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Completed

NCT Number: NCT01585844

Sleep Apnea in Pregnancy Screening Study

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Alterations in biomarkers of inflammation and oxidative stress

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

  2. The prevalence of maternal and neonatal morbidity

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

Sponsors and collaborators

Lead sponsor

MetroHealth Medical Center

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Official study title

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

Acronym: SAPSS

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Apr 26, 2012
Registry last updated
Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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