Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT04691934
Status:
COMPLETED
Last Update Posted:
2020-12-31
First Post:
2020-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Obstetric Anesthesia Experiences in COVID-19 Positive Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011014', 'term': 'Pneumonia'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'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': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-30', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2020-12-30', 'lastUpdatePostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'obstetric anesthesia practices', 'timeFrame': 'until 30 minutes after arrival in the operating room', 'description': 'the type of anesthesia was investigated'}], 'secondaryOutcomes': [{'measure': 'anesthesia complications', 'timeFrame': 'up to 1 hour after anesthesia', 'description': 'hypotension, nausea, vomiting, allergies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Anesthesia', 'Cesarean Section', 'Pneumonia'], 'conditions': ['Covid19', 'Obstetric Anesthesia']}, 'descriptionModule': {'briefSummary': 'At the end of 2019, a new coronavirus named COVID-19 (SARS-CoV-2), one of the lower respiratory tract samples was detected in China. The World Health Organization (WHO) declared it a global epidemic on March 11, 2020, due to the emergence of COVID-19 cases in 113 countries other than China, where the first epidemic occurred, and the spread and severity of the virus. Pregnancy increases susceptibility to respiratory complications of viral diseases.\n\nThis study aimed to retrospectively evaluate the demographic data of COVID-19 patients undergoing cesarean section, our anesthesia practices, complications, and condition of neonates, and to summarize up-to-date information on COVID-19 in obstetric anesthesia.', 'detailedDescription': 'Our study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information about anesthesia were analyzed retrospectively from the patient files.\n\nAll patients were operated in negative pressure operating theatres reserved for them. The whole team was equipped with Level 3 personal protective equipment (PPE) (liquid-proof apron, N-95 mask, goggles, visor, overshoes). Anesthesia was administered by 2 healthcare professionals from the anesthesia team, including an experienced anesthesiologist and an assistant anesthesia technician. A third person was kept ready outside to help in case of need.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent cesarean section and had positive PCR nasopharyngeal swabs for COVID-19', 'genderDescription': 'Patients who underwent cesarean section were included in the study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent cesarean section\n* Patients who had positive PCR nasopharyngeal swabs for COVID-19\n\nExclusion Criteria:\n\n* Patients who tested negative and were clinically suspicious'}, 'identificationModule': {'nctId': 'NCT04691934', 'briefTitle': 'Obstetric Anesthesia Experiences in COVID-19 Positive Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}, 'officialTitle': 'Our Anesthesia Experiences in COVID-19 Positive Patients Undergoing Cesarean Section: A Retrospective Single-center Cohort Study', 'orgStudyIdInfo': {'id': 'U1111-1263-2201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Anesthesia management', 'type': 'PROCEDURE', 'description': 'Patients who underwent cesarean section and had positive PCR nasopharyngeal swabs for COVID-19 were included in the study. Patients who tested negative and were clinically suspicious were excluded from the study. PCR test was not performed on all elective and emergency pregnant women to be taken for cesarean section in our hospital. It was only applied to patients with symptoms or patients who were suspected. All patient demographics and information about anesthesia were analyzed retrospectively from the patient files.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16290', 'city': 'Bursa', 'state': 'Yıldırım', 'country': 'Turkey (Türkiye)', 'facility': 'University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Derya Karasu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BursaYuksek Ihtisas Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Turkiye Yuksek Ihtisas Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc Prof.', 'investigatorFullName': 'Derya Karasu, MD', 'investigatorAffiliation': 'Turkiye Yuksek Ihtisas Education and Research Hospital'}}}}