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临床试验/NCT02029859
NCT02029859已完成不适用

Sleep Apnea, Obesity and Pregnancy

University Hospital, Rouen8 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2011年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
205
试验地点
8
主要终点
Sleep apnea syndrom prevalence

研究概览

简要总结

Main objective:

Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .

Secondary objectives :

  • Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
  • Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
  • Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.

Material and methods

Characteristics of the study:

  • Interventional biomedical research
  • Prospective Multicenter nonrandomized study

Flow chart

  • Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
  • Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
  • As recommended in France, the main test results during the pregnancy follow-up will be recorded.
  • At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
  • Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
  • In case of proven OSA patients will be offered an appropriate care by today's standards.
  • Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
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

  • Pregnancy after 30 Weeks of amenorhea
  • Age > 18
  • Signed consentment
  • Nationnal Health Program affiliation

排除标准

  • Twin or more pregnancy
  • Imprecise term
  • Artificial insemination with donor gametes
  • Proved thrombophilia
  • chronic renal failure
  • Previously treated (with CPAP) obstructive sleep apnea syndrom

结局指标

主要结局

Sleep apnea syndrom prevalence

时间窗: 6 weeks

Polygraphic examination for all subjects will determine the sleep apnea syndrom prevalence during late pregnancy (after 30 weeks of amenorhea) for severe obese women (BMI\>35).

次要结局

未报告次要终点

研究者

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

研究点 (8)

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