Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-29 @ 4:17 PM
Study NCT ID:
NCT06515535
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-23
First Post:
2024-07-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010922', 'term': 'Placenta Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-24', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-07-17', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of blood loss', 'timeFrame': 'during operation', 'description': 'amount of intraoperative blood loss during CS in patients with placenta previa'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'during operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.\n\nPatients will be randomly assigned into two groups:\n\nGroup (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.\n\nGroup (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-40 years old.\n* BMI less than 30 kg/m2.\n* Pregnancy of singleton living fetus.\n* Placenta previa by ultrasound assessment\n* Gestational age \\> 36 weeks.\n\nExclusion Criteria:\n\n* Women with a history of any medical disorder with pregnancy, e.g., Gestational diabetes and hypertension.\n* Women with systemic diseases, e.g., diabetes mellites, systemic immune disorders such as systemic lupus erythematosus\n* Women with bleeding tendency or coagulopathy.\n* Women on anticoagulants or hemodynamically unstable women.\n* Women with uterine abnormalities, such as fibroids or polyps.\n* Emergency termination of pregnancy.\n* Intrauterine fetal death.\n* Pregnancy with obstetric hemorrhage, e.g., antepartum hemorrhage\n* Cases of placenta accrete spectrum disorder or placental abruption\n* Women with known allergies to Tranexamic acid'}, 'identificationModule': {'nctId': 'NCT06515535', 'briefTitle': 'Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During Elective Cesarean Delivery in Patients With Placenta Previa', 'orgStudyIdInfo': {'id': 'MS-201-2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group (n=28)', 'description': 'The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.', 'interventionNames': ['Drug: Topical tranexamic acid', 'Drug: Intravenous tranexamic acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group (n=28)', 'description': 'The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.', 'interventionNames': ['Drug: Intravenous tranexamic acid']}], 'interventions': [{'name': 'Topical tranexamic acid', 'type': 'DRUG', 'description': 'Topical tranexamic acid will be applied after placental delivery on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%', 'armGroupLabels': ['Study group (n=28)']}, {'name': 'Intravenous tranexamic acid', 'type': 'DRUG', 'description': 'Intravenous tranexamic acid will be given in the form of an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.', 'armGroupLabels': ['Control group (n=28)', 'Study group (n=28)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of obgyn Cairo university', 'investigatorFullName': 'Abdalla Mousa', 'investigatorAffiliation': 'Cairo University'}}}}