Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2026-03-02 @ 3:45 PM
Study NCT ID:
NCT02936661
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2016-10-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2016-10-15', 'studyFirstSubmitQcDate': '2016-10-17', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postpartum hemorrhage', 'timeFrame': '24h after the cesarean section'}], 'secondaryOutcomes': [{'measure': 'the amount of postpartum bleeding', 'timeFrame': '24h after the cesarean section'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postpartum hemorrhage， cesarean section， tranexamic acid'], 'conditions': ['Postpartum Hemorrhage， Cesarean Section']}, 'descriptionModule': {'briefSummary': 'It is a multicenter randomized, double-blind and placebo-controlled trial. Totally 6500 women to delivery by cesarean section will be recruited in this study. In addition to routinely oxytocin, the women in study group will receive TXA 1 g in 2 minutes after they delivered their babies, and those in control group will receive placebo. The incidence of postpartum hemorrhage, the amount of bleeding, as well as the side effects will be observed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gestational week more than 37;\n* to delivery by cesarean section;\n* informed consent form signed\n\nExclusion Criteria:\n\n* Any known renal or liver disorders\n* History of venous or arterial thrombosis\n* Any disease or history tend to increase thrombosis: opertion in 1 month; active smoker.\n* Do cesarean section because of active bleeding'}, 'identificationModule': {'nctId': 'NCT02936661', 'briefTitle': 'Tranexamic Acid for Preventing Postpartum Hemorrhage After Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'orgStudyIdInfo': {'id': 'ShanghaiFMIH-TXA1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tranexamic acid', 'description': 'Tranexamic acid 1 g（10ml） IV in 2 minutes after the baby delivered during ceasarean section', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'NS 10ml IV in 2 minutes after the baby delivered during ceasarean section', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'armGroupLabels': ['Tranexamic acid']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}