Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 11:34 AM
Study NCT ID:
NCT03463993
Status:
COMPLETED
Last Update Posted:
2022-06-01
First Post:
2018-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-11-23', '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'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chipo.gwanzura@gmail.com', 'phone': '+263774718381', 'title': 'Dr Chipo Gwanzura', 'organization': 'University of Zimbabwe'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The a priori power was not been achieved as the target sample size had not yet been achieved due to reasons beyond the scope of the study. The study had no placebo and was not blinded.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected up to the time the patient and baby were discharged from hospital which on average is on the third day post-caesarean section.', 'description': 'The risk of serious adverse events is zero as these are rare events with tranexamic acid administration. The all-cause mortality is zero again as this is a rare event. The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus congestion (25.4%), abdominal pain (12 - 19.8%), diarrhoea (12.2%), fatigue (5.2%) and anaemia (5.6%). The WOMAN Trial collaborators found that TXA reduces mortality due to bleeding in women with PPH with no adverse effects.', 'eventGroups': [{'id': 'EG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.', 'otherNumAtRisk': 224, 'deathsNumAtRisk': 224, 'otherNumAffected': 7, 'seriousNumAtRisk': 224, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.', 'otherNumAtRisk': 227, 'deathsNumAtRisk': 227, 'otherNumAffected': 3, 'seriousNumAtRisk': 227, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 224, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 227, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Postpartum Haemorrhage (PPH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'title': 'PPH based on Haematocrit calculation', 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}, {'title': 'PPH based on Haemoglobin calculation', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.549', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The p-value above is the calculated P value based on hematocrit.', 'groupDescription': 'The null hypothesis was that intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.138', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'This is the calculated p-value based on hemoglobin .', 'groupDescription': 'The null hypothesis was that intravenous Tranexamic Acid (TXA)10mg/kg plus Oxytocin 5IU does not result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 48 hours post-caesarean section', 'description': 'PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Estimated Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'title': 'Visually estimated blood loss', 'categories': [{'measurements': [{'value': '483.73', 'spread': '182.56', 'groupId': 'OG000'}, {'value': '479.61', 'spread': '139.49', 'groupId': 'OG001'}]}]}, {'title': 'Haematocrit-based calculation of estimated blood loss', 'categories': [{'measurements': [{'value': '650.06', 'spread': '631.50', 'groupId': 'OG000'}, {'value': '653.05', 'spread': '796.03', 'groupId': 'OG001'}]}]}, {'title': 'Haemoglobin-based calculation of estimated blood loss', 'categories': [{'measurements': [{'value': '644.30', 'spread': '692.27', 'groupId': 'OG000'}, {'value': '707.68', 'spread': '948.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.789', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.789 is the calculated p-value for visually estimated blood loss: Visually estimated blood loss (ml): Group A mean 483.73 (standard deviation182.56); Group B 479.61 (139.49); p-value 0.789', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.968', 'groupIds': ['OG000', 'OG001'], 'pValueComment': '0.968 is the calculated p-value based on hematocrit. Hematocrit-based calculation of estimated blood loss(ml): Group A mean 650.06 (standard deviation 631.50); Group B 653.05 (796.03); p-value 0.968', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.447', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Hemoglobin-based calculation of estimated blood loss(ml) mean(standard deviation): Group A 644.30 (692.27); Group B 707.68 (948.01); p-value 0.447', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At caesarean section', 'description': 'Blood loss during caesarean section based on visual estimation and calculation.', 'unitOfMeasure': 'ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Amount of Blood Transfused', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '2'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '3'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEDIAN', 'timeFrame': 'At caesarean section up to 48 hours post-caesarean section', 'description': 'Requirement by participant of blood transfusion', 'unitOfMeasure': 'units of blood given', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Use of Additional Uterotonics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At caesarean section up to 48 hours post-caesarean section', 'description': 'Number of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Tranexamic Acid Side Effects', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From intravenous infusion of the drug up to 48 hours post-caesarean section', 'description': 'Number of participants with adverse effects related to tranexamic acid use', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Number of Participants Requiring Emergency Surgery for PPH', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At caesarean section up to 48 hours post-caesarean section', 'description': 'Number of participants requiring emergency surgical procedures to manage any PPH that occurs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': "Number of Days of Participants' Hospital Stay", 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000', 'lowerLimit': '4', 'upperLimit': '5'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier', 'description': 'The number of days the participant stayed in hospital from the date of admission to date of discharge from hospital.