Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT02649933
Status:
TERMINATED
Last Update Posted:
2016-05-13
First Post:
2015-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Sleep Apnea Syndrome (OSA) in Pregnant Women and Assessment of Impact of OSA on Pregnancy Course
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'one investigator left the study site', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2015-12-17', 'studyFirstSubmitQcDate': '2016-01-06', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of sleep apnea syndrome (OSA) in obese pregnant women', 'timeFrame': '1 month', 'description': 'Positive OSA on Watch Pat 200 must be confirmed by polysomnography'}], 'secondaryOutcomes': [{'measure': 'composite score assessing pregnancy course and materno-foetal complications', 'timeFrame': '6 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy', 'obstructive sleep apnea'], 'conditions': ['Pregnancy', 'Sleep Apnea Syndrome', 'Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'To assess prevalence of obstructive sleep apnea during pregnancy and its impact on prgnancy course and materno foetal wellbeing.', 'detailedDescription': '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.\n\nTo 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.\n\nAs 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 .\n\nOral 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.\n\nAim of the study:\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women, 12-15weeks of pregnancy, obese (body mass index\\>30)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women\n* 12-15weeks of pregnancy\n* obese (body mass index\\>30)\n\nExclusion Criteria:\n\n* known sleep apnea syndrome\n* mental illness, deficiency'}, 'identificationModule': {'nctId': 'NCT02649933', 'briefTitle': 'Detection of Sleep Apnea Syndrome (OSA) in Pregnant Women and Assessment of Impact of OSA on Pregnancy Course', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Saint Pierre'}, 'officialTitle': 'Detection of Sleep Apnea Syndrome (OSA) With Watch PAT 200 in Pregnant Women and Assessment of Impact of OSA on Intra-uterine Fetal Growth and Maternal Well-being', 'orgStudyIdInfo': {'id': 'AK/14-11-105/4434'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Watch PAt 200', 'description': 'obese pregnant women, pregnancy between 12 and 15 weeks', 'interventionNames': ['Device: Watch PAT 200']}], 'interventions': [{'name': 'Watch PAT 200', 'type': 'DEVICE', 'description': 'screening of OSA with Watch PAT 200', 'armGroupLabels': ['Watch PAt 200']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU St Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Saint Pierre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chef de clinique service de pneumologie', 'investigatorFullName': 'Marie Bruyneel', 'investigatorAffiliation': 'Centre Hospitalier Universitaire Saint Pierre'}}}}