Respiratory Disorder in Patient With Gestational Diabetes Clinical Trial
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.
| Status | Active, not recruiting |
| Enrollment | 40 |
| Est. completion date | April 2019 |
| Est. primary completion date | April 2018 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hopitaux de Marseille | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Air flow debit associated to micro awaking during sleep | To assess the resistance airways syndrome | 4 month | No |