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Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01030003
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : March 7, 2012
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan

Study Description
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Brief Summary:
The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby.

Condition or disease
Sleep Apnea Syndromes

Study Design
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Study Type : Observational
Actual Enrollment : 1685 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Sleep-Disordered Breathing on Adverse Pregnancy Outcomes
Study Start Date : January 2007
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Maternal diagnosis of hypertension [ Time Frame: 0-3 months after enrollment. ]

Secondary Outcome Measures :
  1. Infant birth centile [ Time Frame: 0-3 months after enrollment. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Eligible pregnant women are those receiving prenatal care and planning on delivering at the University of Michigan.
Criteria

Inclusion Criteria:

  • Women attending obstetric clinics at University of Michigan Hospitals.
  • Willing and able to provide informed consent.
  • Aged 18 years or older

Exclusion Criteria:

  • Aged under 18 years
Contacts and Locations
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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): NCT01030003


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Louise M O'Brien, PhD University of Michigan
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Louise O'Brien, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01030003    
Other Study ID Numbers: R000038
1R21HL089918-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: March 7, 2012
Last Verified: March 2012
Keywords provided by Louise O'Brien, University of Michigan:
Sleep-Disordered Breathing
Snoring
Pregnancy
Fetal Growth Retardation
Pre-Eclampsia
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases