Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-19 @ 7:59 AM
Study NCT ID:
NCT05494268
Status:
COMPLETED
Last Update Posted:
2022-12-19
First Post:
2022-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000098987', 'term': 'Fetus-in-Fetu'}], 'ancestors': [{'id': 'D014428', 'term': 'Twins, Conjoined'}, {'id': 'D009008', 'term': 'Abnormalities, Severe Teratoid'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2022-08-06', 'studyFirstSubmitQcDate': '2022-08-06', 'lastUpdatePostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The comparison of the changes in thiol disulfide values between the groups', 'timeFrame': 'From beginning to two hours after the surgery', 'description': 'The native thiol, total thiol, disulfide, native thiol/total thiol ratio, disulfide/native thiol ratio, and disulfide/total thiol ratio will be determined.'}], 'secondaryOutcomes': [{'measure': 'Incidence of intraoperative hypotension', 'timeFrame': 'From beginning to the end of the surgery', 'description': 'Hypotension is defined as a decrease in the mean arterial pressure by ˃20% of the baseline value.'}, {'measure': 'Total ephedrine usage', 'timeFrame': 'From beginning to the end of the surgery', 'description': 'At hypotensive episodes, 5 mg ephedrine will be used intravenously.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy Related', 'Cesarean Delivery Affecting Fetus', 'Fetus Fetus']}, 'descriptionModule': {'briefSummary': 'The primary aim of this randomised control trial is to assess the impact of pre-operative carbohydrate loading on thiol disulfide homeostasis when compared to standard care in elective cesarean section. Half of the participants will receive pre-operative carbohydrates and the other half will receive standard care.', 'detailedDescription': 'The concept of enhanced recovery after surgery (ERAS) has been gradually extended from surgery to the field of obstetrics. Carbohydrate loading before the surgery in obstetric patients reduce the incidence of nausea and vomiting and reduce insulin resistance. Although these effects of the preoperative carbohydrate loading has been studied, the thiol disulfide homeostasis effects after carbohydrate loading has not been investigated yet. Thiol-disulfide homeostasis (TDH) plays a critical role in the mechanisms of antioxidant defense, detoxification, apoptosis, regulation of enzyme activities, transcription, and cellular signal transduction. Since the newborns are very susceptible to harmfull effects of reactive oxygen species, the effect of carbohydrate loading on the reactive oxygen species gain importance.\n\nAll mothers undergoing a planned caesarean section in the Karaman Training and Research Hospital will be invited to participate. Mothers will be divided into two groups. One group will receive standard care and the other group will receive a carbohydrate drink in addition to standard care.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The term pregnant patients admitted to Karaman Training and Research Hospital', 'genderDescription': 'only pregnant patients will be studies.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term pregnancies,\n* Planned elective ceserean sections,\n* Under spinal anesthesia,\n* Pregnants who can read and write Turkish.\n\nExclusion Criteria:\n\n* Preterm pregnants,\n* Pregnants with reflux,\n* obesity,\n* hiatus hernia,\n* ileus,\n* enteral nutrition,\n* alcohol or substance abuse,\n* prolonged delivery,\n* systemic chronic diseases,\n* malignancy,\n* GDM,eclampsia,preeclampsia,\n* fetal anomaliy,\n* prolonged delivery'}, 'identificationModule': {'nctId': 'NCT05494268', 'briefTitle': 'Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis', 'organization': {'class': 'OTHER', 'fullName': 'Karamanoğlu Mehmetbey University'}, 'officialTitle': 'Effects of Preoperative Oral Carbohydrate Loading on Maternal Thiol-disulfide Homeostasis', 'orgStudyIdInfo': {'id': 'KaramanogluMehmeybeyU'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experimental ( Carb Group)', 'description': 'Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery.', 'interventionNames': ['Drug: Carbohydrate']}, {'label': 'Standart Care (Non-carb Group)', 'description': 'Preoperative education will be provided by researchers to the patients on the ward before fluid intake. Solid food will be forbidden starting at 20:00 p.m, and drinking will be forbidden after 22:00 p.m the day before surgery. The Carb Group will consume carbohdrate fluid and Non-carb Group will consume equal amount of water at night and two hours before the surgery.'}], 'interventions': [{'name': 'Carbohydrate', 'type': 'DRUG', 'description': 'Preoperative Carbohydrate Loading Drink', 'armGroupLabels': ['Experimental ( Carb Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Karaman', 'state': 'Merkez', 'country': 'Turkey (Türkiye)', 'facility': 'Karaman Training and Research Hospital', 'geoPoint': {'lat': 37.18111, 'lon': 33.215}}], 'overallOfficials': [{'name': 'Ozlem Dulger, Assist Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karaman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'All the results of the study will be shared on request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karamanoğlu Mehmetbey University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist Prof', 'investigatorFullName': 'Ozlem Dulger', 'investigatorAffiliation': 'Karamanoğlu Mehmetbey University'}}}}