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Sleep Apnea Syndrome in Obese Women During Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03509805
Recruitment Status : Completed
First Posted : April 26, 2018
Last Update Posted : October 15, 2018
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease Intervention/treatment Phase
Apnea, Obstructive Sleep Pregnancy Complications Pre-Eclampsia Obesity Diagnostic Test: polysomnography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sleep Apnea Syndrome in Obese Women During Pregnancy
Actual Study Start Date : September 1, 2010
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : March 14, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: OSA in obese patient during pregnancy
OSA in polysomnography
Diagnostic Test: polysomnography
Experimental: no OSA in obese patient during pregnancy
no OSA in polysomnography
Diagnostic Test: polysomnography

Primary Outcome Measures :
  1. Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria [ Time Frame: during the sleep time, an average 8 hours ]

Secondary Outcome Measures :
  1. 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

  2. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnancy
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03509805

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CHRU,Hôpital Jeanne de Flandre
Lille, North, France, 59037
Sponsors and Collaborators
University Hospital, Lille
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Principal Investigator: Anne-Frédérique Dalmas, MD University Hospital, Lille
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Responsible Party: University Hospital, Lille Identifier: NCT03509805    
Other Study ID Numbers: 2008_32
2009-A01018-49 ( Other Identifier: ID-RCB number, ANSM )
First Posted: April 26, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
sleep apnea syndrome
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Hypertension, Pregnancy-Induced
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pregnancy Complications
Signs and Symptoms, Respiratory