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临床试验/NCT03509805
NCT03509805已完成不适用

Sleep Apnea Syndrome in Obese Women During Pregnancy

University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2010年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
89
试验地点
2
主要终点
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria

研究概览

简要总结

Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth.

The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy.

the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • age >18 years
  • BMI > 35
  • > 24th weeks of pregnancy
  • informed consent,
  • health assurance

排除标准

  • no informed consent
  • twin pregnancy or more
  • no health assurance

研究组 & 干预措施

OSA in obese patient during pregnancy

Experimental

OSA in polysomnography

干预措施: polysomnography (Diagnostic Test)

no OSA in obese patient during pregnancy

Experimental

no OSA in polysomnography

干预措施: polysomnography (Diagnostic Test)

结局指标

主要结局

Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria

时间窗: during the sleep time, an average 8 hours

次要结局

  • occurrence of vascular disease(from inclusion at the beginning of the management of pregnancy to delivery)
  • Evaluation of fetal impact by correlation of birth weight to gestational age(from inclusion at the beginning of the management of pregnancy to delivery)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (2)

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