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
- 否
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
研究点 (8)
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