Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-28 @ 6:29 AM
Study NCT ID:
NCT04733157
Status:
COMPLETED
Last Update Posted:
2023-03-20
First Post:
2021-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], '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': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chipo.gwanzura@gmail.com', 'phone': '+263774718381', 'title': 'Dr. Chipo Gwanzura', 'organization': 'University of Zimbabwe'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 week', 'eventGroups': [{'id': 'EG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section', 'otherNumAtRisk': 611, 'deathsNumAtRisk': 611, 'otherNumAffected': 50, 'seriousNumAtRisk': 611, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group', 'otherNumAtRisk': 613, 'deathsNumAtRisk': 613, 'otherNumAffected': 48, 'seriousNumAtRisk': 613, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 611, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 613, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 611, 'numEvents': 29, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 613, 'numEvents': 18, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 611, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 613, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 611, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Postpartum Hemorrhage (PPH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '520', 'groupId': 'OG000'}, {'value': '524', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'title': 'Did not have PPH (blood loss <1000 mL)', 'measurements': [{'value': '409', 'groupId': 'OG000'}, {'value': '399', 'groupId': 'OG001'}]}, {'title': 'Had PPH (blood loss >=1000 mL)', 'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.33', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.87', 'ciLowerLimit': '0.69', 'ciUpperLimit': '1.09', 'pValueComment': 'Threshold for statistical significance was 0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.1', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Postpartum hemorrhage defined as having a blood loss greater than or equal to 1000 mL using change in hemoglobin values. In the clinical trial, some participants in both arms had missing data because they did not have their laboratory measurements for hemoglobin done. In Group A (93 participants) and in Group B (87 participants) had missing assessments for PPH.'}, {'type': 'SECONDARY', 'title': 'Blood Loss Using Hemoglobin Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '513', 'groupId': 'OG000'}, {'value': '516', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '537.2', 'spread': '758.2', 'groupId': 'OG000'}, {'value': '528.6', 'spread': '1020.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Average blood loss in mL calculated using laboratory hemoglobin values collected from participants before and after procedure.'}, {'type': 'SECONDARY', 'title': 'Mean Blood Loss as Estimated by Obstetrician', 'denoms': [{'units': 'Participants', 'counts': [{'value': '590', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '501.2', 'spread': '209.8', 'groupId': 'OG000'}, {'value': '495.0', 'spread': '188.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours', 'description': 'Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data for some participants due to estimates not being done at the time of delivery.'}, {'type': 'SECONDARY', 'title': 'Occurrence of Postpartum Shock', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'title': 'No postpartum shock', 'categories': [{'measurements': [{'value': '603', 'groupId': 'OG000'}, {'value': '611', 'groupId': 'OG001'}]}]}, {'title': 'Postpartum shock', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Use of Supplementary Uterotonic(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '345', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'title': 'No supplementary uterotonic', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Supplementary uterotonic given', 'categories': [{'measurements': [{'value': '252', 'groupId': 'OG000'}, {'value': '232', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of women requiring supplementary uterotonics', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing information about additional uterotonics for some participants due to data entry issues after delivery.'}, {'type': 'SECONDARY', 'title': 'Postpartum Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'title': 'transfusion given', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'no transfusion given', 'measurements': [{'value': '603', 'groupId': 'OG000'}, {'value': '604', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of women given postpartum transfusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Emergency Surgery for PPH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '605', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'title': 'No emergency surgery', 'categories': [{'measurements': [{'value': '603', 'groupId': 'OG000'}, {'value': '601', 'groupId': 'OG001'}]}]}, {'title': 'Emergency Surgery done', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants who had emergency surgery for PPH including caesarean hysterectomies', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing information from some participants due to data entry issues.'}, {'type': 'SECONDARY', 'title': 'Change in Peripartum Haemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '1.1', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing values due to missing information if blood draws were not done within the required time frame.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Decrease in Peripartum Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '555', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'title': 'drop less than 2g/dl', 'categories': [{'measurements': [{'value': '438', 'groupId': 'OG000'}, {'value': '442', 'groupId': 'OG001'}]}]}, {'title': 'drop greater than or equal to 2g/dl', 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data a result of laboratory specimens not being collected at the expected time from participants'}, {'type': 'SECONDARY', 'title': 'Change in Peripartum Haematocrit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '556', 'groupId': 'OG000'}, {'value': '567', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum', 'unitOfMeasure': 'percent of hematocrit change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data due laboratory measurements not being done for some participants as samples were not taken within required time frame.'