Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2026-02-20 @ 6:04 PM
Study NCT ID:
NCT03280706
Status:
COMPLETED
Last Update Posted:
2018-02-07
First Post:
2017-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-03-10', 'releaseDate': '2020-02-26'}], 'estimatedResultsFirstSubmitDate': '2020-02-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}, {'id': 'D003069', 'term': 'Coffee'}, {'id': 'D008892', 'term': 'Milk'}], 'ancestors': [{'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Investigator and outcomes assessor will not know to which group each woman was allocated'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-06', 'studyFirstSubmitDate': '2017-09-09', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2018-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Gastric antral area', 'timeFrame': 'baseline (before drinking allocated solution), 30, 60, 90 and 120 minutes after drinking.', 'description': 'Change from Baseline Gastric antral area measured by ultrasound'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Emptying', 'labor', 'maltodextrin', 'orange juice', 'coffee', 'ultrasound'], 'conditions': ['Gastric Emptying', 'Pregnancy Vomits']}, 'descriptionModule': {'briefSummary': 'This study evaluates the gastric emptying of pregnant woman at term who received one of the three solutions: maltodextrin, orange juice or coffee with milk.', 'detailedDescription': 'Allocation in maltodextrin, orange juice or coffee with milk will be random using sealed envelopes. Gastric ultrasound will be used for estimating gastric volume by measuring antral area in right lateral decubiti. All solutions will have the same volume and total of calories.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnancy at term\n* Fasted with an emptying stomach (assessed by ultrasound)\n* During Labor\n* No diabetes, esophageal disease, obesity\n* Not emergency\n* High risk of need of general anesthesia\n\nExclusion Criteria:\n\n* Vomiting before the end of the protocol\n* Did not drink the whole solutions\n* Ultrasound not performed for any reason'}, 'identificationModule': {'nctId': 'NCT03280706', 'acronym': 'GEMCO', 'briefTitle': 'Gastric Emptying During Labor at Term: Non-inferiority Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'Brasilia University Hospital'}, 'officialTitle': 'Gastric Emptying of Maltodextrin Compared to Coffee With Milk and Orange Juice During Labor at Term: Non-inferiority Clinical Trial', 'orgStudyIdInfo': {'id': 'tcc-anele-2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Maltodextrin', 'description': 'Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of maltodextrin 200kcal, no protein or fat, 49,5g of carbohydrate.', 'interventionNames': ['Dietary Supplement: Maltodextrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Orange Juice', 'description': 'Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of orange juice, 200kcal, 2,82g of protein, 0,67g of fat, 47,08g of carbohydrate.', 'interventionNames': ['Dietary Supplement: Orange Juice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coffee with milk', 'description': 'Fasted pregnant woman with an empty stomach (assessed by ultrasound) will drink 500ml of coffee with milk, 200kcal, 10,6g of protein, 10,73g of fat, 14,9g of carbohydrate.', 'interventionNames': ['Dietary Supplement: Coffee with milk']}], 'interventions': [{'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Maltodextrin 50g in water 500ml', 'armGroupLabels': ['Maltodextrin']}, {'name': 'Orange Juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Orange juice 480ml + 20ml of water', 'armGroupLabels': ['Orange Juice']}, {'name': 'Coffee with milk', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Coffee with milk (330 ml of milk + 220 of water)', 'armGroupLabels': ['Coffee with milk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7000000', 'city': 'BrasÃlia', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'University Hospital of Brasilia University', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}], 'overallOfficials': [{'name': 'Gabriel MN Guimaraes, MsC', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario de Brasilia'}]}, 'ipdSharingStatementModule': {'url': 'http://www.anestesiologiaunb.com.br', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': '6 months after the end of the study', 'ipdSharing': 'YES', 'description': 'Will make it available in our website', 'accessCriteria': 'Open access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Brasilia University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of anesthesiology', 'investigatorFullName': 'Gabriel Magalhaes Nunes Guimaraes', 'investigatorAffiliation': 'Brasilia University Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-02-26', 'type': 'RELEASE'}, {'date': '2020-03-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gabriel Magalhaes Nunes Guimaraes, Head of anesthesiology, Brasilia University Hospital'}}}}