Sleep Apnea Syndrome in Obese Women During Pregnancy

Study Overview
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Brief Summary
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Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth. The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy. the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.

Official Title
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Sleep Apnea Syndrome in Obese Women During Pregnancy

Conditions
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Apnea, Obstructive Sleep, Pregnancy Complications, Pre-Eclampsia, Obesity

Intervention / Treatment
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* Diagnostic Test: polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age >18 years BMI > 35 > 24th weeks of pregnancy informed consent, health assurance Exclusion Criteria: no informed consent twin pregnancy or more no health assurance

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSA in obese patient during pregnancy<br>OSA in polysomnography | Diagnostic Test: polysomnography<br> <br> |
| Experimental: no OSA in obese patient during pregnancy<br>no OSA in polysomnography | Diagnostic Test: polysomnography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria |  | during the sleep time, an average 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of vascular disease | High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia | from inclusion at the beginning of the management of pregnancy to delivery | 
| Evaluation of fetal impact by correlation of birth weight to gestational age |  | from inclusion at the beginning of the management of pregnancy to delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sleep apnea syndrome, obesity, pregnancy, preeclampsia