Clinical trial NCT01734460: Maternal Sleep Disordered Breathing and Fetal Growth
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Disordered Breathing
Keywords: pregnancy, snoring, fetal growth
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-11-27
Enrollment: 230
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women health care centers

Brief 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.


Eligibility criteria: Inclusion Criteria:

* low risk third trimester pregnant women

Exclusion Criteria:

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

Primary outcomes:
measure: birth weight
timeFrame: at birth
Secondary outcomes:
measure: birth length
timeFrame: at birth
Other outcomes:
measure: birth head circumference
timeFrame: at birth
Locations:
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Medical Center
Study officials:
References: