The Association Between High Risk Pregnancy and Sleep-disordered Breathing
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- apnea-hypopnea index
研究概览
简要总结
The aim of the present study is to establish, using polysomnographic criteria and prospective nature, whether sleep apnea in pregnancy is more prevalent in women with high risk pregnancies including preeclampsia, gestational diabetes, and pre-mature contractions, and to determine the effect of sleep disordered breathing in pregnancy on fetal outcome. The investigators' hypothesis is that sleep-disordered breathing is more prevalent in women with high risk pregnancy compared to those with uncomplicated pregnancy.
详细描述
Over the last decade, the association between sleep disordered breathing and pregnancy outcome has been described primarily in case reports. Although recently, larger studies describing adverse pregnancy outcomes in women with sleep disordered breathing has begun to emerge, these studies often lack polysomnographic data and the true prevalence of sleep disordered breathing in pregnancy is not known. We intend to recruit 100 women at the third trimester of pregnancy, who are admitted to the high risk pregnancy unit with pre-eclampsia, gestational diabetes, or premature labor. An additional group of 50 women at the third trimester of an uncomplicated pregnancy will be recruited. All women will fill questionnaires regarding the pregnancy and their sleep and will undergo an overnight sleep study. Women will then be followed until birth. Pregnancy complication, birth and perinatal course will be recorded. Cord blood will be collected from all infants and evaluated for inflammatory cytokines, reactive oxygen species and growth factors. Infants will then be followed for 1 year. Their growth, development and intercurrent illnesses will be recorded.
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
- 19 Years 至 39 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 19 - 39 years
- •Over 26 weeks of gestation
- •One of the following:
- •Pre-eclampsia defined as systolic blood pressure > 140 or diastolic blood pressure > 90 and associated proteinuria > 300 mg / 24 h urine collection.
- •Gestational diabetes requiring insulin treatment
- •Premature contractions with associated cervical dilation or effacement
- •Uncomplicated pregnancy
排除标准
- •Chronic maternal disease
- •Alcohol consumption during pregnancy
- •Illicit drug abuse at any time in life
- •Fetal abnormalities on obstetric ultrasound
结局指标
主要结局
apnea-hypopnea index
时间窗: At time of assessment
次要结局
- birth weight, apgar score(at birth)
- inflammatory markers in cord blood(at birth)
- growth and development during the 1st year of life(at age 1 year)
