Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT04337320
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2020-04-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Maternal And Neonatal Outcome of Pregnant Patients With COVID-19 in Istanbul, Turkey: A Single-Center, Retrospective, Descriptive Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-09', 'studyFirstSubmitDate': '2020-04-05', 'studyFirstSubmitQcDate': '2020-04-06', 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of apgar status of newborns from covid 19 positive mothers', 'timeFrame': '2 months', 'description': "The Apgar score is looked after at 1 and 5 minutes after birth, if the baby's Apgar score is lower than 7, it is repeated every 5 minutes until 20 minutes. Parameters examined in Apgar score Muscle tone, Heart rate, Reflexes, Skin color, Respiration.\n\nIn the Apgar score, the baby is evaluated and scores are collected.\n\n7 - 10: The baby is normal.\n\n4 - 6: They usually recover with respiratory support.\n\n0 - 3: Urgent intervention and resuscitation is needed.\n\nThe low Apgar score in the 1st minute usually returns to normal in the 5th minute with support. Despite the intervention, the Apgar scores of 5 and less at 5 and 10 minutes are associated with an increased risk of mortality and cerebral palsy."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Covid19', 'Maternal-Fetal Relations']}, 'descriptionModule': {'briefSummary': 'Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Minutes', 'minimumAge': '1 Minute', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* from covid 19 positive mothers\n* newborn mothers had not other condition or illness\n\nExclusion Criteria:\n\n* from covid 19 negative mothers\n* childs'}, 'identificationModule': {'nctId': 'NCT04337320', 'briefTitle': 'Maternal And Neonatal Outcome of Pregnant Patients With COVID-19 in Istanbul, Turkey: A Single-Center, Retrospective, Descriptive Study', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Maternal And Neonatal Outcome of Pregnant Patients With COVID-19', 'orgStudyIdInfo': {'id': 'covid19pregnancynewborn'}}, 'armsInterventionsModule': {'interventions': [{'name': 'newborns from covid 19 positive mothers', 'type': 'OTHER', 'description': 'Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Istanbul', 'state': 'İ̇stanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Pinar Yalcin Bahat', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seda Yilmaz Semerci', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Merve Aldikactioglu Talmac, MD', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}