Sleep Apnea Syndrome in Obese Women During Pregnancy

U

University Hospital, Lille

Status

Completed

Conditions

Pre-Eclampsia
Pregnancy Complications
Apnea, Obstructive Sleep
Obesity

Treatments

Diagnostic Test: polysomnography

Study type

Interventional

Funder types

Other

Identifiers

NCT03509805
2008_32
2009-A01018-49 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

89 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

89 participants in 2 patient groups

OSA in obese patient during pregnancy
Experimental group
Description:
OSA in polysomnography
Treatment:
Diagnostic Test: polysomnography
no OSA in obese patient during pregnancy
Experimental group
Description:
no OSA in polysomnography
Treatment:
Diagnostic Test: polysomnography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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