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UnknownNCT01734460

Maternal Sleep Disordered Breathing and Fetal Growth

Status
Unknown
Phase
Study type
Observational
Enrollment
230 (estimated)
Sponsor
Tel-Aviv Sourasky Medical Center · Other Government
Sex
Female
Age
18 Years – 40 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Timeline

Start date
2013-01-01
Primary completion
2016-12-01
First posted
2012-11-27
Last updated
2012-11-27

Locations

2 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT01734460. Inclusion in this directory is not an endorsement.

Maternal Sleep Disordered Breathing and Fetal Growth (NCT01734460) · Clinical Trials Directory