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Maternal Sleep Disordered Breathing and Fetal Growth

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ClinicalTrials.gov Identifier: NCT01734460
Recruitment Status : Unknown
Verified August 2012 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 27, 2012
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Sleep Disordered Breathing

Study Design

Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Estimated Primary Completion Date : December 2016
Groups and Cohorts

Group/Cohort
third trimester pregnant women
no intervention


Outcome Measures

Primary Outcome Measures :
  1. birth weight [ Time Frame: at birth ]

Secondary Outcome Measures :
  1. birth length [ Time Frame: at birth ]

Other Outcome Measures:
  1. birth head circumference [ Time Frame: at birth ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
women health care centers
Criteria

Inclusion Criteria:

  • low risk third trimester pregnant women

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01734460


Contacts
Contact: Riva Tauman, MD tauman@tlvmc.gov.il

Locations
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   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
More Information

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
First Posted: November 27, 2012    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: August 2012

Keywords provided by Tel-Aviv Sourasky Medical Center:
pregnancy, snoring, fetal growth

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes