Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04427618
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2020-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-06', 'studyFirstSubmitDate': '2020-06-07', 'studyFirstSubmitQcDate': '2020-06-09', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated blood loss', 'timeFrame': 'Intraoperative', 'description': 'This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) รท preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.'}], 'secondaryOutcomes': [{'measure': 'Change in hemoglobin and hematocrit level', 'timeFrame': 'Preoperative to 48 hours postoperative', 'description': 'Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery'}, {'measure': 'Need for additional medical intervention including blood transfusion, additional uterotonics', 'timeFrame': 'During surgery and up to 3 days after surgery'}, {'measure': 'Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery', 'timeFrame': 'During surgery and up to 24 hours from surgery'}, {'measure': 'Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism', 'timeFrame': 'Intraoperative to 4 weeks post surgery', 'description': 'Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery.'}, {'measure': 'Neonatal APGAR score', 'timeFrame': 'At delivery', 'description': 'Neonatal APGAR score at 1 and 5 minutes of life'}, {'measure': 'Neonatal birth weight', 'timeFrame': 'At delivery'}, {'measure': 'Neonatal admission to special care nursery or intensive care unit', 'timeFrame': 'At delivery'}, {'measure': 'Diagnosis of thromboembolic events in the neonate', 'timeFrame': 'Up to 4 weeks post delivery'}, {'measure': 'Gravimetric estimation of blood loss during the surgery', 'timeFrame': 'Intraoperative', 'description': 'This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted'}, {'measure': 'Provider estimated blood loss', 'timeFrame': 'Intraoperative', 'description': 'Estimated by the surgical team'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Hemorrhage', 'Tranexamic Acid']}, 'descriptionModule': {'briefSummary': 'In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process further by inhibiting the fibrinolytic system.\n\nTXA is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and recent evidence have found promising results in its use for prophylaxis of PPH.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All English speaking patients\n* Above 21 year old\n* Undergoing elective caesarean section.\n\nExclusion Criteria:\n\n* Known/suspected placenta accreta antenatally\n* Contraindications to syntocinon and tranexamic acid such as hypersensitivity to these medications\n* Known thrombophilia or coagulopathy\n* History of thromboembolic events\n* Severe cardiac/renal/liver disease\n* Poorly controlled hypertension /severe preeclampsia (BP \\> 160/100)/eclampsia'}, 'identificationModule': {'nctId': 'NCT04427618', 'briefTitle': 'Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '2019/2425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision, and Intravenous oxytocin 5 units post delivery of the baby.', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Tranexamic acid', 'type': 'DRUG', 'description': 'Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision', 'armGroupLabels': ['Intervention group']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Manisha Mathur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}