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Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes

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ClinicalTrials.gov Identifier: NCT01030003
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : March 7, 2012
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan

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 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
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.

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

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

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)
Principal Investigator: Louise M O'Brien, PhD University of Michigan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Louise O'Brien, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01030003     History of Changes
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
Fetal Growth Retardation

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases