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OpenTrials
Completed

NCT Number: NCT03509805

Sleep Apnea Syndrome in Obese Women During Pregnancy

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnography

Diagnostic Test

Primary outcomes

  1. Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria

    Time frame: during the sleep time, an average 8 hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Apr 26, 2018
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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