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

NCT ID: NCT02649933

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-04-30

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.

Conditions

Pregnancy; Sleep Apnea Syndrome; Obstructive Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Watch PAt 200

obese pregnant women, pregnancy between 12 and 15 weeks

Watch PAT 200

Intervention Type: DEVICE

screening of OSA with Watch PAT 200

Interventions

Watch PAT 200

screening of OSA with Watch PAT 200

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• known sleep apnea syndrome
• mental illness, deficiency

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Saint Pierre

OTHER

Sponsor Role: lead

Responsible Party

Marie Bruyneel

chef de clinique service de pneumologie

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHU St Pierre

Brussels, , Belgium

Countries

Belgium

Other Identifiers

AK/14-11-105/4434

Identifier Type: -

Identifier Source: org_study_id