}, {'type': 'SECONDARY', 'title': 'Admission Into Intensive Care Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}, {'value': '606', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'title': 'Admitted into intensive care unit', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}, {'title': 'Not admitted to intensive care', 'measurements': [{'value': '525', 'groupId': 'OG000'}, {'value': '531', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants transferred to intensive care unit', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'data entry error for missing participant data'}, {'type': 'SECONDARY', 'title': 'Death From Any Cause', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'title': 'Number of Participants who lived', 'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}, {'title': 'Number of Participants who died', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to date of death or day 4 from admission', 'description': 'Number of participants who died from any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'title': 'systolic blood pressure 15 minutes after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '610', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '132.2', 'spread': '17.6', 'groupId': 'OG000'}, {'value': '131.2', 'spread': '18.0', 'groupId': 'OG001'}]}]}, {'title': 'diastolic blood pressure 15 minutes after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '607', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.9', 'spread': '33.8', 'groupId': 'OG000'}, {'value': '69.1', 'spread': '62.3', 'groupId': 'OG001'}]}]}, {'title': 'systolic blood pressure 30 minutes after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118.3', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '119.0', 'spread': '16.5', 'groupId': 'OG001'}]}]}, {'title': 'diastolic blood pressure 30 minutes after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '591', 'groupId': 'OG000'}, {'value': '586', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.8', 'spread': '14.5', 'groupId': 'OG000'}, {'value': '65.5', 'spread': '40.3', 'groupId': 'OG001'}]}]}, {'title': 'systolic blood pressure 45 minutes after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '592', 'groupId': 'OG000'}, {'value': '588', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '117.8', 'spread': '18.9', 'groupId': 'OG000'}, {'value': '118.7', 'spread': '18.3', 'groupId': 'OG001'}]}]}, {'title': 'diastolic blood pressure 45 minutes after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '602', 'groupId': 'OG000'}, {'value': '608', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '69.2', 'spread': '11.7', 'groupId': 'OG000'}, {'value': '68.2', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'systolic blood pressure 60 minutes after delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '609', 'groupId': 'OG000'}, {'value': '609', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123.6', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '124.2', 'spread': '16.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours after the caesarean section', 'description': 'Blood pressure at 15, 30, 45, 60, and 120 min after delivery', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some participants did not have their systolic and diastolic blood pressure measurements done (missing data)'}, {'type': 'SECONDARY', 'title': 'Number of Mild Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'title': 'Nausea', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}, {'title': 'No Nausea', 'categories': [{'measurements': [{'value': '602', 'groupId': 'OG000'}, {'value': '597', 'groupId': 'OG001'}]}]}, {'title': 'Vomiting', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'No Vomiting', 'categories': [{'measurements': [{'value': '582', 'groupId': 'OG000'}, {'value': '595', 'groupId': 'OG001'}]}]}, {'title': 'Dizziness', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'No Dizziness', 'categories': [{'measurements': [{'value': '599', 'groupId': 'OG000'}, {'value': '599', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 hours after administration', 'description': 'Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Severe Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'title': 'Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Deep Vein Thrombosis', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}]}, {'title': 'Pulmonary Embolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Pulmonary Embolism', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}]}, {'title': 'Myocardial Infarction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No Myocardial Infarction', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '612', 'groupId': 'OG001'}]}]}, {'title': 'Seizures', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Seizures', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}]}, {'title': 'Renal failure requiring dialysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'No Renal failure requiring dialysis', 'categories': [{'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 3 postpartum', 'description': '* Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound)\n* Pulmonary embolism (if the diagnosis is confirmed by radiological examination)\n* Myocardial infarction\n* Seizure\n* Renal failure requiring dialysis', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Any Other Unexpected Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'title': 'Unexpected events', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'No unexpected events', 'measurements': [{'value': '611', 'groupId': 'OG000'}, {'value': '613', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to day 3 postpartum', 'description': 'Number of unexpected events during and after the adminstration of study drug and duration of observation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '603', 'groupId': 'OG000'}, {'value': '605', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'OG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '1.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to day 3 postpartum', 'description': 'Duration of hospital admission in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing data due to data entry errors'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'FG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '613'}, {'groupId': 'FG001', 'numSubjects': '613'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '611'}, {'groupId': 'FG001', 'numSubjects': '613'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Study Group/Group A_(Tranexamic Acid)', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.