Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-11 @ 11:43 PM
Study NCT ID:
NCT03732404
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2018-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which was used.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a randomized, placebo-controlled, study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2018-11-03', 'studyFirstSubmitQcDate': '2018-11-05', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': '3 weeks', 'description': 'Number of days in the hospital for each participant between the groups.'}], 'secondaryOutcomes': [{'measure': 'number of participants experienced nausea', 'timeFrame': '24 hours postoperative', 'description': 'Number of participants experienced nausea'}, {'measure': 'Change in preoperative well-being assessment from baseline to one hour using the 100 millimeter (mm) visual analogue scale', 'timeFrame': 'ist 24 hours postoperative', 'description': '100 mm visual analogue scales for hunger, thirst, anxiety, fatigue and nausea administered on the morning of surgery prior to morning beverage consumption and 60 minutes after the beverage. All measurements will be assessed using the same scale starting at 0 to 100mm with 0 being the worst and 100 being the best and average being 85.'}, {'measure': 'neonatal blood glucose concentration at four and ten hours of age', 'timeFrame': '24 hours post operative', 'description': 'measure neonatal blood glucose level at four and ten hours of age'}, {'measure': 'Neonates with plasma glucose level of less than 45 mg/dL between the groups', 'timeFrame': 'ist 24 hours postoperative', 'description': 'First umbilical cord blood sample will be taken for plasma glucose level of less than 45 mg/dL to note hypoglycemia between the groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enhanced recovery after surgery', 'Preoperative carbohydrate drink', 'cesarean section'], 'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.', 'detailedDescription': 'Carbohydrate (sugar-containing) nutritional supplements have become a routine part of the package of care for people undergoing planned surgical procedures. the investigator wanted to discover whether carbohydrate supplements are a useful part of care packages used by doctors to improve recovery after planned cesarean section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant female scheduled for elective cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women undergoing elective caesarean section\n* Term gestational age (37+0 to 41+6 weeks)\n* Singleton gestation\n\nExclusion Criteria:\n\n* Women with gestational diabetes and diabetes mellitus\n* Fetal intrauterine growth restriction\n* Ante-natally detected congenital anomaly which will require admission to the neonatal nursery\n* Women who received steroids within the past 7 days prior to delivery\n* Women who did not complete a gestational diabetes screening test'}, 'identificationModule': {'nctId': 'NCT03732404', 'briefTitle': 'Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Effects of Oral Preoperative Carbohydrate on Early Postoperative Outcome After Cesarean Section. A Double-Blind Placebo-controlled Study', 'orgStudyIdInfo': {'id': 'aswu/197/7/18'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preoperative carbohydrate loading', 'description': 'Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia', 'interventionNames': ['Drug: preoperative carbohydrate loading']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The control group will receive plain water with the same volume and timing of treatment', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'preoperative carbohydrate loading', 'type': 'DRUG', 'otherNames': ['Experimental'], 'description': 'Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia', 'armGroupLabels': ['preoperative carbohydrate loading']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo Comparator'], 'description': 'The control group will receive plain water with the same volume and timing of treatment.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'overallOfficials': [{'name': 'hany f sallam, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aswan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}