Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-27 @ 6:17 AM
Study NCT ID:
NCT02029859
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2014-01-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Apnea, Obesity and Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'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'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 205}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-02', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-07', 'lastUpdatePostDateStruct': {'date': '2015-06-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep apnea syndrom prevalence', 'timeFrame': '6 weeks', 'description': 'Polygraphic examination for all subjects will determine the sleep apnea syndrom prevalence during late pregnancy (after 30 weeks of amenorhea) for severe obese women (BMI\\>35).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pregnancy (after 30 weeks of amenorhea)', 'obesity (BMI>35)', 'sleep apnea syndrom', 'preeclampsy', 'intrauterine growth restriction'], 'conditions': ['Obesity', 'Pregnancy']}, 'descriptionModule': {'briefSummary': "Main objective:\n\nDetermine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .\n\nSecondary objectives :\n\n* Identify risk factors for OSA during pregnancy (age, parity, high blood pressure, snoring , weight, neck circumference, scores on symptoms of sleep apnea, ... ) .\n* Compare perinatal morbidity among obese patients with OSA in late pregnancy with case-controls.\n* Evaluate the evolution of a moderate or severe OSA 6 months after pregnancy.\n\nMaterial and methods\n\nCharacteristics of the study:\n\n* Interventional biomedical research\n* Prospective Multicenter nonrandomized study\n\nFlow chart\n\n* Patients will be included between 30 and 36 weeks of amenorrhea (WA) .\n* Will rated from inclusion: age, parity, weight, height, BMI in early pregnancy, neck circumferrence, treated high blood pressure.\n* As recommended in France, the main test results during the pregnancy follow-up will be recorded.\n* At the inclusion visit will be conducted a Berlin Questionnaire and Epworth Score.\n* Screening for OSA by nocturnal polysomnography will be performed between 30 and 36WA. This screening can be performed as an outpatient.\n* In case of proven OSA patients will be offered an appropriate care by today's standards.\n* Whatever the outcome of pregnancy, a second polysomnography will be performed 6 months after childbirth in case of OSA during pregnancy."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\>35\n* Pregnancy after 30 Weeks of amenorhea\n* Age \\> 18\n* Signed consentment\n* Nationnal Health Program affiliation\n\nExclusion Criteria:\n\n* Twin or more pregnancy\n* Imprecise term\n* Artificial insemination with donor gametes\n* Proved thrombophilia\n* chronic renal failure\n* Previously treated (with CPAP) obstructive sleep apnea syndrom'}, 'identificationModule': {'nctId': 'NCT02029859', 'acronym': 'GOS', 'briefTitle': 'Sleep Apnea, Obesity and Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Rouen'}, 'officialTitle': 'Sleep Apnea, Obesity and Pregnancy', 'orgStudyIdInfo': {'id': '2009/070/HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prevalence of obstructive sleep apnea syndrome', 'description': 'Determine the prevalence of obstructive sleep apnea syndrome (OSA) in late pregnancy in a population of obese patients .\n\nPolygraphic examination between 30 and 36 weeks of amenorhea', 'interventionNames': ['Procedure: Polygraphic examination']}], 'interventions': [{'name': 'Polygraphic examination', 'type': 'PROCEDURE', 'description': 'Polygraphic examination between 30 and 36 weeks of amenorhea', 'armGroupLabels': ['Prevalence of obstructive sleep apnea syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49000', 'city': 'Angers', 'country': 'France', 'facility': 'Angers University Hospital', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'Caen University Hospital', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '76290', 'city': 'Le Havre', 'country': 'France', 'facility': 'Le Havre Hospital', 'geoPoint': {'lat': 49.49346, 'lon': 0.10785}}, {'zip': '76000', 'city': 'Rouen', 'country': 'France', 'facility': 'Rouen University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'overallOfficials': [{'name': 'Loic Marpeau, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Rouen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Rouen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}