Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2025-12-24 @ 4:35 PM
Study NCT ID:
NCT04463966
Status:
UNKNOWN
Last Update Posted:
2020-07-09
First Post:
2020-04-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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': '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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-08', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood loss', 'timeFrame': 'immediately after deliver', 'description': 'Estimation of blood loss'}], 'secondaryOutcomes': [{'measure': 'blood pressure', 'timeFrame': 'immediately after delivery', 'description': 'blood pressure'}, {'measure': 'pulse', 'timeFrame': 'immediately after delivery', 'description': 'pulse'}, {'measure': 'temperature', 'timeFrame': 'immeditely after delivery', 'description': 'temperature'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tranexamic acid', 'postpartum hemorrhage', 'cesarean section'], 'conditions': ['Post Partum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Use of Tranexamic Acid for prevention of Postpartum hemorrhage in high risk patients: Randomized Control Trial', 'detailedDescription': 'This study aims to assess the efficacy of administration of Tranexamic Acid in preventing Postpartum haemorrhage \\& reducing intraoperative and postoperative blood loss in high risk women for Postpartum Hemorrhage undergoing caesarean section. Studying its benefit to transfusion-sparing and hysterectomy-sparing. \\& reduction of hemorrhage-related mortality when Postpartum hemorrhage is expected.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women at high risk for postpartum hemorrhage after cesarean section\n\nExclusion Criteria:\n\n* women who are not at high risk for postpartum hemorrhage , or attending for normal vaginal delivery.'}, 'identificationModule': {'nctId': 'NCT04463966', 'briefTitle': 'Prevention of Postpartum Haemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Tranexamic Acid for the Prevention of Postpartum Haemorrhage', 'orgStudyIdInfo': {'id': 'Tranexamic'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study', 'description': 'Tranexamic acid 1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .', 'interventionNames': ['Drug: Tranexamic acid injection']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'control group will not be given tranexamic acid'}], 'interventions': [{'name': 'Tranexamic acid injection', 'type': 'DRUG', 'otherNames': ['Kapron, 500 mg/5ml'], 'description': '1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .', 'armGroupLabels': ['Study']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Shaimaa ezzat', 'role': 'CONTACT', 'phone': '00201009023289'}], 'facility': 'Police Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Aboubakr Elnashar, MD', 'role': 'CONTACT', 'email': 'elnashar53@hotmail.com', 'phone': '00201066934749'}, {'name': 'shaimaa ezzat', 'role': 'CONTACT', 'phone': '00201009023289'}], 'overallOfficials': [{'name': 'Shaimaa Ezzat', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Police Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Dr. Abou Bakr Mohamed El Nashaar', 'investigatorAffiliation': 'Benha University'}}}}