Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-31 @ 3:02 PM
Study NCT ID:
NCT03800251
Status:
UNKNOWN
Last Update Posted:
2019-01-11
First Post:
2019-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients who are fasting according to the guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hrs before their scheduled theatre time and will then have their gastric volume assessed at 15min intervals for 2hrs to determine how long it takes for the ingested fluid to leave the stomach.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-10', 'studyFirstSubmitDate': '2019-01-06', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time interval required to return to the fasting grade.', 'timeFrame': '2 hours', 'description': 'The stomach will be scanned and graded (Perlas grade 0-2) every 15 minutes based on the presence or absence of clear fluid in supine and right lateral decubitus position at 45 degrees elevation of the upper body, after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).'}], 'secondaryOutcomes': [{'measure': 'Number of participants with grade 0, 1 and 2 in fasting term parturients attending for elective cesarean section', 'timeFrame': '10 minutes', 'description': 'Initial "fasting" scan will be performed in all patients'}, {'measure': 'Time taken for the antral cross sectional area (measured by ultrasound) to reach <9.6 cm2 (suggested cut off value for ingested volumes < 1.5ml.kg-1) after ingesting 400 ml carbohydrate drink', 'timeFrame': '2 hours', 'description': 'Sequential ultrasound scans will be performed at 15 min intervals for 2 hours.'}, {'measure': 'Antral cross sectional area at 2 hours', 'timeFrame': '2 hours', 'description': 'Ultrasound measurement of antral cross sectional area will be performed at 2 hours after consumption of 400 ml clear carbohydrate drink (Nutricia PreOp).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Emptying', 'Pregnancy', 'Elective Cesarean section', 'Fasting'], 'conditions': ['Gastric Emptying', 'Pregnancy']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp).', 'detailedDescription': "Recent research suggests that attention to nutrition before operation leads to a speedier recovery through moderating the metabolic responses to surgery, improving well-being, decreasing post-operative insulin resistance and attenuation loss of lean body mass. On other hand there are fasting guidelines in place to prevent from pulmonary aspiration. The current fasting guidelines of 2hrs for clear fluids come from some small studies performed in healthy non-pregnant adults and consensus agreement.\n\nThe aim of the study is to use sequential ultrasound evaluation of the gastric volume to determine how long it takes for the stomach of a fasting pregnant woman at term, admitted for elective cesarean section, to empty after ingesting a 400ml carbohydrate drink (Nutricia preOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml).\n\nPatients who are fasting according to the current guidelines and agree to partake in the study will, on the day of their elective LSCS, be given a 400ml carbohydrate drink at least 2hours before their scheduled theatre time. Patients will then have their gastric volume assessed at 15minutes intervals for 2 hours to determine how long it takes for the ingested fluid to leave the stomach. The results of the study will give us more information regarding gastric emptying in the investigator's patient population and may lead to reduced fasting times, increasing patient comfort and improving the patient experience."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective LSCS\n* 18yrs\n* gestation \\>38 gestation weeks\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Previous upper GI surgery\n* Known disorder of gastric emptying\n* Hiatus Hernia\n* BMI \\>40\n* Diabetes Mellitus, Gestational Diabetes'}, 'identificationModule': {'nctId': 'NCT03800251', 'briefTitle': 'Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Coombe Women and Infants University Hospital'}, 'officialTitle': 'Rate of Gastric Emptying in Term Parturients Undergoing Elective Cesarean Section', 'orgStudyIdInfo': {'id': '8-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Fasting parturients at term', 'description': 'Fasting parturients at term, admitted for elective cesarean section, who consent to partake in the study', 'interventionNames': ['Dietary Supplement: Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml']}], 'interventions': [{'name': 'Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink', 'armGroupLabels': ['Fasting parturients at term']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'D08XW7X', 'city': 'Dublin', 'status': 'RECRUITING', 'country': 'Ireland', 'contacts': [{'name': 'Petar Popivanov, Dr', 'role': 'CONTACT', 'email': 'ppopivanov@coombe.ie', 'phone': '+353 (01) 408 5662'}, {'name': 'Michelle Walsh, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Coombe Women and Infants University Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}], 'centralContacts': [{'name': 'Petar Popivanov', 'role': 'CONTACT', 'email': 'ppopivanov@coombe.ie', 'phone': '+353 (01) 4085662'}, {'name': 'Michelle Walsh', 'role': 'CONTACT', 'email': 'michowalsh@gmail.com', 'phone': '+353 (01) 4085662'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'At the moment there is no plan whether or not to make the IPD available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coombe Women and Infants University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Anaesthetist', 'investigatorFullName': 'Petar Popivanov', 'investigatorAffiliation': 'Coombe Women and Infants University Hospital'}}}}