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Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Louise O'Brien, University of Michigan
ClinicalTrials.gov Identifier:
NCT01030003
First received: December 8, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Sleep Apnea Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Sleep-Disordered Breathing on Adverse Pregnancy Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Maternal diagnosis of hypertension [ Time Frame: 0-3 months after enrollment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Infant birth centile [ Time Frame: 0-3 months after enrollment. ] [ Designated as safety issue: No ]

Enrollment: 1685
Study Start Date: January 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01030003

Locations
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
Principal Investigator: Louise M O'Brien, PhD University of Michigan
  More Information

No publications provided

Responsible Party: Louise O'Brien, Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01030003     History of Changes
Other Study ID Numbers: R000038, 1R21HL089918-01A1
Study First Received: December 8, 2009
Last Updated: March 6, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Michigan:
Sleep-Disordered Breathing
Snoring
Pregnancy
Fetal Growth Retardation
Pre-Eclampsia

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

ClinicalTrials.gov processed this record on June 18, 2013