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临床试验/NCT02756442
NCT02756442Unknown不适用

Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Respiratory Disturbance Index

研究概览

简要总结

Introduction:

The pregnancy brings about physiological and hormonal modifications which cause sleep disorder. The sleeplessness, snoring and a bad sleepquality are frequent during the pregnancy. Also a limited breathing airflow happens very often during the pregnancy. The limited airflow causes micro-awakenings that enter in the frame of the high resistances airways syndrome. To our knowledge there is no study about the outcome of micro-awakenings at pregnant women.

Objectives:

To compare the prevalence of the high resistances airways syndrome (RERA) in pregnant woman with or without gestational diabetes

Methods :

It is a monocentrical prospective study at pregnant women after the 30th amenorrhea week who consul the gynecologie and obstetrics department of the CHU NORD in Marseille. We are going to compare the breathing disorder during sleep of a control group with a group of women with gestational diabetes. A polysomnograph will be run at the included patients' home.

Expected results :

The physiological and hormonal modifications during the pregnancy could favor nocturnal sleep events (snoring, SAHOS and RERA) and its complications as gravidic HPN And gestational diabetes cause maternal and fœtal and morbidity and mortality. We put the hypothesis that limited airflow in association with micro-awakenings in the RERA have a negative impact on the glucose metabolism and favor the gestational diabetes.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Prevention
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

  • Pregnant woman in the 3rd quarter of pregnancy (24 to 32 weeks amennorhea).
  • Presenting a gestational diabetes ou not (=controle group)
  • Written and signed consent.

排除标准

  • Twin pregnancy
  • High blood pressure before pregnancy
  • Diabetes diagnosed before pregnancy
  • Left ventricular ejection fraction below 40%
  • Alcohol consumption (more than 7 glaces/day), drugs of type hypnotic, sedative, opioids
  • History of gestational diabetes or glucose intolerance
  • Severe cronical respiratory impairment (severe asthma)
  • Creatinine clairance below 60 mL/min

结局指标

主要结局

Respiratory Disturbance Index

时间窗: 4 month

Compare the respiratory disorder during sleep for pregnant women betwwen 2 groups with and without gestational diabetes based on RDI (Respiratory Disturbance Index)

次要结局

  • Air flow debit associated to micro awaking during sleep(4 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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