NCT02029859
Completed
Not Applicable
Sleep Apnea, Obesity and Pregnancy
University Hospital, Rouen4 sites in 1 country205 target enrollmentApril 2011
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University Hospital, Rouen
- Enrollment
- 205
- Locations
- 4
- Primary Endpoint
- Sleep apnea syndrom prevalence
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
Main objective:
Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .
Secondary objectives :
- Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .
- Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.
- Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.
Material and methods
Characteristics of the study:
- Interventional biomedical research
- Prospective Multicenter nonrandomized study
Flow chart
- Patients will be included between 30 and 36 weeks of amenorrhea (WA) .
- Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.
- As recommended in France, the main test results during the pregnancy follow-up will be recorded.
- At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.
- Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.
- In case of proven OSA patients will be offered an appropriate care by today's standards.
- Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnancy after 30 Weeks of amenorhea
- •Age \> 18
- •Signed consentment
- •Nationnal Health Program affiliation
Exclusion Criteria
- •Twin or more pregnancy
- •Imprecise term
- •Artificial insemination with donor gametes
- •Proved thrombophilia
- •chronic renal failure
- •Previously treated (with CPAP) obstructive sleep apnea syndrom
Outcomes
Primary Outcomes
Sleep apnea syndrom prevalence
Time Frame: 6 weeks
Polygraphic examination for all subjects will determine the sleep apnea syndrom prevalence during late pregnancy (after 30 weeks of amenorhea) for severe obese women (BMI\>35).
Study Sites (4)
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