Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-27 @ 6:17 AM
Study NCT ID:
NCT02029859
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnea, Obesity and Pregnancy
Sponsor:
University Hospital, Rouen
Organization:
Study Overview
Official Title:
Sleep Apnea, Obesity and Pregnancy
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOS
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: