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Sleep Apnea Syndrome in Obese Women During Pregnancy

Sleep Apnea Syndrome in Obese Women During Pregnancy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03509805
Enrollment
89
Registered
2018-04-26
Start date
2010-09-01
Completion date
2017-03-14
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Apnea, Obstructive Sleep, Obesity, Pre-Eclampsia, Pregnancy Complications

Keywords

sleep apnea syndrome, obesity, pregnancy, preeclampsia

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.

Interventions

DIAGNOSTIC_TESTpolysomnography

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteriaduring the sleep time, an average 8 hours

Secondary

MeasureTime frameDescription
occurrence of vascular diseasefrom inclusion at the beginning of the management of pregnancy to deliveryHigh blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia
Evaluation of fetal impact by correlation of birth weight to gestational agefrom inclusion at the beginning of the management of pregnancy to delivery

Countries

France

Contacts

PRINCIPAL_INVESTIGATORAnne-Frédérique Dalmas, MD

University Hospital, Lille

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026