NCT01030003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,685

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

4.6 years

First QC Date

December 8, 2009

Last Update Submit

March 6, 2012

Conditions

Sleep Apnea Syndromes

Keywords

Sleep-Disordered BreathingSnoringPregnancyFetal Growth RetardationPre-Eclampsia

Outcome Measures

Primary Outcomes (1)

  • Maternal diagnosis of hypertension

    0-3 months after enrollment.

Secondary Outcomes (1)

  • Infant birth centile

    0-3 months after enrollment.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible pregnant women are those receiving prenatal care and planning on delivering at the University of Michigan.

You may qualify if:

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

You may not qualify if:

  • Aged under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • O'Brien LM, Bullough AS, Owusu JT, Tremblay KA, Brincat CA, Chames MC, Kalbfleisch JD, Chervin RD. Snoring during pregnancy and delivery outcomes: a cohort study. Sleep. 2013 Nov 1;36(11):1625-32. doi: 10.5665/sleep.3112.

    PMID: 24179294DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesSnoringFetal Growth RetardationPre-Eclampsia

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesHypertension, Pregnancy-Induced

Study Officials

  • Louise M O'Brien, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 10, 2009

Study Start

January 1, 2007

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

US(1)