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome - Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '3087.85', 'spread': '523.98', 'groupId': 'OG000'}, {'value': '3109.98', 'spread': '513.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Neonatal birth weight in grams', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'title': 'Apgar score at 1 minute', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '8', 'upperLimit': '9'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '8', 'upperLimit': '9'}]}]}, {'title': 'Apgar score at 5 minutes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '10'}, {'value': '9', 'groupId': 'OG001', 'lowerLimit': '9', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Scores at 1 minute from time of delivery and at 5 minutes after delivery', 'description': 'APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scores out of 10 at 1 minute and 5 minutes. A measure of the physical condition of a newborn infant. It is obtained by adding points (maximum score of 2, 1, or 0 as minimum score) for Appearance (0 - blue/pale, 1 - pink body, blue extremities, 2 - pink); Pulse (0 - absent heart rate, 1 - below 100 beats per minute, 2 - over 100 beats per minute), Grimace (Reflex irritability - 0 - floppy, 1 - minimal response to stimulation, 2- prompt response to stimulation), Activity (muscle tone: 0 - absent, 1 - Flexed arms and legs, 2 - active), Respiration ( 0 - absent, 1 - slow or irregular, 2 - vigorous cry). APGAR score at 1minute or 5 minute can be a minimum of of 0 (0+0+0+0+0) or maximum of 10 (2 for each parameter above).', 'unitOfMeasure': 'units on a scale up to 10', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat analysis'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Number of neonates requiring admission to the neonatal unit from time of delivery at caesarean section', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome - Number of Neonates Diagnosed With Jaundice', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Number of neonates with clinical jaundice (yellowing of the skin or whites of the eyes)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome - Thromboembolic Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Number of neonatal thromboembolic events', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}, {'type': 'SECONDARY', 'title': 'Neonatal Outcome - Death', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'OG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Neonatal death that occurs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention-to-treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'FG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '253'}, {'groupId': 'FG001', 'numSubjects': '253'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '224'}, {'groupId': 'FG001', 'numSubjects': '227'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Had a vaginal delivery prior to caesarean delivery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Had emergency caesarean delivery prior to elective caesarean delivery', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'From 8 April 2018 to 31 December 2018, we recruited 506 eligible patients. The trial was conducted at two tertiary institutions that are affiliated to the University of Zimbabwe. These serve as referral centres for 12 local authority clinics located in Harare as well as district and provincial hospitals in the surrounding provinces: Harare Central Hospital i.e. Harare Maternity Hospital (HMH) and Parirenyatwa Group of Hospitals i.e. Mbuya Nehanda Maternity Hospital (MNMH).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.\n\nTranexamic Acid: TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'BG001', 'title': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby\n\nOxytocin: 5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.5', 'spread': '6.0', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '6.5', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '6.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black African', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Zimbabwe', 'categories': [{'measurements': [{'value': '224', 'groupId': 'BG000'}, {'value': '227', 'groupId': 'BG001'}, {'value': '451', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Gestational age', 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000', 'lowerLimit': '38', 'upperLimit': '40'}, {'value': '39', 'groupId': 'BG001', 'lowerLimit': '38', 'upperLimit': '40'}, {'value': '39', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '40'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'HIV status', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '186', 'groupId': 'BG000'}, {'value': '187', 'groupId': 'BG001'}, {'value': '373', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Multiple pregnancy', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Placenta praevia', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Uterine fibroids', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '78.3', 'spread': '14.9', 'groupId': 'BG000'}, {'value': '78.2', 'spread': '15.2', 'groupId': 'BG001'}, {'value': '78.3', 'spread': '15.