Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-31 @ 2:52 AM
Study NCT ID:
NCT05434533
Status:
COMPLETED
Last Update Posted:
2023-02-21
First Post:
2022-06-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000249', 'term': 'Adenosine Monophosphate'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000227', 'term': 'Adenine Nucleotides'}, {'id': 'D011685', 'term': 'Purine Nucleotides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-17', 'studyFirstSubmitDate': '2022-06-09', 'studyFirstSubmitQcDate': '2022-06-26', 'lastUpdatePostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction of blood loss during C-section.', 'timeFrame': '1 hour', 'description': 'ml'}, {'measure': 'Prevention of 1ry postpartum hemorrhage.', 'timeFrame': '24 hours', 'description': 'ml'}], 'secondaryOutcomes': [{'measure': 'Reduction of hospital stay.', 'timeFrame': '48 hours', 'description': 'Number of days'}, {'measure': 'Decrease risk of maternal blood transfusion', 'timeFrame': '48 hours', 'description': 'Number of blood products units'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high risk pregnancy', 'cesarean section.', 'tranexamic acid'], 'conditions': ['High Risk Pregnant Women Undergoing Elective Cesarean Section']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the prophylactic role of tranexamic acid in reducing blood loss during and after elective cesarean section delivery in high risk patients.\n\nComparing effect of administration of 1gm of TXA half an hour before elective C-section , effect of administration of 1gm of TXA on the start of uterine incision and placebo effect, Where in all an addition of prophylactic uterotonics is given, in a randomized control, double blind trial of 3 groups.', 'detailedDescription': "All patients will undergo the following\n\nI. History : Medical history, Obstetric history, Comorbidities, Allergies. II. Clinically: Vital signs, Abdomino-pelvic examination, per-vaginal examination.\n\nIII. Laboratory: Hemoglobin, Hematocrit before \\& after cesarean section. IV. Routine Ultrasound. V. Cesarean section: done under spinal anathesia.\n\nVI. Calculation of blood loss:\n\nThe quantity of blood loss (ml) is calculated from 3 components :\n\n* (weight of used towels during surgery - weight of used towels prior to surgery),plus\n* (volume of blood sucked in suction container after placental delivery) ,plus\n* (weight of used vaginal pad in the first 2 hours after CS - the pad' s dry weight)\n* Each 1 mg increase the weight of either the towels or the vaginal pads is equivalent to 1 ml blood loss (Vitello, Dominic J., et al).\n\nVII. Informed Consent: will be obtained from all participants including the pregnant women who are included in the study .\n\nAll patients will receive routine ecbolics ( oxytocin ) after delivery of baby."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* High risk women undergoing elective C-section\n\n * Hypertensive patients.\n * Obese patients.\n * Patients on LMWH.\n * Transverse lie\n * DM ( Type 1 \\& Gestational )\n * Cardiac ( Not on Anticoagulants )\n * Placenta Previa ( Not in PAS )\n * Previous uterine scar ( \\> previous 2 C- section )\n\nExclusion Criteria:\n\n* Patients with bleeding tendency.\n* HELLP Syndrome.\n* Emergency C- section.\n* Mechanical prosthetic valve\n* Atrial Fibrillation.\n* Allery to tranexamic acid\n* Placenta Accreta , Increta , percreata.'}, 'identificationModule': {'nctId': 'NCT05434533', 'briefTitle': 'The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'The Prophylactic Role of Tranexamic Acid in High Risk Pregnant Women Undergoing Elective Cesarean Section in Prevention of Postpartum Hemorrhage', 'orgStudyIdInfo': {'id': 'FarahMSc2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'preoperative', 'description': '1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) 30 mins before the operation', 'interventionNames': ['Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)']}, {'type': 'EXPERIMENTAL', 'label': 'uterine incision', 'description': '1 gm of Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml) directly before uterine incision', 'interventionNames': ['Drug: Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)']}, {'type': 'NO_INTERVENTION', 'label': 'placebo', 'description': '1ml of normal saline will be given'}], 'interventions': [{'name': 'Tranexamic acid (Kapron, Amoun Pharmaceuticals SAE, Egypt. 5ml Amp, 100mg /1ml)', 'type': 'DRUG', 'description': 'IV 1gm', 'armGroupLabels': ['preoperative', 'uterine incision']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ayman Hany, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ayman Hany, MD', 'investigatorAffiliation': 'Cairo University'}}}}