Sleep Apnea Syndrome in Obese Women During Pregnancy

Sponsor

University Hospital, Lille (Other)

Overall Status

Completed

CT.gov ID

NCT03509805

Collaborator

(none)

Enrollment

Location

Arms

78.4

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Apnea, Obstructive Sleep Pregnancy Complications Pre-Eclampsia Obesity	Diagnostic Test: polysomnography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

89 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Sleep Apnea Syndrome in Obese Women During Pregnancy

Actual Study Start Date :

Sep 1, 2010

Actual Primary Completion Date :

Mar 14, 2017

Actual Study Completion Date :

Mar 14, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OSA in obese patient during pregnancy OSA in polysomnography	Diagnostic Test: polysomnography
Experimental: no OSA in obese patient during pregnancy no OSA in polysomnography	Diagnostic Test: polysomnography

Arm

Intervention/Treatment

Experimental: OSA in obese patient during pregnancy

OSA in polysomnography

Diagnostic Test: polysomnography

Experimental: no OSA in obese patient during pregnancy

no OSA in polysomnography

Diagnostic Test: polysomnography

Outcome Measures

Primary Outcome Measures

Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria [during the sleep time, an average 8 hours]

Secondary Outcome Measures

occurrence of vascular disease [from inclusion at the beginning of the management of pregnancy to delivery]
High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia
Evaluation of fetal impact by correlation of birth weight to gestational age [from inclusion at the beginning of the management of pregnancy to delivery]