This trial is active, not recruiting.

Condition respiratory disorder in patient with gestational diabetes
Treatment respiratory disorder assessment during sleep
Sponsor Assistance Publique Hopitaux De Marseille
Start date April 2016
End date April 2018
Trial size 40 participants
Trial identifier NCT02756442, 2015-41, 2015-A01796-43



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.


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model parallel assignment
Masking open label
Primary purpose prevention
respiratory disorder assessment during sleep
(Active Comparator)
respiratory disorder assessment during sleep

Primary Outcomes

Respiratory Disturbance Index
time frame: 4 month

Secondary Outcomes

Air flow debit associated to micro awaking during sleep
time frame: 4 month

Eligibility Criteria

Female participants at least 18 years old.

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

Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.