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Clinical Trials/NCT01585844
NCT01585844
Completed
Not Applicable

Obstructive Sleep Apnea in Pregnancy:Epidemiology and Maternal/ Neonatal Morbidity

MetroHealth Medical Center1 site in 1 country182 target enrollmentAugust 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
MetroHealth Medical Center
Enrollment
182
Locations
1
Primary Endpoint
The prevalence of sleep apnea in obese pregnant women
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Obstructive sleep apnea is known to be a significant source of morbidity in the general population. It has been proposed to be associated with the development of preeclampsia and fetal growth restriction. As these are conditions that have long term maternal and neonatal implications, further information may help improve maternal/fetal outcome. One reason why women and in particular pregnant women are under diagnosed is the lack of an effective, reliable screening tool. Validated questionnaires used in the general population may not be effective in screening pregnant women. The investigators hypothesize that sleep apnea will have 20% prevalence in the obese pregnant population and that it is associated with increased maternal and neonatal morbidity. The investigators will recruit obese pregnant women in their prenatal care clinics and they will be screened for OSA using validated sleep questionnaires including the Epworth sleepiness scale, the Fatigue Scale and the Berlin Questionnaire. The subjects will then perform overnight apnea monitoring utilizing a portable sleep apnea detection device. Women who meet clinical criteria for OSA will be referred for overnight polysomnogram and management by the Pulmonary and Critical Care Division of the Internal Medicine Department. For all enrolled patients the remainder of prenatal care will be per routine. Data will be collected regarding the pregnancy course and outcomes.

The primary outcome of interest is the prevalence of sleep apnea in obese women and the associated maternal and neonatal morbidity. The secondary outcome measures will be molecular measures of systemic inflammation, oxidative stress and angiogenesis associated with sleep apnea.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
April 2012
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Prepregnancy BMI of 30kg/m2 or greater
  • Singleton pregnancy
  • 18 years or older

Exclusion Criteria

  • Chronic use of narcotics or other CNS drugs
  • Inability to sleep beyond 2 hours
  • 3 or more missed prenatal visits

Outcomes

Primary Outcomes

The prevalence of sleep apnea in obese pregnant women

Time Frame: Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks

Secondary Outcomes

  • The prevalence of maternal and neonatal morbidity(Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks)
  • Alterations in biomarkers of inflammation and oxidative stress(Subjects will be followed for the duration of their pregnancy and postpartum period, an expected average of 26 weeks)

Study Sites (1)

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