Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-29 @ 11:54 PM
Study NCT ID:
NCT07335432
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-01-13
First Post:
2026-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RCT - Efficacy of Intravenous Vitamin C Versus Placebo on Estimated Blood Loss in Total Abdominal Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}, {'id': 'D062788', 'term': 'Adenomyosis'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2026-01-05', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative estimate blood loss', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vitamin C', 'Total abdominal hysterectomy', 'Blood loss'], 'conditions': ['Myoma;Uterus', 'Adenomyosis of Uterus']}, 'descriptionModule': {'briefSummary': 'Intervention Group: Received two 1 gm doses of Vitamin C intravenously (IV). first Dose: At midnight on the day of surgery. Second Dose: Immediately after the surgical incision. Control Group: Received two doses of a normal saline intravenously (IV) at the exact same times.\n\nThe primary outcome was to compare intraoperative blood loss between patients who received intravenous Vitamin C and those who did not, following an abdominal hysterectomy under general anesthesia.\n\nIntraoperative estimated blood loss (EBL) was meticulously quantified by weighing surgical gauze and measuring suction canister volumes.\n\nThe secondary outcomes were to evaluate the potential benefits of Vitamin C administration, including:\n\n* Reduction in the decline of hematocrit levels after surgery.\n* Reduction of the length of hospital stay'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female patients who underwent total abdominal hysterectomy\n\n * No bleeding tendency.\n * No history of anticoagulant or thrombolytic drug use\n * No contraindications to vitamin C supplementation\n\nExclusion Criteria:\n\n* Inability to communicate in the Thai language.\n\n * Underwent total abdominal hysterectomy due to gynecologic malignancy.\n * Required emergency total abdominal hysterectomy.\n * History of vitamin C supplementation within 2 weeks prior to surgery.\n * History of smoking.\n * Previous abdominal surgery, such as bowel surgery, cesarean section'}, 'identificationModule': {'nctId': 'NCT07335432', 'acronym': 'Vit C in TAH', 'briefTitle': 'RCT - Efficacy of Intravenous Vitamin C Versus Placebo on Estimated Blood Loss in Total Abdominal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Queen Savang Vadhana Memorial Hospital, Thailand'}, 'officialTitle': 'Efficacy of Intravenous Vitamin C Versus Placebo on Estimated Blood Loss in Total Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': '012/2567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Vitamin C', 'description': 'Intervention Group: Received two 1 gm doses of Vitamin C intravenously (IV). first Dose: At midnight on the day of surgery. Second Dose: Immediately after the surgical incision. Control Group: Received two doses of a normal saline intravenously (IV) at the exact same times.', 'interventionNames': ['Dietary Supplement: Vitamin C (Ascorbic Acid)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Vitamin C (Ascorbic Acid)']}], 'interventions': [{'name': 'Vitamin C (Ascorbic Acid)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Received two 1 gm doses of Vitamin C intravenously (IV).\n\nfirst Dose: At midnight on the day of surgery.\n\nSecond Dose: Immediately after the surgical incision.', 'armGroupLabels': ['Experimental: Vitamin C', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20110', 'city': 'Si Racha', 'state': 'Changwat Chon Buri', 'country': 'Thailand', 'facility': 'Queen Savang Vadhana Memorial hospital', 'geoPoint': {'lat': 13.17372, 'lon': 100.93111}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data was save in form of microsoft excel spreadsheet and SPSS file'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Savang Vadhana Memorial Hospital, Thailand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Aektanat Tawornkitpanich', 'investigatorAffiliation': 'Queen Savang Vadhana Memorial Hospital, Thailand'}}}}