Sleep Apnea Syndrome in Obese Women During Pregnancy
Primary Purpose
Apnea, Obstructive Sleep, Pregnancy Complications, Pre-Eclampsia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
polysomnography
Sponsored by
About this trial
This is an interventional supportive care trial for Apnea, Obstructive Sleep focused on measuring sleep apnea syndrome, obesity, pregnancy, preeclampsia
Eligibility Criteria
Inclusion Criteria:
- age >18 years
- BMI > 35
- > 24th weeks of pregnancy
- informed consent,
- health assurance
Exclusion Criteria:
- no informed consent
- twin pregnancy or more
- no health assurance
Sites / Locations
- CHRU,Hôpital Jeanne de Flandre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
OSA in obese patient during pregnancy
no OSA in obese patient during pregnancy
Arm Description
OSA in polysomnography
no OSA in polysomnography
Outcomes
Primary Outcome Measures
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria
Secondary Outcome Measures
occurrence of vascular disease
High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia
Evaluation of fetal impact by correlation of birth weight to gestational age
Full Information
NCT ID
NCT03509805
First Posted
April 24, 2018
Last Updated
October 12, 2018
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT03509805
Brief Title
Sleep Apnea Syndrome in Obese Women During Pregnancy
Official Title
Sleep Apnea Syndrome in Obese Women During Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 1, 2010 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Excess weight or obesity is associated with an increased risk of health disorders: high blood pressure, diabetes, cardiovascular risks, dyslipidemia and sleep apneas. During pregnancy in obese women, the risk of preeclampsia increases by three and the risk of fetal death in utero by five. Snoring and Obstructive sleep apnea (OSA) may be associated with increased risk of adverse pregnancy outcomes, including maternal cardio pulmonary status, fetal heart rate and fetal acidosis-basis status by recurrent upper-airway obstruction, hypoventilation, and intermittent nocturnal hypoxia. Reports in pregnancy have identified in association with OSA and preeclampsia, intrauterine growth restriction and stillbirth.
The prevalence of OSA among women is estimated to be 2-5%, but it remains underdiagnosed during pregnancy. In sleep apnea syndrome, a few data have shown better pregnancy and fetal outcome with the use continuous positive airway pressure (CPAP) therapy.
the hypothesis is in obese pregnant women that there could be a significant association between sleep apnea syndrome and hypertensive disorders, preeclampsia and adverse fetal outcomes This is a prospective study of Women with a body mass index of 35 kg.m2 or greater. The aim of this study is to determinate the prevalence of sleep apnea syndrome in obese pregnant women and the benefit of CPAP on the maternal and fetal outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Obstructive Sleep, Pregnancy Complications, Pre-Eclampsia, Obesity
Keywords
sleep apnea syndrome, obesity, pregnancy, preeclampsia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OSA in obese patient during pregnancy
Arm Type
Experimental
Arm Description
OSA in polysomnography
Arm Title
no OSA in obese patient during pregnancy
Arm Type
Experimental
Arm Description
no OSA in polysomnography
Intervention Type
Diagnostic Test
Intervention Name(s)
polysomnography
Primary Outcome Measure Information:
Title
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria
Time Frame
during the sleep time, an average 8 hours
Secondary Outcome Measure Information:
Title
occurrence of vascular disease
Description
High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia
Time Frame
from inclusion at the beginning of the management of pregnancy to delivery
Title
Evaluation of fetal impact by correlation of birth weight to gestational age
Time Frame
from inclusion at the beginning of the management of pregnancy to delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnancy
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
age >18 years
BMI > 35
> 24th weeks of pregnancy
informed consent,
health assurance
Exclusion Criteria:
no informed consent
twin pregnancy or more
no health assurance
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne-Frédérique Dalmas, MD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU,Hôpital Jeanne de Flandre
City
Lille
State/Province
North
ZIP/Postal Code
59037
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sleep Apnea Syndrome in Obese Women During Pregnancy
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