Sleep Apnea, Obesity and Pregnancy — GOS  

Obesity Clinical Trial

Official title: Sleep Apnea, Obesity and Pregnancy

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obesity
• Pregnancy

• NCT number: NCT02029859
• Study type: Interventional
• Source: University Hospital, Rouen
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Completion date: March 2015