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Maternal Sleep Disordered Breathing and Fetal Growth

NCT ID: NCT01734460

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Disordered Breathing

Keywords

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pregnancy, snoring, fetal growth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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third trimester pregnant women

no intervention

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* low risk third trimester pregnant women

Exclusion Criteria

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

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Tel Aviv Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Central Contacts

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Riva Tauman, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Riva Tauman, MD

Role: primary

Riva Tauman, MD

Role: primary

Other Identifiers

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TASMC-12-RT-0510-12-TLV-CTIL

Identifier Type: -

Identifier Source: org_study_id