Sleep Apnea Syndrome in Obese Women During Pregnancy

Obesity Clinical Trial

Official title:

Sleep Apnea Syndrome in Obese Women During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509805
• Other study ID #: 2008_32
• Secondary ID: 2009-A01018-49
• Status: Completed
• Phase: N/A
• Start date: September 1, 2010
• Est. completion date: March 14, 2017

Study information

• Verified date: October 2018
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 14, 2017
• Est. primary completion date: March 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• polysomnography

Locations

Country	Name	City	State
France	CHRU,Hôpital Jeanne de Flandre	Lille	North

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria		during the sleep time, an average 8 hours
Secondary	occurrence of vascular disease	High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia	from inclusion at the beginning of the management of pregnancy to delivery
Secondary	Evaluation of fetal impact by correlation of birth weight to gestational age		from inclusion at the beginning of the management of pregnancy to delivery