Sleep Apnea, Obesity and Pregnancy

Not Applicable

Completed

• Conditions: Obesity; Pregnancy
• Interventions: Procedure: Polygraphic examination

• Registration Number: NCT02029859
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-01-06
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-08
• Primary Completion: 2014-07
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-02
• Last Update Posted: 2015-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

Inclusion Criteria

• BMI >35
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevalence of obstructive sleep apnea syndrome	Polygraphic examination	Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients . Polygraphic examination between 30 and 36 weeks of amenorhea

Primary Outcome Measures

Name	Time	Method
Sleep apnea syndrom prevalence	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).

Trial Locations

Locations (4)

Angers University Hospital; 🇫🇷 Angers, France

Le Havre Hospital; 🇫🇷 Le Havre, France

Rouen University Hospital; 🇫🇷 Rouen, France

Caen University Hospital; 🇫🇷 Caen, France