Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-28 @ 12:06 AM
Study NCT ID:
NCT04055194
Status:
UNKNOWN
Last Update Posted:
2019-08-13
First Post:
2019-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], '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': 'D010922', 'term': 'Placenta Diseases'}]}, '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Visually-identical drug and placebo tablets will be assigned to each participant using SNOSE congaing assignment code.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pregnant women with symptomatic placenta previa with previous bleeding attacks will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo till delivery. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-10', 'studyFirstSubmitDate': '2019-08-10', 'studyFirstSubmitQcDate': '2019-08-10', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of bleeding during antepartum bleeding attacks', 'timeFrame': '9 weeks GA', 'description': 'Amount of bleeding during antepartum bleeding attacks will be estimated by hemoglobin change from baseline at admission till delivery.'}], 'secondaryOutcomes': [{'measure': 'Number of women requiring antepartum blood transfusion', 'timeFrame': '9 weeks GA', 'description': 'Number of women requiring antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.'}, {'measure': 'Number of PRBCs units required during antepartum blood transfusion', 'timeFrame': '9 weeks GA', 'description': 'Number of PRBCs required during antepartum blood transfusion for resuscitation after severe antepartum hemorrhage.'}, {'measure': 'Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery', 'timeFrame': '9 weeks GA', 'description': 'Number of pregnant women experiencing severe antepartum hemorrhage necessitating urgent delivery'}, {'measure': 'Gestational age at delivery', 'timeFrame': '9 weeks GA', 'description': 'Gestational age in weeks at the time of delivery'}, {'measure': 'Neonatal intensive care unit (NICU) admission', 'timeFrame': '9 weeks', 'description': 'Number of neonates requiring NICU admission.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': '200 pregnant women with symptomatic placenta previa with previous bleeding attacks attending Ain Shams University maternity hospital will be recruited and randomized to receive either tranexamic acid tablets (500mg four times daily) or placebo. Amount of bleeding during antepartum bleeding attacks will be estimated (by hemoglobin change from baseline at admission till delivery).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gestational age 28 weeks of gestation.\n* Definite and reliable diagnosis of placenta previa (defined as presence of a placenta within 2 cm of the internal os), using transvaginal ultrasound scan.\n* Haemodynamically stable pregnant women.\n* Maternal age:20-40years old.\n* Pregnant women with placenta previa, and had previous bleeding attacks or admitted with antepartum haemorrhage.\n\nExclusion Criteria:\n\n* Multiple pregnancy.\n* Women with bleeding tendency due to any medical disorder (ITP, thrombocytopenia, coagulopathies),or on anticoagulants .\n* Severe antepartum hemorrhage and/or hemodynamic instability that necessitates urgent intervention and delivery.\n* Women have hypersensitivity or any contraindication to use of tranexamic acid.\n* Pregnant women with placenta previa with doppler showing morbidly adherent placenta.'}, 'identificationModule': {'nctId': 'NCT04055194', 'briefTitle': 'Antenatal Tranexamic Acid in Women With Symptomatic Placenta Previa', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy of Antenatal Tranexamic Acid in Pregnant Women With Symptomatic Placenta Previa in Decreasing Antepartum Hemorrhage - A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'AntenatalTRX-PP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic acid group', 'description': '100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.', 'interventionNames': ['Drug: Tranexamic acid tablets']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': '100 pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Tranexamic acid tablets', 'type': 'DRUG', 'otherNames': ['Kapron(R)'], 'description': 'Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.', 'armGroupLabels': ['Tranexamic acid group']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'state': 'Abbaseya', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Amal Ramadan, MBBCh', 'role': 'CONTACT', 'email': 'dr.amalramadan11@gmail.com', 'phone': '201098093525'}], 'facility': 'Ain SHams Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Amal Ramadan, MBBCh', 'role': 'CONTACT', 'email': 'dr.amalramadan11@gmail.com', 'phone': '+201098093525'}], 'overallOfficials': [{'name': 'Amal Ramadan, MBBCh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A Ramadan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical fellow of Obstetrics & Gynecology', 'investigatorFullName': 'Amal Ramadan', 'investigatorAffiliation': 'Ain Shams University'}}}}