- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02756442
Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Marseille, France, 13354
- Assistance Publique Hopitaux de Marseille
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pregnant women with gestational diabetes
|
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Active Comparator: pregnant women without gestational diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Respiratory Disturbance Index
Time Frame: 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)
|
4 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Air flow debit associated to micro awaking during sleep
Time Frame: 4 month
|
To assess the resistance airways syndrome
|
4 month
|
Collaborators and Investigators
Investigators
- Study Director: Urielle DESALBRES, AP-HM
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-A01796-43
- 2015-41 (Other Identifier: AP-HM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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