Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 7:20 PM
Study NCT ID:
NCT04549012
Status:
UNKNOWN
Last Update Posted:
2020-09-16
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination of Blood Loss After CS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'women will be given serial number ,randomization will be done through a computer generated system'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group (A) will receive oxytocin only Group (B)will receive oxytocin plus tranexamic acid'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2020-09-09', 'studyFirstSubmitQcDate': '2020-09-14', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of blood loss', 'timeFrame': 'baseline', 'description': 'comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS'}], 'secondaryOutcomes': [{'measure': 'maternal and neonatal complication', 'timeFrame': 'baseline', 'description': 'blood transfusion ,surgical injuries ,'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Drug']}, 'descriptionModule': {'briefSummary': 'Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS', 'detailedDescription': 'tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age : 20-40 year\n\n * 2- Gestational age is between 37-41weeks\n\n3- Delivery by uncomplicated elective CS\n\nExclusion Criteria:\n\n* 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),'}, 'identificationModule': {'nctId': 'NCT04549012', 'briefTitle': 'Determination of Blood Loss After CS', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section', 'orgStudyIdInfo': {'id': 'blood loss after CS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group A', 'description': 'will receive oxytocin', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'will receive tranexamic acid plus oxytocin', 'interventionNames': ['Drug: Tranexamic acid']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'otherNames': ['oxytocin'], 'description': 'comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS', 'armGroupLabels': ['group B']}, {'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Oxytocin', 'armGroupLabels': ['group A']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'noha abu shata', 'role': 'CONTACT', 'email': 'mhmwdnhy44@gmail.com', 'phone': '01000287839'}, {'name': 'tamer Borg', 'role': 'CONTACT', 'email': 'tamerborg1975@gmail.com', 'phone': '01001457437'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'egypt', 'investigatorFullName': 'Noha Mahmoud Abu Shata', 'investigatorAffiliation': 'Ain Shams University'}}}}