Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-28 @ 4:54 PM
Study NCT ID:
NCT04014504
Status:
COMPLETED
Last Update Posted:
2019-07-12
First Post:
2019-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pethidine Analgesia and Neonatal Hearing Screening Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-11', 'studyFirstSubmitDate': '2019-07-07', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal Hearing Screening Test', 'timeFrame': '2 week', 'description': 'neonatal hearing screening test results will be evaluated. will be reported as left or passed.\n\nThe "pass\'\' en response observed in the hearing screening device indicates that the baby passed the screening test, and the" refer "response indicates that the baby has failed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Newborn Hearing Screening', 'Otoacoustic emissions', 'Pethidine', 'False positive'], 'conditions': ['Hearing Loss', 'Newborn Complication']}, 'descriptionModule': {'briefSummary': 'Neonatal hearing screening may fail due to some perinatal and neonatal factors. It is well known that false positivity in newborn hearing screening increases cost and maternal anxiety and anxiety. There is still widespread concern about the use of opoid analgesics to relieve pain during labor. The aim of this study was to determine the effects of pethidine administered during labor on neonatal hearing screening test false positivity rates.', 'detailedDescription': 'The study group consisted of patients receiving 50 mg intramuscular (I.M) pethidine at the beginning of the active phase of labor and the control group consisted of patients not receiving pethidine. Newborns were evaluated by otoacoustic emission (OAE) test. The OAE test was performed before the patients were discharged. Perinatal and neonatal variables and test results were recorded and the relationship between false positivity and pethidine use was evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '24 Hours', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'term singleton pregnancy,Gave birth at 37-41 weeks of gestation, without chronic internal disease,Pregnant women were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* term singleton pregnancy,\n* Gave birth at 37-41 weeks of gestation,\n* without chronic internal disease,\n* Pregnant women were included in the study.\n\nExclusion Criteria:\n\n* Newborn hospitalized in intensive care,\n* congenital / chromosomal anomaly,\n* congenital CMV infection,\n* facial / ear deformities,\n* family with hearing problems,\n* those with hyperbilirunemia,\n* tested at \\<12 hours after birth,\n* maternal infection,\n* Diabetes mellitus, recurrent abortion,\n* smoking,\n* plesanta previa,\n* prolonged premature rupture of the membrane (more than 12 hours), epidural -analgesia and\n* newborns who were at risk of asphyxia hypoxia were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT04014504', 'briefTitle': 'Pethidine Analgesia and Neonatal Hearing Screening Test', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Effect of Pethidine Analgesia on False Positivity in Neonatal Hearing Screening Test', 'orgStudyIdInfo': {'id': '2019.07.07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study group', 'description': 'The results of the hearing screening test of the beats of the patients who have undergone pethidine in the active phase of labor will be examined. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at.', 'interventionNames': ['Diagnostic Test: Neonatal Hearing Screening Test']}, {'label': 'control group', 'description': 'In the active phase of labor, hearing screening test results of beats of pediatric patients will be evaluated. the results will be reported as passed - remained; the false positivity rate according to the retest of the remaining group is to be looked at. control group.', 'interventionNames': ['Diagnostic Test: Neonatal Hearing Screening Test']}], 'interventions': [{'name': 'Neonatal Hearing Screening Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'neonatal hearing screening test results will be evaluated.', 'armGroupLabels': ['control group', 'study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33404', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni Sultan Süleyman Training and Research Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator, M.D, Department of Obstetrics and Gynecology', 'investigatorFullName': 'Pınar Kadirogulları', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}