Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02654067
Status:
WITHDRAWN
Last Update Posted:
2019-09-19
First Post:
2015-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Mallampati Score Changes in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015903', 'term': 'Moire Topography'}], 'ancestors': [{'id': 'D010780', 'term': 'Photogrammetry'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D007368', 'term': 'Interferometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lack of available personnel to conduct data acquisition and analysis', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2015-11-25', 'studyFirstSubmitQcDate': '2016-01-11', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mallampati score changes during pregnancy', 'timeFrame': '40 weeks', 'description': 'mallampati scores classification from 1 to 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '4027773', 'type': 'RESULT', 'citation': 'Mallampati SR, Gatt SP, Gugino LD, Desai SP, Waraksa B, Freiberger D, Liu PL. A clinical sign to predict difficult tracheal intubation: a prospective study. Can Anaesth Soc J. 1985 Jul;32(4):429-34. doi: 10.1007/BF03011357.'}, {'pmid': '18292672', 'type': 'RESULT', 'citation': 'Kodali BS, Chandrasekhar S, Bulich LN, Topulos GP, Datta S. Airway changes during labor and delivery. Anesthesiology. 2008 Mar;108(3):357-62. doi: 10.1097/ALN.0b013e31816452d3.'}, {'pmid': '7640115', 'type': 'RESULT', 'citation': 'Pilkington S, Carli F, Dakin MJ, Romney M, De Witt KA, Dore CJ, Cormack RS. Increase in Mallampati score during pregnancy. Br J Anaesth. 1995 Jun;74(6):638-42. doi: 10.1093/bja/74.6.638.'}]}, 'descriptionModule': {'briefSummary': 'Pregnant patients mallampati class scores will be examined throughout pregnancy', 'detailedDescription': 'Photographs of the airway will be taken and compared throughout labor and delivery'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant\n* at least 18 years of age\n\nExclusion Criteria:\n\n* refusal of consent\n* known difficult airway'}, 'identificationModule': {'nctId': 'NCT02654067', 'briefTitle': 'Evaluation of Mallampati Score Changes in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Evaluation of Mallampati Score Changes in Pregnancy', 'orgStudyIdInfo': {'id': 'Pregnancy Airway Study'}}, 'armsInterventionsModule': {'interventions': [{'name': 'photograph', 'type': 'PROCEDURE', 'description': 'photograph of airway'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Julian Robinson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief of Obstetrics', 'investigatorFullName': 'Julian N Robinson', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}