Sleep Apnea, Obesity and Pregnancy (GOS)
Primary Purpose
Obesity, Pregnancy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polygraphic examination
Sponsored by
About this trial
This is an interventional diagnostic trial for Obesity focused on measuring pregnancy (after 30 weeks of amenorhea), obesity (BMI>35), sleep apnea syndrom, preeclampsy, intrauterine growth restriction
Eligibility Criteria
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
Sites / Locations
- Angers University Hospital
- Caen University Hospital
- Le Havre Hospital
- Rouen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prevalence of obstructive sleep apnea syndrome
Arm Description
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
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02029859
First Posted
January 6, 2014
Last Updated
June 2, 2015
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT02029859
Brief Title
Sleep Apnea, Obesity and Pregnancy
Acronym
GOS
Official Title
Sleep Apnea, Obesity and Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Pregnancy
Keywords
pregnancy (after 30 weeks of amenorhea), obesity (BMI>35), sleep apnea syndrom, preeclampsy, intrauterine growth restriction
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prevalence of obstructive sleep apnea syndrome
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Polygraphic examination
Intervention Description
Polygraphic examination between 30 and 36 weeks of amenorhea
Primary Outcome Measure Information:
Title
Sleep apnea syndrom prevalence
Description
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).
Time Frame
6 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loic Marpeau, PHD
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angers University Hospital
City
Angers
ZIP/Postal Code
49000
Country
France
Facility Name
Caen University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Le Havre Hospital
City
Le Havre
ZIP/Postal Code
76290
Country
France
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Sleep Apnea, Obesity and Pregnancy
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