Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 7:55 AM
Study NCT ID:
NCT04651166
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2020-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004108', 'term': 'Dilatation, Pathologic'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, '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'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-31', 'studyFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intervention to control blood loss', 'timeFrame': 'At time of procedure', 'description': 'Rate at which providers perform interventions to control blood loss during D\\&E procedures'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abortion', 'Dilation and Evacuation', 'Hemorrhage', 'Blood Loss']}, 'descriptionModule': {'briefSummary': 'Prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (D\\&E). We propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (IV) tranexamic acid will decrease the need for interventions to control bleeding at the time of D\\&E at 16 to 24 weeks gestation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requesting pregnancy termination\n* Intrauterine pregnancy at 16 to 24 weeks gestation\n* Participants must be willing and capable of giving informed consent and able to understand and sign written consents in English.\n\nExclusion Criteria:\n\n* History of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)'}, 'identificationModule': {'nctId': 'NCT04651166', 'briefTitle': 'Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation', 'organization': {'class': 'OTHER', 'fullName': 'University of Hawaii'}, 'officialTitle': 'Effect of Prophylactic Tranexamic Acid on Bleeding Outcomes for Dilation and Evacuation', 'orgStudyIdInfo': {'id': 'RA-2020-050'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '100mL saline or lactated ringer without tranexamic acid added given intravenously over 10 minutes at start of procedure', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator', 'description': '1g tranexamic acid mixed in 100mL saline or lactated ringer given intravenously over 10 minutes at start of procedure', 'interventionNames': ['Drug: Tranexamic acid']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'description': '1g tranexamic acid mixed in 100mL saline or lactated ringer', 'armGroupLabels': ['Active Comparator']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '100mL saline or lactated ringers', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Queens Medical Center', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}], 'overallOfficials': [{'name': 'Marit Pearlman Shapiro', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hawaii'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hawaii', 'class': 'OTHER'}, 'collaborators': [{'name': 'Society of Family Planning', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Complex Family Planning Fellow', 'investigatorFullName': 'Marit Pearlman Shapiro', 'investigatorAffiliation': 'University of Hawaii'}}}}