Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:18 PM
Study NCT ID:
NCT05553756
Status:
UNKNOWN
Last Update Posted:
2022-09-23
First Post:
2022-03-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C008315', 'term': 'maltodextrin'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-21', 'studyFirstSubmitDate': '2022-03-31', 'studyFirstSubmitQcDate': '2022-09-21', 'lastUpdatePostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glycemic stability', 'timeFrame': 'perioperative', 'description': 'blood glucose levels \\<180 mg/dl'}, {'measure': 'hemodynamic stability', 'timeFrame': 'perioperative', 'description': 'mean arterial pressure \\> 70 mmHg during perioperative time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'The goal is to evaluate the glycemic and hemodynamic stability in patients undergoing caesarean section in patients treated with maltodextrins two hours before the cesarean section', 'detailedDescription': 'The patients undergoing elective cesarean section will be randomly divided in two groups: patients who drink 200 ml of clear liquid two hours before surgery or patients treated with 200 ml maltodextrins two hours before the surgery. The glycemic control will be done immediately before the maldodextrin administration and after the cesarean section by gluco stick. Standard hemodynamic monitoring ECG, Heart Rate, Blood pressure, Temperature, preipheral oxygen saturation will be done routinely.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* first cesarean section\n* single fetus\n* ASA I-II\n\nExclusion Criteria:\n\n* BMI\\<18\n* BMI\\>35\n* contraindication to spinal anesthesia\n* cardiovascular diseases'}, 'identificationModule': {'nctId': 'NCT05553756', 'acronym': 'MALTO-TC', 'briefTitle': 'Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University of Foggia'}, 'officialTitle': 'Impact of Maltodextrin, Given 2 Hours Before Cesarean Section, on Glycemic and Hemodynamic Management of Pregnant', 'orgStudyIdInfo': {'id': '08/CE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'preoperative clear liquid', 'description': 'Patients will drink 200 ml of clear liquid two hours before Cesarean section'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'preoperative maltodextrin', 'description': 'Patients will drink 200 ml of maltodexin two hours before Cesarean section', 'interventionNames': ['Dietary Supplement: Maltodextrin']}], 'interventions': [{'name': 'Maltodextrin', 'type': 'DIETARY_SUPPLEMENT', 'description': '200 ml maltodextrin given 2 hours before cesarean section', 'armGroupLabels': ['preoperative maltodextrin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71122', 'city': 'Foggia', 'country': 'Italy', 'facility': 'University of Foggia', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Foggia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Casa Sollievo della Sofferenza IRCCS', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Cotoia Antonella', 'investigatorAffiliation': 'University of Foggia'}}}}