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index', 'classes': [{'categories': [{'measurements': [{'value': '29.8', 'spread': '5.3', 'groupId': 'BG000'}, {'value': '30.5', 'spread': '5.5', 'groupId': 'BG001'}, {'value': '30.1', 'spread': '5.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Number of previous caesarean sections', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}, {'title': '2', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': '≥3', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': '0', 'measurements': [{'value': '99', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '182', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Previous surgery', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Anaemia (Hb < 11 g/dl)', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '51', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Foetal macrosomia (birth weight > 4000g)', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Breech presentation', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Risk assessment for PPH', 'classes': [{'categories': [{'title': 'Low', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '195', 'groupId': 'BG001'}, {'value': '389', 'groupId': 'BG002'}]}, {'title': 'Medium', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'High', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Type of anaesthesia', 'classes': [{'categories': [{'title': 'General', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}, {'title': 'Regional (spinal)', 'measurements': [{'value': '176', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '364', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-30', 'size': 1272236, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-10-23T04:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Trial is an open label randomized control trial'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized control trial with two arms. Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 506}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2018-02-17', 'resultsFirstSubmitDate': '2021-10-23', 'studyFirstSubmitQcDate': '2018-03-06', 'lastUpdatePostDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-03-23', 'studyFirstPostDateStruct': {'date': '2018-03-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Postpartum Haemorrhage (PPH)', 'timeFrame': 'Up to 48 hours post-caesarean section', 'description': 'PPH based on Haematocrit calculation and PPH based on Haemoglobin calculation'}], 'secondaryOutcomes': [{'measure': 'Estimated Blood Loss', 'timeFrame': 'At caesarean section', 'description': 'Blood loss during caesarean section based on visual estimation and calculation.'}, {'measure': 'Amount of Blood Transfused', 'timeFrame': 'At caesarean section up to 48 hours post-caesarean section', 'description': 'Requirement by participant of blood transfusion'}, {'measure': 'Number of Participants With Use of Additional Uterotonics', 'timeFrame': 'At caesarean section up to 48 hours post-caesarean section', 'description': 'Number of participants who received additional uterotonics such as an oxytocin infusion or prostaglandin (misoprostol).'}, {'measure': 'Number of Participants With Tranexamic Acid Side Effects', 'timeFrame': 'From intravenous infusion of the drug up to 48 hours post-caesarean section', 'description': 'Number of participants with adverse effects related to tranexamic acid use'}, {'measure': 'Number of Participants Requiring Emergency Surgery for PPH', 'timeFrame': 'At caesarean section up to 48 hours post-caesarean section', 'description': 'Number of participants requiring emergency surgical procedures to manage any PPH that occurs'}, {'measure': "Number of Days of Participants' Hospital Stay", 'timeFrame': 'From date of randomization until the day 2 post-caesarean section (date of discharge from hospital) or date of death whichever comes earlier', 'description': 'The number of days the participant stayed in hospital from the date of admission to date of discharge from hospital.'}, {'measure': 'Neonatal Outcome - Weight', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Neonatal birth weight in grams'}, {'measure': 'Neonatal Outcome - APGAR Score of the Neonates at 1 Minute and 5 Minutes After Delivery', 'timeFrame': 'Scores at 1 minute from time of delivery and at 5 minutes after delivery', 'description': 'APGAR (Appearance, Pulse, Grimace, Activity, Respiration) scores out of 10 at 1 minute and 5 minutes. A measure of the physical condition of a newborn infant. It is obtained by adding points (maximum score of 2, 1, or 0 as minimum score) for Appearance (0 - blue/pale, 1 - pink body, blue extremities, 2 - pink); Pulse (0 - absent heart rate, 1 - below 100 beats per minute, 2 - over 100 beats per minute), Grimace (Reflex irritability - 0 - floppy, 1 - minimal response to stimulation, 2- prompt response to stimulation), Activity (muscle tone: 0 - absent, 1 - Flexed arms and legs, 2 - active), Respiration ( 0 - absent, 1 - slow or irregular, 2 - vigorous cry). APGAR score at 1minute or 5 minute can be a minimum of of 0 (0+0+0+0+0) or maximum of 10 (2 for each parameter above).'