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临床试验/NCT01585844
NCT01585844已完成不适用

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

MetroHealth Medical Center1 个研究点 分布在 1 个国家目标入组 182 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
182
试验地点
1
主要终点
The prevalence of sleep apnea in obese pregnant women

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

The prevalence of sleep apnea in obese pregnant women

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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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