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临床试验/NCT01022619
NCT01022619Unknown不适用

The Association Between High Risk Pregnancy and Sleep-disordered Breathing

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年1月最近更新:
适应症

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

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)

研究者

申办方类型
Other Gov

研究点 (2)

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