要终点
birth weight

研究概览

简要总结

Sleep disordered breathing (SDB) is a common condition affecting up to 9% of adults with serious neurocognitive, metabolic and cardiovascular consequences that has a significant impact on public health. Evidence indicates that the physiologic changes occurring during pregnancy, particularly during the third trimester, increase the risk of those women to develop SDB. As in the general population, SDB during pregnancy is more frequent among obese women. In the light of the increasing prevalence of obesity among females of reproductive age, SDB may thus have an increasingly significant impact on women's and children's health by contributing to the adverse maternal and fetal outcomes associated with maternal obesity.

Only a limited amount of data is available on the consequences of maternal SDB during pregnancy. Even less information is available on the effect of maternal SDB on fetal growth and development. The current proposal is designed to specifically explore the effect of maternal SDB on fetal growth.

It has been suggested that fetal growth as reflected in birth weight is a strong correlate for conditions occurring in the intrauterine environment with potential long lasting influence on a child's health.

Our overall hypothesis is that the intermittent hypoxia, sleep fragmentation and the metabolic alterations associated with maternal SDB will affect fetal growth.

Using a variety of methods and a multidisciplinary approach, we will explore the following objectives: 1) The effect of maternal SDB on fetal growth ; 2) To explore mechanisms that may underlay the effect of maternal SDB on fetal growth 3) To explore the long term (first 3 years of life) effect of maternal SDB on a child's growth.

The results of this study will make an important contribution to the fields of women and children's health. It will provide better insight into the mechanisms by which disrupted maternal sleep affects fetal growth.

We expect that the findings from our study will enable the defining of a new treatable clinical entity or syndrome: "the infant of the gestational SDB mother", for which early diagnosis and intervention might be of major importance to the newborn infant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • low risk third trimester pregnant women

排除标准

  • pregnancy complications (preeclampsia, HTN, GDM),
  • any chronic medical condition.

结局指标

主要结局

birth weight

时间窗: at birth

次要结局

  • birth length(at birth)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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