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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02649933
Other study ID # AK/14-11-105/4434
Secondary ID
Status Terminated
Phase N/A
First received December 17, 2015
Last updated May 11, 2016
Start date November 2015
Est. completion date April 2016

Study information

Verified date May 2016
Source Centre Hospitalier Universitaire Saint Pierre
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.


Description:

During pregnancy, obstructive sleep apnea (OSA) prevalence is estimated between 5% and 15% and is associated with maternal and fetal comorbidities such as preeclampsia, neonatal intensive care admission , fetal growth retardation , preterm birth but even if growing, literature is still relatively poor about this topic.

To date, there is no systematic screening of OSA performed in at-risk pregnant women (obesity, hypertension, diabetes, fetal growth retardation, suggestive symptoms), probably mainly because of polysomnography complexity and accessibility.

As in non pregnant woman, OSA must be treated adequately during pregnancy. Continuous positive airway pressure (CPAP) is the reference treatment for severe OSA. This device, by blowing air under pressure in upper airways, via a nasal of an oro-nasal mask, is able to alleviate the upper airway collapse responsible for the occurrence of obstructive sleep apnea. It has been proven to offer a survival benefit in patients with severe disease and to improve sleep quality, cardiovascular variables and health-related quality of life . CPAP have been shown to improve fetal well-being in pre-eclampsia .

Oral appliance can be an alternative for mild to moderate disease and in patients who do not tolerate CPAP. Positional counselling can be sufficient in case of mild to moderate positional OSA. Associated behavioural strategies (diet and exercise) are always recommended in case of excessive weight. Surgical treatments are dedicated to patients with specific anatomic problems but cannot be performed during pregancy.

Aim of the study:

The primary aim of this study is to screen OSA in at risk pregnant women with Watch-PAT 200, a simplified sleep study tool used on ambulatory mode and able to detect accurately OSA in suspected patients. As secondary aim, we will observe the impact of OSA on a composite endpoint assessing materno-fetal wellbeing.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date April 2016
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- pregnant women

- 12-15weeks of pregnancy

- obese (body mass index>30)

Exclusion Criteria:

- known sleep apnea syndrome

- mental illness, deficiency

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
Watch PAT 200
screening of OSA with Watch PAT 200

Locations

Country Name City State
Belgium CHU St Pierre Brussels

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Saint Pierre

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary prevalence of sleep apnea syndrome (OSA) in obese pregnant women Positive OSA on Watch Pat 200 must be confirmed by polysomnography 1 month No
Secondary composite score assessing pregnancy course and materno-foetal complications assessment of one composite score componed by on several parameters including Apgar Score,fœtal anoxia, intra-uterine growth retardation, low birth weight, prematurity, placental abruption,preeclamspia, foetal death In Utero 6 months No
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