\n\nTranexamic acid injection: Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section'}, {'id': 'BG001', 'title': 'Control Group/Group B_(Placebo)', 'description': 'There is an equivalent volume of normal saline for the control group.\n\nNormal saline placebo: 10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.1', 'spread': '6.2', 'groupId': 'BG000'}, {'value': '28.3', 'spread': '6.3', 'groupId': 'BG001'}, {'value': '28.7', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'less than 18 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'between 18-25 years', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}]}, {'title': 'between 26-35 years', 'measurements': [{'value': '322', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '643', 'groupId': 'BG002'}]}, {'title': 'greater than 35 years', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Females', 'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '74.6', 'spread': '16.2', 'groupId': 'BG000'}, {'value': '73.5', 'spread': '15.3', 'groupId': 'BG001'}, {'value': '74.0', 'spread': '15.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.5', 'spread': '11.4', 'groupId': 'BG000'}, {'value': '30.1', 'spread': '19.6', 'groupId': 'BG001'}, {'value': '29.8', 'spread': '15.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Abnormal Placentation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'No abnormal placentation', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Abnormal placentation present', 'measurements': [{'value': '610', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1223', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anemia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Anemia', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Not anemic', 'measurements': [{'value': '582', 'groupId': 'BG000'}, {'value': '593', 'groupId': 'BG001'}, {'value': '1175', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Comorbidities', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Comorbidities present', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'No comorbidities', 'measurements': [{'value': '563', 'groupId': 'BG000'}, {'value': '583', 'groupId': 'BG001'}, {'value': '1146', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fetal Macrosomia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Birth Weight <=4000g', 'measurements': [{'value': '578', 'groupId': 'BG000'}, {'value': '582', 'groupId': 'BG001'}, {'value': '1160', 'groupId': 'BG002'}]}, {'title': 'Birth Weight >4000g', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gestational Age (Weeks)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': '37 Weeks', 'measurements': [{'value': '93', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': '38 Weeks', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '318', 'groupId': 'BG002'}]}, {'title': '39 Weeks', 'measurements': [{'value': '147', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}, {'title': '40 Weeks', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '133', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}, {'title': '41 Weeks', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': '42+ Weeks', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of PPH', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'has had PPH', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'No history of PPH', 'measurements': [{'value': '603', 'groupId': 'BG000'}, {'value': '608', 'groupId': 'BG001'}, {'value': '1211', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HIV status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'HIV Positive', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}]}, {'title': 'HIV Negative', 'measurements': [{'value': '524', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '1043', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Multiple Pregnancy', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Had Multiple Pregnancy', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': 'No Multiple Pregnancy', 'measurements': [{'value': '570', 'groupId': 'BG000'}, {'value': '593', 'groupId': 'BG001'}, {'value': '1163', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of Previous Cesarean Sections', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '290', 'groupId': 'BG001'}, {'value': '554', 'groupId': 'BG002'}]}, {'title': 'One', 'measurements': [{'value': '192', 'groupId': 'BG000'}, {'value': '199', 'groupId': 'BG001'}, {'value': '391', 'groupId': 'BG002'}]}, {'title': 'Two', 'measurements': [{'value': '127', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '231', 'groupId': 'BG002'}]}, {'title': 'Three', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Four', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Polyhydramnios', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Polyhydramnios present', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'No polyhydramnios', 'measurements': [{'value': '609', 'groupId': 'BG000'}, {'value': '612', 'groupId': 'BG001'}, {'value': '1221', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous Surgery', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'had a previous surgery', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'No previous surgery', 'measurements': [{'value': '604', 'groupId': 'BG000'}, {'value': '599', 'groupId': 'BG001'}, {'value': '1203', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Uterine Fibroids', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '611', 'groupId': 'BG000'}, {'value': '613', 'groupId': 'BG001'}, {'value': '1224', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Uterine fibroids present', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'No uterine fibroids', 'measurements': [{'value': '604', 'groupId': 'BG000'}, {'value': '608', 'groupId': 'BG001'}, {'value': '1212', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-16', 'size': 369454, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-19T14:14', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This trial will be an open-label, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive TXA 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1226}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2021-01-16', 'resultsFirstSubmitDate': '2022-12-21', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-21', 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Postpartum Hemorrhage (PPH)', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.'