Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-28 @ 7:09 AM
Study NCT ID:
NCT04707950
Status:
UNKNOWN
Last Update Posted:
2021-01-13
First Post:
2020-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid for the Prevention of Postpartum Haemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], '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': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be divided into two groups: a study group \\& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).\n\nThe second dose of TXA 1 g Intravenous can be given if:\n\n* Bleeding continues after 30 minutes\n* Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-11', 'studyFirstSubmitDate': '2020-02-25', 'studyFirstSubmitQcDate': '2021-01-11', 'lastUpdatePostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of blood loss', 'timeFrame': '30 minutes after baby delivery', 'description': '150 ml/pack'}], 'secondaryOutcomes': [{'measure': 'transfusion requirements', 'timeFrame': '7 days postpartum', 'description': 'number of women transfused blood'}, {'measure': 'additional medical intervention', 'timeFrame': '48 hours postpartum', 'description': 'number of patients were treated by an additional medical intervention'}, {'measure': 'additional surgical or radiological interventions to control bleeding', 'timeFrame': '7 days postpartum', 'description': 'number of patients were treated by additional surgical or radiological intervention'}, {'measure': 'Change in maternal hematocrit concentration', 'timeFrame': '48 hours postpartum', 'description': 'Hematocrit concentration (Percent)'}, {'measure': 'Tranexamic acid side effects', 'timeFrame': '24 hours postpartum', 'description': 'number of patients suffered from side effects'}, {'measure': 'thromboembolic events', 'timeFrame': '7 days postpartum', 'description': 'number of patients suffered from thromboembolic events'}, {'measure': 'Maternal death', 'timeFrame': '7 days postpartum', 'description': 'Number of women will die.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tranexamic acid', 'postpartum hemorrhage', 'cesarean section'], 'conditions': ['Postpartum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Use of tranexamic acid (TXA) for the prevention of postpartum haemorrhage (PPH) after cesarean section in high-risk patients ( a randomized control trial ).', 'detailedDescription': 'Participants will be divided into two groups: a study group \\& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).\n\nThe second dose of TXA 1 g Intravenous can be given if:\n\n* Bleeding continues after 30 minutes\n* Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess efficacy of TXA in prevention of PPH and reduction of intra and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'women with high risk for postpsrtum hemorrhage after ceserean section', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nScheduled or unscheduled cesarean delivery. Singleton or twin gestation.\n\nWomen at high risk for PPH after cesarean section:\n\nPlacenta previa, accreta, increta or percreta. haematocrit (HCT) \\< 30%. Bleeding at admission. History of Postpartum haemorrhage. Abnormal vital signs (hypotension or tachycardia). Previous Cesarean or uterine surgery. More than four previous deliveries. Multiple Gestation. Large Uterine fibroids. Chorioamnionitis. Magnesium sulphate use. Prolonged use of oxytocin.\n\nExclusion Criteria:\n\n1. Age less than 18 years.\n2. Women who are not at high risk for PPH.\n3. Women attending for normal vaginal delivery.\n4. Pre-existing maternal hemorrhagic conditions such as Factor 8 deficiency - haemophilia A carrier, Factor 9 deficiency - haemophilia B carrier or Von Willebrand's disease.\n5. Recent diagnosis or history of venous thromboembolism or arterial thrombosis because TXA is a risk factor for thromboembolism, and its use is contraindicated.\n6. Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome, because of the increased risk of thrombosis.\n7. Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease because of hypercoagulability and the increased risk of thrombosis or thromboembolism\n8. Need for a therapeutic dose of anticoagulation before delivery, because the risk of thrombosis may be increased with TXA.\n9. Hypersensitivity to TXA or any of its ingredients.\n10. Transfusion or planned transfusion of any blood products during the current admission because the primary outcome is already pre-determined and the need for transfusion will be unrelated to perioperative haemorrhage\n11. Seizure disorder (including eclampsia), and its use has been associated with postoperative seizures..\n12. Active cancer, because of the risk of thromboembolism.\n13. Congestive heart failure requiring treatment, because of the risk of thrombosis.\n14. If there is no haemoglobin and hematocrit result available from the last 4 weeks since it is necessary to measure the postoperative change in haemoglobin and hematocrit."}, 'identificationModule': {'nctId': 'NCT04707950', 'briefTitle': 'Tranexamic Acid for the Prevention of Postpartum Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Use of Tranexamic Acid for the Prevention of Postpartum Haemorrhage After Cesarean Section in High-risk Patients ( a Randomized Control Trial ).', 'orgStudyIdInfo': {'id': 'SEAbdelfattah'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'study group will be given tranexamic acid', 'description': 'Participants will be divided into two groups: a study group \\& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).\n\nThe second dose of TXA 1 g Intravenous can be given if:\n\n* Bleeding continues after 30 minutes\n* Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).', 'interventionNames': ['Drug: Tranexamic Acid 100 milligram/Milliliter', 'Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'The control group will not be given Tranexamic acid but only the standard management ( Oxytocin )', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Tranexamic Acid 100 milligram/Milliliter', 'type': 'DRUG', 'otherNames': ['Study group'], 'description': 'Participants will be divided into two groups: a study group \\& a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).\n\nThe second dose of TXA 1 g Intravenous can be given if:\n\n* Bleeding continues after 30 minutes\n* Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements).', 'armGroupLabels': ['study group will be given tranexamic acid']}, {'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Control group'], 'description': 'both groups will be given oxytocin as a standard management', 'armGroupLabels': ['Control group', 'study group will be given tranexamic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'Banha', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed A Morad, MD', 'role': 'CONTACT', 'email': 'awalid217@yahoo.com', 'phone': '0201224214435'}, {'name': 'Aboubakr M Elnashar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ahmed A Walid Anwar, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ehab E Barakat, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Benha university hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}, {'zip': '13511', 'city': 'Banhā', 'state': 'Banha', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Egypt', 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'centralContacts': [{'name': 'Ahmed A Morad, MD', 'role': 'CONTACT', 'email': 'awalid217@yahoo.com', 'phone': '0201224214435'}, {'name': 'Abubaker M Elnashar, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Abubaker M Elnashar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha Faculty of Medecine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dr. Abou Bakr Mohamed El Nashaar', 'investigatorAffiliation': 'Benha University'}}}}