Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06391151
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-03', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-25', 'lastUpdatePostDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'pregnancy complications', 'timeFrame': '10 months'}, {'measure': 'neonatal birth weight', 'timeFrame': '10 months', 'description': 'birth weight of newborns measured in grams'}, {'measure': 'neonatal length', 'timeFrame': '10 months', 'description': 'length of newborns measured in centimeters'}, {'measure': 'Apgar score of newborns', 'timeFrame': '10 months', 'description': 'The Apgar score consists of five main indicators: skin color, heart rate, response to stimulation, muscle tone, and respiration. Each indicator is scored from 0 to 2, with a total score of 10. This scoring method serves as a guiding tool for the resuscitation of newborns with asphyxia and could provide a degree of predictive value for the neurological development of infants in the future.'}], 'primaryOutcomes': [{'measure': 'preterm birth rate', 'timeFrame': '10 months'}], 'secondaryOutcomes': [{'measure': 'delivery methods', 'timeFrame': '10 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea', 'Chronic Tonsillitis', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) resulting from chronic tonsillitis on pregnancy outcomes. The hypothesis posits that chronic tonsillitis-induced OSA may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant women who have established prenatal care records and undergone antenatal check-ups at PKUFH', 'genderDescription': 'pregnancy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women confirmed with chronic tonsillitis by clinical diagnosis and presenting symptoms.\n* Pregnant women with a confirmed diagnosis of OSA based on polysomnography or other validated sleep monitoring techniques.\n* Pregnant women who are willing to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\n* Pregnant women with other respiratory or sleep disorders that may confound the diagnosis of OSA.\n* Pregnant women with severe comorbidities or medical conditions that may significantly impact pregnancy outcomes.\n* Pregnant women who have undergone surgical treatment for chronic tonsillitis or OSA during the study period.\n* Pregnant women who refuse to participate in the study or are unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06391151', 'briefTitle': 'Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Effect of Obstructive Sleep Apnea (OSA) Resulting From Chronic Tonsillitis on Pregnancy Outcomes', 'orgStudyIdInfo': {'id': 'PKUFH ENT TLP V1.0'}}, 'armsInterventionsModule': {'interventions': [{'name': 'exposure: OSA resulting from chronic tonsillitis', 'type': 'OTHER', 'description': 'exposure: OSA resulting from chronic tonsillitis'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Xiaowan Du', 'role': 'CONTACT', 'email': 'xiaowandu26@126.com', 'phone': '13552834319'}], 'overallOfficials': [{'name': 'Xiaowan Du', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will be provided upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xiaowan Du', 'investigatorAffiliation': 'Peking University First Hospital'}}}}