Sleep Apnea Syndrome in Obese Women During Pregnancy

NCT ID: NCT03509805

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-01

Study Completion Date

2017-03-14

Brief Summary

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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

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Conditions

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Apnea, Obstructive Sleep Pregnancy Complications Pre-Eclampsia Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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OSA in obese patient during pregnancy

OSA in polysomnography

Group Type EXPERIMENTAL

polysomnography

Intervention Type DIAGNOSTIC_TEST

no OSA in obese patient during pregnancy

no OSA in polysomnography

Group Type EXPERIMENTAL

polysomnography

Intervention Type DIAGNOSTIC_TEST

Interventions

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polysomnography

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Frédérique Dalmas, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CHRU,Hôpital Jeanne de Flandre

Lille, North, France

Site Status

Countries

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France

Other Identifiers

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2009-A01018-49

Identifier Type: OTHER

Identifier Source: secondary_id

2008_32

Identifier Type: -

Identifier Source: org_study_id

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