}, {'measure': 'Neonatal Outcome - Number of Neonates Admitted to the Neonatal Unit', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Number of neonates requiring admission to the neonatal unit from time of delivery at caesarean section'}, {'measure': 'Neonatal Outcome - Number of Neonates Diagnosed With Jaundice', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Number of neonates with clinical jaundice (yellowing of the skin or whites of the eyes)'}, {'measure': 'Neonatal Outcome - Thromboembolic Event', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Number of neonatal thromboembolic events'}, {'measure': 'Neonatal Outcome - Death', 'timeFrame': 'From date of delivery of neonate by caesarean section until day 2 post-caesarean section (the date of discharge from hospital) or date of death whichever comes earlier', 'description': 'Neonatal death that occurs'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Post Partum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.\n\nThe investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.\n\nMethods and Design The investigators intend to perform an open label randomized control study of 1,162 women who are undergoing elective caesarean section. The participants will be randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision or not to receive the intervention. Prophylactic oxytocin will be administered to all the women.\n\nThe primary outcome will be incidence of PPH defined by blood loss equal to or more than 1,000ml calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section.\n\nDiscussion In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.\n\nThis large adequately powered randomized study seeks to determine the efficacy of TXA to validate its routine use at caesarean section to prevent PPH.', 'detailedDescription': "RESEARCH QUESTION Does intravenous Tranexamic Acid (TXA) 10mg/kg plus Oxytocin 5 International Units (IU) result in a lower incidence of primary postpartum haemorrhage compared to Oxytocin alone after elective caesarean section.\n\nRATIONALE FOR THE RESEARCH Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe, PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.\n\nIn addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.\n\nThe investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.\n\nRESEARCH OBJECTIVES\n\n1. To assess the impact of TXA (10mg/kg) given 10 minutes prior to elective caesarean section on postpartum blood loss\n2. To assess the potential adverse effects of TXA given 10 minutes prior to elective caesarean section Primary Outcome\n\n * Incidence of PPH defined by blood loss equal to or exceeding 1000ml following elective caesarean section Secondary Outcomes\n * Estimated blood loss during caesarean section\n * Need for blood transfusion\n * Use of additional uterotonics (such as oxytocin infusion or prostaglandins)\n * TXA side effects\n * Incidence of emergency surgery for PPH\n * Duration of mother's postnatal hospital stay\n * Neonatal outcome RESEARCH METHODOLOGY Research Design The aim of this study is to compare the effect of a low dose of TXA (10mg/kg) administered 10 minutes prior to elective caesarean section with prophylactic oxytocin administration, versus prophylactic oxytocin alone in an open label randomized clinical trial (RCT). An RCT is appropriate as it aims to reduce bias when testing this potentially new intervention.\n\nTarget Population Women undergoing elective caesarean sections at Harare and Parirenyatwa Hospitals based on set inclusion and exclusion criteria Inclusion criteria Pregnant woman with signed informed consent, who understand English and/or Shona, at estimated gestational age of 38 weeks or older, requiring Elective Caesarean Section, with a live intrauterine fetus.\n\nExclusion criteria Placental Abruption, emergency caesarean section, current or previous history of significant disease including heart disease, liver, renal disorders; known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke); history of epilepsy or seizures; autoimmune disease; sickle cell disease; severe haemorrhagic disease; intrauterine fetal demise; eclampsia/HELLP syndrome; administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery.\n\nSample Size A total sample size of 1,162 (581 per group) was calculated assuming a proportion of 2.1% PPH in the experimental group and 5.8% in the control group at 95% confidence interval and 90% power using Fleiss formula.\n\nSubjects' state of physical health Healthy Intervention Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.\n\nAssessment Questionnaire (attached). Vital signs (heart rate, blood pressure, respiratory rate) noted before surgery, immediately after placental delivery, and 1 to 2 hours after birth Full blood count (FBC), Urea \\& electrolytes (u\\&e) and liver function tests (LFTs) performed a day before delivery (routinely performed) U\\&e, LFTs and FBC assessed 48 hours after delivery. Estimated blood loss (EBL) using the difference in hematocrit values taken prior to and 48 hours after caesarean delivery.