Maternal Sleep Disordered Breathing and Fetal Growth
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Purpose
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.
| Condition |
|---|
|
Sleep Disordered Breathing |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
- birth weight [ Time Frame: at birth ] [ Designated as safety issue: No ]
- birth length [ Time Frame: at birth ] [ Designated as safety issue: No ]
- birth head circumference [ Time Frame: at birth ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 230 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
third trimester pregnant women
no intervention
|
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
women health care centers
Inclusion Criteria:
- low risk third trimester pregnant women
Exclusion Criteria:
- pregnancy complications (preeclampsia, HTN, GDM),
- any chronic medical condition.
Contacts and Locations| Contact: Riva Tauman, MD | tauman@tlvmc.gov.il |
| Israel | |
| Tel Aviv Medical Center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Riva Tauman, MD tauman@tlvmc.gov.il | |
| Principal Investigator: Riva Tauman, MD | |
| Tel Aviv Medical Center | Not yet recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Riva Tauman, MD tauman@tlvmc.gov.il | |
More Information
No publications provided
| Responsible Party: | Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01734460 History of Changes |
| Other Study ID Numbers: | TASMC-12-RT-0510-12-TLV-CTIL |
| Study First Received: | November 21, 2012 |
| Last Updated: | November 26, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
pregnancy, snoring, fetal growth |
Additional relevant MeSH terms:
|
Respiratory Aspiration Sleep Apnea Syndromes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms |
Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013