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Sleep Apnea Syndrome in Obese Women During Pregnancy

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ClinicalTrials.gov Identifier: NCT03509805
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date  ICMJE April 24, 2018
First Posted Date  ICMJE April 26, 2018
Last Update Posted Date October 15, 2018
Actual Study Start Date  ICMJE September 1, 2010
Actual Primary Completion Date March 14, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria [ Time Frame: during the sleep time, an average 8 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03509805 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2018)
  • occurrence of vascular disease [ Time Frame: from inclusion at the beginning of the management of pregnancy to delivery ]
    High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep Apnea Syndrome in Obese Women During Pregnancy
Official Title  ICMJE Sleep Apnea Syndrome in Obese Women During Pregnancy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Apnea, Obstructive Sleep
  • Pregnancy Complications
  • Pre-Eclampsia
  • Obesity
Intervention  ICMJE Diagnostic Test: polysomnography
Study Arms  ICMJE
  • Experimental: OSA in obese patient during pregnancy
    OSA in polysomnography
    Intervention: Diagnostic Test: polysomnography
  • Experimental: no OSA in obese patient during pregnancy
    no OSA in polysomnography
    Intervention: Diagnostic Test: polysomnography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2018)
89
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 14, 2017
Actual Primary Completion Date March 14, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: pregnancy
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03509805
Other Study ID Numbers  ICMJE 2008_32
2009-A01018-49 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Lille
Study Sponsor  ICMJE University Hospital, Lille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anne-Frédérique Dalmas, MD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP