Maternal Sleep Disordered Breathing and Fetal Growth

NCT01734460 | Unknown

• 1 other identifier: TASMC-12-RT-0510-12-TLV-CTIL
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep Disordered Breathing

Keywords

pregnancy, snoring, fetal growth

Outcome Measures

Primary Outcomes (1)

• birth weight

  at birth

Secondary Outcomes (1)

• birth length

  at birth

Other Outcomes (1)

• birth head circumference

  at birth

Study Arms (1)

third trimester pregnant women

no intervention

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

women health care centers

You may qualify if:

• low risk third trimester pregnant women

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (2)

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Snoring

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Riva Tauman, MD

CONTACT

tauman@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2012
• First Posted: November 27, 2012
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Last Updated: November 27, 2012

Record last verified: 2012-08

Locations

IL (2)