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

Terminated

• Conditions: Sleep Apnea Syndrome; Pregnancy; Obstructive Sleep Apnea
• Interventions: Device: Watch PAT 200

• Registration Number: NCT02649933
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief 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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2016-01-06
• Study First Posted: 2016-01-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 8

Inclusion Criteria

• pregnant women
• 12-15weeks of pregnancy
• obese (body mass index>30)

Exclusion Criteria

• known sleep apnea syndrome
• mental illness, deficiency

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Watch PAt 200	Watch PAT 200	obese pregnant women, pregnancy between 12 and 15 weeks

Primary Outcome Measures

Name	Time	Method
prevalence of sleep apnea syndrome (OSA) in obese pregnant women	1 month	Positive OSA on Watch Pat 200 must be confirmed by polysomnography

Secondary Outcome Measures

Name	Time	Method
composite score assessing pregnancy course and materno-foetal complications	6 months	assessment of one composite score componed by on several parameters including Apgar Score,fœtal anoxia, intra-uterine growth retardation, low birth weight, prematurity, placental abruption,preeclamspia, foetal death In Utero

Trial Locations

Locations (1)

CHU St Pierre; 🇧🇪 Brussels, Belgium