Respiratory Disorder During Sleep in the Pregnancy : A Risk Factor in Gestational Diabetese

NCT ID: NCT02756442

Last Updated: 2016-04-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-04-30

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.

Conditions

Respiratory Disorder in Patient With Gestational Diabetes

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

pregnant women with gestational diabetes

Group Type: EXPERIMENTAL

Respiratory disorder assessment during sleep

Intervention Type: OTHER

pregnant women without gestational diabetes

Group Type: ACTIVE_COMPARATOR

Respiratory disorder assessment during sleep

Intervention Type: OTHER

Interventions

Respiratory disorder assessment during sleep

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES

Role: STUDY_DIRECTOR

AP-HM

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2015-41

Identifier Type: OTHER

Identifier Source: secondary_id

2015-A01796-43

Identifier Type: -

Identifier Source: org_study_id