Sleep Apnea, Obesity and Pregnancy

Obesity Clinical Trial

— GOS  

Official title:

Sleep Apnea, Obesity and Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029859
• Other study ID #: 2009/070/HP
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: June 2, 2015
• Start date: April 2011
• Est. completion date: March 2015

Study information

• Verified date: June 2015
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: March 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Obesity
• Pregnancy

Intervention

Procedure:
• Polygraphic examination
Polygraphic examination between 30 and 36 weeks of amenorhea

Locations

Country	Name	City	State
France	Angers University Hospital	Angers
France	Caen University Hospital	Caen
France	Le Havre Hospital	Le Havre
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep apnea syndrom prevalence	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).	6 weeks	No