Sleep Apnea, Obesity and Pregnancy

Study Overview
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Brief Summary
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Main objective: Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients . Secondary objectives : Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) . Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls. Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy. Material and methods Characteristics of the study: Interventional biomedical research Prospective Multicenter nonrandomized study Flow chart Patients will be included between 30 and 36 weeks of amenorrhea (WA) . Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure. As recommended in France, the main test results during the pregnancy follow-up will be recorded. At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score. Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient. In case of proven OSA patients will be offered an appropriate care by today's standards. Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.

Official Title
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Sleep Apnea, Obesity and Pregnancy

Conditions
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Obesity, Pregnancy

Intervention / Treatment
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* Procedure: Polygraphic examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >35 Pregnancy after 30 Weeks of amenorhea Age > 18 Signed consentment Nationnal Health Program affiliation Exclusion Criteria: Twin or more pregnancy Imprecise term Artificial insemination with donor gametes Proved thrombophilia chronic renal failure Previously treated (with CPAP) obstructive sleep apnea syndrom

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prevalence of obstructive sleep apnea syndrome<br>Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients . Polygraphic examination between 30 and 36 weeks of amenorhea | Procedure: Polygraphic examination<br>* Polygraphic examination between 30 and 36 weeks of amenorhea<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep apnea syndrom prevalence | Polygraphic examination for all subjects will determine the sleep apnea syndrom prevalence during late pregnancy (after 30 weeks of amenorhea) for severe obese women (BMI>35). | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy (after 30 weeks of amenorhea), obesity (BMI>35), sleep apnea syndrom, preeclampsy, intrauterine growth restriction