Sponsor study identifier
Secondary identifiers
OTHER · AP-HM
interventional
40
1 country
1
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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April 2016
Date type not reportedThis date has not been verified as actual or estimated.
April 27, 2016
Actual (reported)April 29, 2016
Actual (reported)April 2018
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Respiratory Disturbance Index
Compare the respiratory disorder during sleep for pregnant women betwwen 2 groups with and without gestational diabetes based on RDI (Respiratory Disturbance Index)
4 month
Air flow debit associated to micro awaking during sleep
4 month
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Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Urielle DESALBRES
AP-HM
First Submitted
April 27, 2016
First Posted
April 29, 2016
Study Start
April 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2018
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
April 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 29, 2016
Record last verified: 2016-04
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