Sleep Apnea Syndrome in Obese Women During Pregnancy

Not Applicable

Completed

• Conditions: Apnea, Obstructive Sleep; Pre-Eclampsia; Obesity; Pregnancy Complications
• Interventions: Diagnostic Test: polysomnography

• Registration Number: NCT03509805
• Lead Sponsor: University Hospital, Lille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-01
• Primary Completion: 2017-03-14
• Study Completion: 2017-03-14
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-04-25
• Study First Posted: 2018-04-26
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-12
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA in obese patient during pregnancy	polysomnography	OSA in polysomnography
no OSA in obese patient during pregnancy	polysomnography	no OSA in polysomnography

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHRU,Hôpital Jeanne de Flandre; 🇫🇷 Lille, North, France