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临床试验/NCT02649933
NCT02649933终止不适用

Detection of Sleep Apnea Syndrome (OSA) With Watch PAT 200 in Pregnant Women and Assessment of Impact of OSA on Intra-uterine Fetal Growth and Maternal Well-being

Centre Hospitalier Universitaire Saint Pierre1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2015年11月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
8
试验地点
1
主要终点
prevalence of sleep apnea syndrome (OSA) in obese pregnant women

研究概览

简要总结

To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.

详细描述

During pregnancy, obstructive sleep apnea (OSA) prevalence is estimated between 5% and 15% and is associated with maternal and fetal comorbidities such as preeclampsia, neonatal intensive care admission , fetal growth retardation , preterm birth but even if growing, literature is still relatively poor about this topic.

To date, there is no systematic screening of OSA performed in at-risk pregnant women (obesity, hypertension, diabetes, fetal growth retardation, suggestive symptoms), probably mainly because of polysomnography complexity and accessibility.

As in non pregnant woman, OSA must be treated adequately during pregnancy. Continuous positive airway pressure (CPAP) is the reference treatment for severe OSA. This device, by blowing air under pressure in upper airways, via a nasal of an oro-nasal mask, is able to alleviate the upper airway collapse responsible for the occurrence of obstructive sleep apnea. It has been proven to offer a survival benefit in patients with severe disease and to improve sleep quality, cardiovascular variables and health-related quality of life . CPAP have been shown to improve fetal well-being in pre-eclampsia .

Oral appliance can be an alternative for mild to moderate disease and in patients who do not tolerate CPAP. Positional counselling can be sufficient in case of mild to moderate positional OSA. Associated behavioural strategies (diet and exercise) are always recommended in case of excessive weight. Surgical treatments are dedicated to patients with specific anatomic problems but cannot be performed during pregancy.

Aim of the study:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women
  • 12-15weeks of pregnancy
  • obese (body mass index>30)

排除标准

  • known sleep apnea syndrome
  • mental illness, deficiency

结局指标

主要结局

prevalence of sleep apnea syndrome (OSA) in obese pregnant women

时间窗: 1 month

Positive OSA on Watch Pat 200 must be confirmed by polysomnography

次要结局

  • composite score assessing pregnancy course and materno-foetal complications(6 months)

研究者

发起方
Centre Hospitalier Universitaire Saint Pierre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marie Bruyneel

chef de clinique service de pneumologie

Centre Hospitalier Universitaire Saint Pierre

研究点 (1)

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