Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2026-01-02 @ 7:34 AM
Study NCT ID:
NCT05273632
Status:
COMPLETED
Last Update Posted:
2023-02-08
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D019106', 'term': 'Postoperative Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}, {'id': 'D011183', 'term': 'Postoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D004979', 'term': 'Ethamsylate'}], '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': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-05', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'blood loss during and after cesarean delivery', 'timeFrame': 'First 2 hours after C-Section', 'description': 'Measuring of Hemoglobin level and Hematocrit level pre and post operatively.'}], 'secondaryOutcomes': [{'measure': 'post operative bleeding', 'timeFrame': 'first 24 hours after C-Section', 'description': 'assessment of Hemoglobin level and Hematocrit level post operatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood loss', 'cesarean section', 'oxytocin', 'tranexamic acid', 'etamsylate', 'saline', 'Intra-operative', 'Postoperative'], 'conditions': ['Blood Loss, Surgical', 'Blood Loss, Postoperative']}, 'descriptionModule': {'briefSummary': 'Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline as Pre-operative Administration.', 'detailedDescription': 'Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Normal Saline to reduce intra operative bleeding and postoperative bleeding during elective Cesarean Delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant females admitted for Elective Cesarean Section.\n* Gestational age of pregnancy (38 weeks To 40 weeks).\n* the average height of 145 to 160 cm,average body weight of 45 to 85 kgs.\n* Singleton living fetus.\n* No medical disorders.\n* Informed Oral Consent From The Patient.\n\nExclusion Criteria:\n\n* Severe medical and surgical disorders as thyroid dysfunction, which was excluded by routine thyroid function test (free T3, free T4, and thyroid stimulating hormone(TSH), all of them should be within normal limits).\n* Bleeding tendency, for example, disseminated intravascular coagulopathy, which was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).\n* Acute liver or kidney diseases; blood disorders, such as anaemia.\n* Allergy to Tranexamic acid.\n* Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum haemorrhage.\n* Ante partum Hemorrhage such placental abruption.'}, 'identificationModule': {'nctId': 'NCT05273632', 'briefTitle': 'Comparison Study of Oxytocin Versus Tranexamic Acid and Etamsylaye Versus Placebo(Saline)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egymedicalpedia'}, 'officialTitle': 'Comparison Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate Versus Placebo to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section', 'orgStudyIdInfo': {'id': 'EL-SAYED EL-DESOUKY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin', 'description': 'Pre- Operative Oxytocin is given intravenously 5-10 minutes slowly before skin incision', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid and Etamsylate', 'description': 'Tranexamic acid and Etamsylate are slowly given intravenously 10 minutes before start of Cesarean Delivery', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline', 'description': 'Normal saline (about 200 ml) is given intravenously 10 minutes before start of Cesarean Section', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Tranexamic acid and Etamsylate'], 'description': 'trial of reduction of losing blood intra operative or post operative during Cesarean Delivery', 'armGroupLabels': ['Oxytocin', 'Saline', 'Tranexamic acid and Etamsylate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Sayed Galal Hospital, Alhusein Hospital, Alzahraa Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egymedicalpedia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}