Sleep Apnea Syndrome in Obese Women During Pregnancy

NCT03509805 | Completed

• 2 other identifiers: 2008_322009-A01018-49
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

sleep apnea syndrome; obesity; pregnancy; preeclampsia

Outcome Measures

Primary Outcomes (1)

• Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria

  during the sleep time, an average 8 hours

Secondary Outcomes (2)

• occurrence of vascular disease

  from inclusion at the beginning of the management of pregnancy to delivery

• Evaluation of fetal impact by correlation of birth weight to gestational age

  from inclusion at the beginning of the management of pregnancy to delivery

Study Arms (2)

OSA in obese patient during pregnancy

EXPERIMENTAL

OSA in polysomnography

Diagnostic Test: polysomnography

no OSA in obese patient during pregnancy

EXPERIMENTAL

no OSA in polysomnography

Diagnostic Test: polysomnography

Interventions

polysomnography DIAGNOSTIC_TEST

OSA in obese patient during pregnancy; no OSA in obese patient during pregnancy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>18 years
• BMI \> 35
• \> 24th weeks of pregnancy
• informed consent,
• health assurance

You may not qualify if:

• no informed consent
• twin pregnancy or more
• no health assurance

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHRU,Hôpital Jeanne de Flandre

Lille, North, 59037, France

Location

Related Publications (1)

• Ghesquiere L, Deruelle P, Ramdane Y, Garabedian C, Charley-Monaca C, Dalmas AF. Obstructive sleep apnea in obese pregnant women: A prospective study. PLoS One. 2020 Sep 8;15(9):e0238733. doi: 10.1371/journal.pone.0238733. eCollection 2020.

  PMID: 32898189 RESULT

MeSH Terms

Conditions

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

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension, Pregnancy-Induced; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Anne-Frédérique Dalmas, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: April 26, 2018
• Study Start: September 1, 2010
• Primary Completion: March 14, 2017
• Study Completion: March 14, 2017
• Last Updated: April 22, 2026

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)