\n\nThe investigators will also note the standard EBL based on estimates made by the anaesthetist after assessment of patient's linen and abdominal swabs.\n\nRISKS AND BENEFITS The common adverse effects include headaches (50.4 - 60.4%), backaches (20.7 - 31.4%), nasal sinus problem (25.4%), abdominal pain (12 - 19.8%), diarrhea (12.2%), fatigue (5.2%) and anaemia (5.6%).\n\nThe WOMAN Trial collaborators found that TXA actually reduces mortality due to bleeding in women with PPH with no adverse effects.\n\nTranexamic acid potentiates the blood clotting system and is used to treat and prevent bleeding. Use of TXA could potentially prevent PPH due to factors other than uterine atony, where uterotonics will not be effective.\n\nCOSTS AND COMPENSATION Study participants will not receive any compensation. The cost of TXA shall not be incurred by the study participants. They will bear their usual admission and caesarean section costs that they would otherwise have borne had they not participated in the study.\n\nINFORMED CONSENT All subjects or legally authorized representatives for minors are expected to be give informed consent.\n\nCONFIDENTIALITY ASSURANCES Information collected from the participants shall be confidential, will be assigned a code and no personal identifiers will be used. Information collected will be stored in a secure place only accessible to the researcher and assistants, as well as on a password-protected laptop computer. Consent forms will be kept for three years after the completion of the investigation unless stipulated otherwise by the Medical Research Council of Zimbabwe.\n\nCONFLICTS OF INTERESTS The study is being carried out in partial fulfillment of the degree of Masters of Medicine in Obstetrics and Gynaecology. No other gains are to be obtained from carrying out the study.\n\nCOLLABORATIVE AGREEMENTS N/A INTENDED USE OF RESULTS The results of the study will be submitted to the College of Health Sciences as part of the requirements for completion of the degree of Masters of Medicine in Obstetrics and Gynaecology, and may be considered for publications to add to the current body of knowledge on the use of TXA."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant woman with signed informed consent\\*\\*\\*\n* Understand English and/or Shona\n* Estimated gestational age of 38 weeks or older\n* Requiring Elective Caesarean Section defined as caesarean section performed before onset of labour\n* Live intrauterine fetus\n\n * The study will enrol participants who are Pregnant and who have a signed informed Consent form. Some of the pregnant women may be minors as they are occasionally included in patients planned for elective caesarean section for varying indications. Their inclusion also will make the results of the trial generalizable to elective caesarean section patients attended to at the two study hospitals. Consent will be sought from a legally authorized representative such as the parent or guardian.\n\nExclusion Criteria:\n\n* Placental Abruption\n* Emergency caesarean section\n* Current or previous history of significant disease including heart disease, liver, renal disorders\n* Known coagulopathy or history of deep venous thrombosis and/or pulmonary embolism, or arterial thrombosis (angina pectoris, myocardial infarction, stroke)\n* History of epilepsy or seizures\n* Autoimmune disease\n* Sickle cell disease\n* Severe haemorrhagic disease\n* Intrauterine fetal demise\n* Eclampsia/HELLP syndrome\n* Administration of anticoagulants - clexane or antiplatelet agents in the week prior to delivery'}, 'identificationModule': {'nctId': 'NCT03463993', 'briefTitle': 'Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'University of Zimbabwe'}, 'officialTitle': 'Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section', 'orgStudyIdInfo': {'id': 'ETAPPPH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.', 'interventionNames': ['Drug: Tranexamic Acid', 'Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['TXA'], 'description': 'TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.', 'armGroupLabels': ['Group A']}, {'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['Prophylactic oxytocin'], 'description': '5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.', 'armGroupLabels': ['Group A', 'Group B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Harare Central Hospital', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}, {'city': 'Harare', 'country': 'Zimbabwe', 'facility': 'Parirenyatwa Group of Hospitals', 'geoPoint': {'lat': -17.82772, 'lon': 31.05337}}], 'overallOfficials': [{'name': 'Tsungai Chipato, MBChB FRCOG', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Obstetrics and Gynaecology'}, {'name': 'Taazadza Nhemachena, MBChB MMED', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer and Consultant'}, {'name': 'Chipo Gwanzura, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Registrar'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'TBA', 'ipdSharing': 'YES', 'description': 'It is undecided whether the IPD will be made available to other researchers. Clearance is required first from ethical bodies and supervisors', 'accessCriteria': 'Communicate with researcher on chipo.gwanzura@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zimbabwe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Junior Registrar', 'investigatorFullName': 'Chipo Gwanzura, MD', 'investigatorAffiliation': 'University of Zimbabwe'}}}}