Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes

This study has been completed.
Sponsor:
Collaborator:
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of Michigan

Additional 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
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
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014