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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02649933
Enrollment
8
Registered
2016-01-08
Start date
2015-11-30
Completion date
2016-04-30
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Pregnancy, Sleep Apnea Syndrome

Keywords

pregnancy, obstructive sleep apnea

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.

Interventions

DEVICEWatch PAT 200

screening of OSA with Watch PAT 200

Sponsors

Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* known sleep apnea syndrome * mental illness, deficiency

Design outcomes

Primary

MeasureTime frameDescription
prevalence of sleep apnea syndrome (OSA) in obese pregnant women1 monthPositive OSA on Watch Pat 200 must be confirmed by polysomnography

Secondary

MeasureTime frameDescription
composite score assessing pregnancy course and materno-foetal complications6 monthsassessment 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

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026