Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-26 @ 12:43 AM
Study NCT ID:
NCT05072860
Status:
UNKNOWN
Last Update Posted:
2021-10-11
First Post:
2021-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'a double-blinded randomized controlled trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a double-blinded randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-29', 'studyFirstSubmitDate': '2021-09-29', 'studyFirstSubmitQcDate': '2021-09-29', 'lastUpdatePostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative blood loss', 'timeFrame': '30 minutes', 'description': 'measures the intraoperative blood loss by direct and gravimetric methods'}], 'secondaryOutcomes': [{'measure': 'need of blood transfusion', 'timeFrame': '12 hours', 'description': 'number of unites of blood transfusion'}, {'measure': 'need of uterotonic', 'timeFrame': '24 hours', 'description': 'misoprostol, oxytocin etc'}, {'measure': 'change in hemoglobin', 'timeFrame': '24 hours', 'description': 'change in hemoglobin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'In hypertensive women having an elective cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.', 'detailedDescription': 'patients were allocated to one of two groups after induction of anesthesia. they received temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'hypertensive women undergoing elective cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hypertensive women undergoing elective cesarean section\n\nExclusion Criteria:\n\n* Patients with cardiac, hepatic, renal, or thromboembolic disease. ,\n* patients with the high possibility of the morbid adherent placenta,\n* known coagulopathy and\n* those presented with severe antepartum hemorrhage\n* refuse to participate'}, 'identificationModule': {'nctId': 'NCT05072860', 'briefTitle': 'Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women Undergoing Elective Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Hypertensive Women Undergoing Elective Cesarean Section: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'aswu/542/7/21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Topical tranexamic acid', 'description': 'temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid or placebo', 'interventionNames': ['Drug: Topical tranexamic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': 'temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid', 'interventionNames': ['Other: : normal saline']}], 'interventions': [{'name': 'Topical tranexamic acid', 'type': 'DRUG', 'otherNames': ['experimental'], 'description': 'temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid', 'armGroupLabels': ['Topical tranexamic acid']}, {'name': ': normal saline', 'type': 'OTHER', 'otherNames': ['Placebo Comparator'], 'description': 'temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid', 'armGroupLabels': ['normal saline']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'A Professor', 'investigatorFullName': 'hany farouk', 'investigatorAffiliation': 'Aswan University Hospital'}}}}