Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese
Primary Purpose
Respiratory Disorder in Patient With Gestational Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Respiratory disorder assessment during sleep
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Disorder in Patient With Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Sites / Locations
- Assistance Publique Hopitaux de Marseille
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pregnant women with gestational diabetes
pregnant women without gestational diabetes
Arm Description
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Air flow debit associated to micro awaking during sleep
To assess the resistance airways syndrome
Full Information
NCT ID
NCT02756442
First Posted
April 27, 2016
Last Updated
April 27, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02756442
Brief Title
Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Disorder in Patient With Gestational Diabetes
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pregnant women with gestational diabetes
Arm Type
Experimental
Arm Title
pregnant women without gestational diabetes
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Respiratory disorder assessment during sleep
Primary Outcome Measure Information:
Title
Respiratory Disturbance Index
Description
Compare the respiratory disorder during sleep for pregnant women betwwen 2 groups with and without gestational diabetes based on RDI (Respiratory Disturbance Index)
Time Frame
4 month
Secondary Outcome Measure Information:
Title
Air flow debit associated to micro awaking during sleep
Description
To assess the resistance airways syndrome
Time Frame
4 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
AP-HM
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese
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