}], 'secondaryOutcomes': [{'measure': 'Blood Loss Using Hemoglobin Values', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Calculated blood loss using hemoglobin values. A mean value of blood loss calculated using hemoglobin values'}, {'measure': 'Mean Blood Loss as Estimated by Obstetrician', 'timeFrame': '2 hours', 'description': 'Visually estimated blood loss at time of caesarean section. Attending obstetrician gave an estimated value of blood loss after delivery.'}, {'measure': 'Occurrence of Postpartum Shock', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants who had hypovolemic shock related to PPH as determined by assessing BP and pulse.'}, {'measure': 'Use of Supplementary Uterotonic(s)', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of women requiring supplementary uterotonics'}, {'measure': 'Postpartum Transfusion', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of women given postpartum transfusion'}, {'measure': 'Emergency Surgery for PPH', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants who had emergency surgery for PPH including caesarean hysterectomies'}, {'measure': 'Change in Peripartum Haemoglobin', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Mean change in haemoglobin concentration between the study group, calculated hemoglobin values at day 2 postpartum minus baseline hemoglobin values.'}, {'measure': 'Number of Participants With a Decrease in Peripartum Hemoglobin', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants with a drop in hemoglobin more than 2g/dL or less than 2g/dL'}, {'measure': 'Change in Peripartum Haematocrit', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Mean change in haematocrit percentage between the study groups from baseline to day 2 postpartum'}, {'measure': 'Admission Into Intensive Care Unit', 'timeFrame': 'Up to day 2 postpartum', 'description': 'Number of participants transferred to intensive care unit'}, {'measure': 'Death From Any Cause', 'timeFrame': 'Up to date of death or day 4 from admission', 'description': 'Number of participants who died from any cause'}, {'measure': 'Blood Pressure Measurements', 'timeFrame': 'Up to 2 hours after the caesarean section', 'description': 'Blood pressure at 15, 30, 45, 60, and 120 min after delivery'}, {'measure': 'Number of Mild Adverse Events', 'timeFrame': 'Up to 24 hours after administration', 'description': 'Number of mild events of nausea, vomiting, sensation of rings or spots of light in the visual field, dizziness'}, {'measure': 'Number of Severe Adverse Events', 'timeFrame': 'Up to day 3 postpartum', 'description': '* Deep vein thrombosis (if the diagnosis is confirmed by Doppler ultrasound)\n* Pulmonary embolism (if the diagnosis is confirmed by radiological examination)\n* Myocardial infarction\n* Seizure\n* Renal failure requiring dialysis'}, {'measure': 'Any Other Unexpected Adverse Event', 'timeFrame': 'Up to day 3 postpartum', 'description': 'Number of unexpected events during and after the adminstration of study drug and duration of observation'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Up to day 3 postpartum', 'description': 'Duration of hospital admission in days'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum hemorrhage', 'Tranexamic acid', 'Caesarean section', 'Prevent'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '37106343', 'type': 'DERIVED', 'citation': 'Gwanzura C, Gavi S, Mangiza M, Moyo FV, Lohman MC, Nhemachena T, Chipato T. Effect of anesthesia administration method on apgar scores of infants born to women undergoing elective cesarean section. BMC Anesthesiol. 2023 Apr 27;23(1):142. doi: 10.1186/s12871-023-02098-w.'}]}, 'descriptionModule': {'briefSummary': 'This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.', 'detailedDescription': 'This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Women undergoing elective or emergency caesarean section with:\n\n* Estimated gestational age of 37 weeks or more\n* Live intrauterine foetus\n* Elective or emergency caesarean delivery\n* Signed informed consent\n\nExclusion Criteria:\n\n* History of coagulopathies or conditions predisposing them to thromboembolic phenomena,\n* seizure history,\n* autoimmune disease,\n* placental abruption,\n* placenta praevia,\n* abnormally adherent placentae if identified on prenatal ultrasound,\n* eclampsia or HELLP syndrome,\n* known hypersensitivity to TXA,\n* planned general anaesthesia,\n* caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin,\n* poor understanding of English/Shona languages,\n* those who have received anticoagulants in the week before delivery\n* persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women'}, 'identificationModule': {'nctId': 'NCT04733157', 'acronym': 'ETAPPH', 'briefTitle': 'The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University of Zimbabwe'}, 'officialTitle': 'The Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Caesarean Section', 'orgStudyIdInfo': {'id': 'ETAPPH'}, 'secondaryIdInfos': [{'id': 'D43TW009343', 'link': 'https://reporter.nih.gov/quickSearch/D43TW009343', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group/Group A', 'description': 'The study group will receive TXA 1g intravenously at the onset of skin incision.', 'interventionNames': ['Drug: Tranexamic acid injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group/Group B', 'description': 'There is an equivalent volume of normal saline for the control group.', 'interventionNames': ['Other: Normal saline placebo']}], 'interventions': [{'name': 'Tranexamic acid injection', 'type': 'DRUG', 'otherNames': ['TXA'], 'description': 'Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section', 'armGroupLabels': ['Study group/Group A']}, {'name': 'Normal saline placebo', 'type': 'OTHER', 'description': '10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group', 'armGroupLabels': ['Control group/Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Sally Mugabe Central Hospital Maternity Unit', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Chipo Gwanzura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zimbabwe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not yet known if there will be a plan to make individual patient data (IPD) available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zimbabwe', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fogarty International Center of the National Institute of Health', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Registrar', 'investigatorFullName': 'Chipo Gwanzura, MD', 'investigatorAffiliation': 'University of Zimbabwe'}}}}