NCT02029859

Sleep Apnea, Obesity and Pregnancy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Pregnancy

Interventions

Type	Name	Description
PROCEDURE	Polygraphic examination	Polygraphic examination between 30 and 36 weeks of amenorhea

Timeline

• Start date: 2011-04-01
• Primary completion: 2014-07-01
• Completion: 2015-03-01
• First posted: 2014-01-08
• Last updated: 2015-06-03

Locations

4 sites across 1 country: France