NCT02649933

Detection of Sleep Apnea Syndrome (OSA) in Pregnant Women and Assessment of Impact of OSA on Pregnancy Course

Detection of Sleep Apnea Syndrome (OSA) With Watch PAT 200 in Pregnant Women and Assessment of Impact of OSA on Intra-uterine Fetal Growth and Maternal Well-being

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Centre Hospitalier Universitaire Saint Pierre · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.

Detailed description

During pregnancy, obstructive sleep apnea (OSA) prevalence is estimated between 5% and 15% and is associated with maternal and fetal comorbidities such as preeclampsia, neonatal intensive care admission , fetal growth retardation , preterm birth but even if growing, literature is still relatively poor about this topic. To date, there is no systematic screening of OSA performed in at-risk pregnant women (obesity, hypertension, diabetes, fetal growth retardation, suggestive symptoms), probably mainly because of polysomnography complexity and accessibility. As in non pregnant woman, OSA must be treated adequately during pregnancy. Continuous positive airway pressure (CPAP) is the reference treatment for severe OSA. This device, by blowing air under pressure in upper airways, via a nasal of an oro-nasal mask, is able to alleviate the upper airway collapse responsible for the occurrence of obstructive sleep apnea. It has been proven to offer a survival benefit in patients with severe disease and to improve sleep quality, cardiovascular variables and health-related quality of life . CPAP have been shown to improve fetal well-being in pre-eclampsia . Oral appliance can be an alternative for mild to moderate disease and in patients who do not tolerate CPAP. Positional counselling can be sufficient in case of mild to moderate positional OSA. Associated behavioural strategies (diet and exercise) are always recommended in case of excessive weight. Surgical treatments are dedicated to patients with specific anatomic problems but cannot be performed during pregancy. Aim of the study: The primary aim of this study is to screen OSA in at risk pregnant women with Watch-PAT 200, a simplified sleep study tool used on ambulatory mode and able to detect accurately OSA in suspected patients. As secondary aim, we will observe the impact of OSA on a composite endpoint assessing materno-fetal wellbeing.

Conditions

• Pregnancy
• Sleep Apnea Syndrome
• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Watch PAT 200	screening of OSA with Watch PAT 200

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-01-08
• Last updated: 2016-05-13

Locations

1 site across 1 country: Belgium