Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-25 @ 10:55 PM
Study NCT ID:
NCT04656067
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2020-11-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate
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': 'D004979', 'term': 'Ethamsylate'}, {'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2020-11-26', 'studyFirstSubmitQcDate': '2020-11-30', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative and Post operative bleeding(defined as blood loss ≥500 cc)', 'timeFrame': 'First 2 hours after C-Section', 'description': 'Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level pre and post operatively.'}], 'secondaryOutcomes': [{'measure': 'Sever PPH as bleeding is >1000 cc', 'timeFrame': 'first 24 hours after C-Section', 'description': 'Outcome of the study will be measured in terms of 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(Kapron)', 'Etamsylate(Dicynon).'], 'conditions': ['Blood Loss, Surgical', 'Blood Loss, Postoperative']}, 'descriptionModule': {'briefSummary': 'Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate, Pre-operative Administration.', 'detailedDescription': 'Caesarean Delivery commonly referred to as caesarean section and occasionally caesarean birth is defined as the delivery of a foetus(es) through surgical incisions made through the anterior abdominal wall (technically referred to as laparotomy) and the anterior uterine wall (technically denoted to as hysterotomy).\n\nObstetric Hemorrhage (Intra operative OR post operative bleeding)is still the major cause of maternal morbidity and mortality worldwide contributing to nearly 25% of direct maternal deaths. And accounts for 50% of maternal mortality in low-income countries.\n\nSo many Strategies reducing the intraoperative blood loss or post operative blood loss could be helpful in decreasing the risks of blood transfusion and the postoperative maternal morbidity.\n\nSo these Medications are such as Oxytocin, Carbetocin, Misoprostol, Prostaglandin F2 alpha, methylergonovine, Tranexamic acid and Etamsylate . have been tried before to control bleeding during and after Cesarean Section.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pregnant females admitted for elective Cesarean Section.\n2. Gestational age (38 to 41 weeks).\n3. Age of the participants: 20 to 40 years.\n4. Body Mass Index (18.5 - 29.9).\n5. Singleton living fetus.\n6. No medical disorders.\n7. Informed written consent from the candidates.\n\nExclusion criteria:\n\n1. \\- 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).\n2. -Bleeding tendency, was excluded by platelet count, coagulation time, bleeding time, prothrombin time, partial thromboplastin time, and thrombin time (all should be within normal).\n3. -Acute and chronic liver or kidney diseases; blood disorders, such as anemia.\n4. -Allergy to Tranexamic acid or any drug used.\n5. -Risk factors for PPH, such as polyhydramnios, fetal macrosomia, antepartum hemorrhage.\n6. \\- Abnormal placentae such as placenta previa and placental abruption.\n7. -Pregnancy complications such as severe pre-eclampsia, Gestational HTN, Gestational DM, and multi Fetal pregnancies, those requiring blood transfusion.\n8. \\- Patients who refused spinal anesthesia.'}, 'identificationModule': {'nctId': 'NCT04656067', 'briefTitle': 'Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egymedicalpedia'}, 'officialTitle': 'Comparative Study Between Oxytocin Versus Tranexamic Acid and Ethamsylate to Reduce Blood Loss Intraoperative and Post Operative During Elective Cesarean Section', 'orgStudyIdInfo': {'id': 'DR,ABDELAZIM SOBHI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin(only)', 'description': 'oxytocin is given IV infusion 5-10 minutes before the start of skin incision in the Elective Cesarean Section', 'interventionNames': ['Drug: Oxytocin ,Tranexamic acid and Ethamsylate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid and Ethamsylate', 'description': 'Tranexamic acid and Ethamsylate are given IV slowly 5-10 minutes before the start of skin incision in the Elective Cesarean Section', 'interventionNames': ['Drug: Oxytocin ,Tranexamic acid and Ethamsylate']}], 'interventions': [{'name': 'Oxytocin ,Tranexamic acid and Ethamsylate', 'type': 'DRUG', 'otherNames': ['Syntocinon , Kapron', 'Dicynon'], 'description': 'Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate', 'armGroupLabels': ['Oxytocin(only)', 'Tranexamic acid and Ethamsylate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Sayed Galal Hospital and Shoubra General Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dr.,AbdelSattar M Farhan, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University, Faculty of medicine for boys'}, {'name': 'Dr.,ElSayed A. ElDesouky, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University, Faculty of medicine for boys'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Etamsylate .'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egymedicalpedia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant specialist', 'investigatorFullName': 'DR.ABDELAZIM', 'investigatorAffiliation': 'Egymedicalpedia'}}}}