Pregnancy Clinical Trial
Official title:
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
To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.
Status | Terminated |
Enrollment | 8 |
Est. completion date | April 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - pregnant women - 12-15weeks of pregnancy - obese (body mass index>30) Exclusion Criteria: - known sleep apnea syndrome - mental illness, deficiency |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | CHU St Pierre | Brussels |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | prevalence of sleep apnea syndrome (OSA) in obese pregnant women | Positive OSA on Watch Pat 200 must be confirmed by polysomnography | 1 month | No |
Secondary | composite score assessing pregnancy course and materno-foetal complications | 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 | 6 months | No |
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