Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-26 @ 2:14 AM
Study NCT ID:
NCT03509805
Status:
COMPLETED
Last Update Posted:
2018-10-15
First Post:
2018-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Apnea Syndrome in Obese Women During Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 89}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-12', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-04-25', 'lastUpdatePostDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of apnea objectified by polysomnography according to specific neurophysiological criteria', 'timeFrame': 'during the sleep time, an average 8 hours'}], 'secondaryOutcomes': [{'measure': 'occurrence of vascular disease', 'timeFrame': 'from inclusion at the beginning of the management of pregnancy to delivery', 'description': 'High blood pressure (HTAG), Essential or chronic hypertension, preeclampsia, Severe preeclampsia'}, {'measure': 'Evaluation of fetal impact by correlation of birth weight to gestational age', 'timeFrame': 'from inclusion at the beginning of the management of pregnancy to delivery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sleep apnea syndrome', 'obesity', 'pregnancy', 'preeclampsia'], 'conditions': ['Apnea, Obstructive Sleep', 'Pregnancy Complications', 'Pre-Eclampsia', 'Obesity']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nthe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnancy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18 years\n* BMI \\> 35\n* \\> 24th weeks of pregnancy\n* informed consent,\n* health assurance\n\nExclusion Criteria:\n\n* no informed consent\n* twin pregnancy or more\n* no health assurance'}, 'identificationModule': {'nctId': 'NCT03509805', 'briefTitle': 'Sleep Apnea Syndrome in Obese Women During Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Sleep Apnea Syndrome in Obese Women During Pregnancy', 'orgStudyIdInfo': {'id': '2008_32'}, 'secondaryIdInfos': [{'id': '2009-A01018-49', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OSA in obese patient during pregnancy', 'description': 'OSA in polysomnography', 'interventionNames': ['Diagnostic Test: polysomnography']}, {'type': 'EXPERIMENTAL', 'label': 'no OSA in obese patient during pregnancy', 'description': 'no OSA in polysomnography', 'interventionNames': ['Diagnostic Test: polysomnography']}], 'interventions': [{'name': 'polysomnography', 'type': 'DIAGNOSTIC_TEST', 'armGroupLabels': ['OSA in obese patient during pregnancy', 'no OSA in obese patient during pregnancy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'state': 'North', 'country': 'France', 'facility': 'CHRU,Hôpital Jeanne de Flandre', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Anne-Frédérique Dalmas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}