Ignite Creation Date:
2024-05-06 @ 8:32 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02756442
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2016-04-27
Brief Title:
Respiratory Disorder During Sleep in the Pregnancy A Risk Factor in Gestational Diabetese
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-41 | OTHER | AP-HM | None |