Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-01-02 @ 12:32 AM
Study NCT ID:
NCT01030003
Status:
COMPLETED
Last Update Posted:
2012-03-07
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D012913', 'term': 'Snoring'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], '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': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'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'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1685}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-06', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2012-03-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal diagnosis of hypertension', 'timeFrame': '0-3 months after enrollment.'}], 'secondaryOutcomes': [{'measure': 'Infant birth centile', 'timeFrame': '0-3 months after enrollment.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep-Disordered Breathing', 'Snoring', 'Pregnancy', 'Fetal Growth Retardation', 'Pre-Eclampsia'], 'conditions': ['Sleep Apnea Syndromes']}, 'referencesModule': {'references': [{'pmid': '24179294', 'type': 'DERIVED', 'citation': "O'Brien LM, Bullough AS, Owusu JT, Tremblay KA, Brincat CA, Chames MC, Kalbfleisch JD, Chervin RD. Snoring during pregnancy and delivery outcomes: a cohort study. Sleep. 2013 Nov 1;36(11):1625-32. doi: 10.5665/sleep.3112."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the prevalence of sleep-disordered breathing in pregnant women during the third trimester of pregnancy and to investigate whether this is associated with high blood pressure in the mother and/or growth retardation in the baby.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible pregnant women are those receiving prenatal care and planning on delivering at the University of Michigan.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women attending obstetric clinics at University of Michigan Hospitals.\n* Willing and able to provide informed consent.\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Aged under 18 years'}, 'identificationModule': {'nctId': 'NCT01030003', 'briefTitle': 'Snoring in Pregnancy and Adverse Maternal and Fetal Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'The Impact of Sleep-Disordered Breathing on Adverse Pregnancy Outcomes', 'orgStudyIdInfo': {'id': 'R000038'}, 'secondaryIdInfos': [{'id': '1R21HL089918-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R21HL089918-01A1', 'type': 'NIH'}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': "Louise M O'Brien, PhD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': "Louise O'Brien", 'investigatorAffiliation': 'University of Michigan'}}}}