Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-25 @ 8:09 PM
Study NCT ID:
NCT04274335
Status:
COMPLETED
Last Update Posted:
2023-05-23
First Post:
2020-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2020-02-14', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2023-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic', 'timeFrame': '24 hours after randomisation', 'description': 'Concentration of TXA in Maternal blood over time'}], 'secondaryOutcomes': [{'measure': 'Placenta transfer of TXA', 'timeFrame': 'at birth of baby', 'description': 'Concentrations of TXA in placenta cord blood'}, {'measure': 'Placenta transfer of TXA', 'timeFrame': 'within 24 hours of birth', 'description': 'Concentration of neonate TXA'}, {'measure': 'Concentration of D-dimer', 'timeFrame': 'up to 24 hours after randomisation', 'description': 'Maternal blood concentration over time'}, {'measure': 'Maternal blood volume lost', 'timeFrame': 'from incision to 2 hours from CS', 'description': 'total blood loss'}, {'measure': 'frequency of Injection site reaction from IM administration', 'timeFrame': 'from randomisation up to 7 days after', 'description': 'Local reactions at injection site'}, {'measure': 'Number of Adverse events (maternal and neonate)', 'timeFrame': 'from randomisation up to 7 days after', 'description': 'any untoward medical events'}, {'measure': 'Number of women with a clinical diagnosis of PPH', 'timeFrame': 'up to 24 hours after giving birth', 'description': 'total blood loss of \\>1000 mL or any blood loss sufficient to cause haemodynamic instability or requires treatment'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pregnancy, High Risk']}, 'referencesModule': {'references': [{'pmid': '37019443', 'type': 'DERIVED', 'citation': 'Shakur-Still H, Roberts I, Grassin-Delyle S, Chaudhri R, Geer A, Arribas M, Lamy E, Mansukhani R, Lubeya MK, Javaid K, Kayani A, Israr N, Mazhar SB, Urien S, Bouazza N, Foissac F, Prowse D, Carrington L, Barrow C, Onandia JG, Balogun E. Alternative routes for tranexamic acid treatment in obstetric bleeding (WOMAN-PharmacoTXA trial): a randomised trial and pharmacological study in caesarean section births. BJOG. 2023 Sep;130(10):1177-1186. doi: 10.1111/1471-0528.17455. Epub 2023 Apr 5.'}, {'pmid': '34250266', 'type': 'DERIVED', 'citation': 'Arribas M, Roberts I, Chaudhri R, Geer A, Prowse D, Lubeya MK, Kayani A, Javaid K, Grassin-Delyle S, Shakur-Still H. WOMAN-PharmacoTXA trial: Study protocol for a randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral administration of tranexamic acid in women giving birth by caesarean section. Wellcome Open Res. 2021 Jun 16;6:157. doi: 10.12688/wellcomeopenres.16884.1. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Intramuscular injection and oral solution of tranexamic acid (TXA) would increase its use in situations where administration of intravenous drugs is difficult. The investigators aim to assess the population pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous, intramuscular and oral TXA in women undergoing undergoing caesarean section (CS) with at least one known risk factor for postpartum haemorrhage (PPH)', 'detailedDescription': 'An open label, randomised controlled trial to assess the pharmacokinetics and pharmacodynamics of intramuscular, intravenous and oral solution administration of tranexamic acid in women giving birth by caesarean section. 120 women (30 receiving oral liquid, 30 receiving intramuscular, 30 receiving intravenous and 30 receiving no TXA who have at least 6 evaluable PK samples will be randomised.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Women giving birth by caesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women admitted to hospital giving birth by CS\n* History of at least one risk factor for PPH\n* Adult (≥18 years old)\n\nExclusion Criteria:\n\n* Women giving birth vaginally\n* Women with a known allergy to TXA or its excipients\n* Women with current antepartum haemorrhage\n* Women known to have received TXA within 48 hours prior to randomisation\n* Women with known renal impairment\n* Women with any known blood clotting disorder'}, 'identificationModule': {'nctId': 'NCT04274335', 'briefTitle': 'Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'A Randomised Controlled Trial to Assess the Pharmacokinetics and Pharmacodynamics of Intramuscular, Intravenous and Oral Administration of Tranexamic Acid in Women Giving Birth by Caesarean Section', 'orgStudyIdInfo': {'id': '2020-KEP-401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml']}, {'type': 'EXPERIMENTAL', 'label': 'Intramuscular tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid Injectable Product']}, {'type': 'EXPERIMENTAL', 'label': 'Oral liquid tranexamic acid', 'interventionNames': ['Drug: Tranexamic Acid Oral Solution']}, {'type': 'NO_INTERVENTION', 'label': 'No tranexamic acid'}], 'interventions': [{'name': 'Tranexamic Acid 100Mg/Ml Inj Vil 10Ml', 'type': 'DRUG', 'description': '1 gram of tranexamic acid to be administered intravenously', 'armGroupLabels': ['Intravenous tranexamic acid']}, {'name': 'Tranexamic Acid Oral Solution', 'type': 'DRUG', 'description': '4 grams of tranexamic acid given as an oral solution', 'armGroupLabels': ['Oral liquid tranexamic acid']}, {'name': 'Tranexamic Acid Injectable Product', 'type': 'DRUG', 'description': '1 gram of tranexamic acid given as 2 separate intramuscular injection', 'armGroupLabels': ['Intramuscular tranexamic acid']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Islamabad', 'country': 'Pakistan', 'facility': 'MCH PIMS', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}, {'city': 'Lusaka', 'country': 'Zambia', 'facility': 'Women and Newborn Hospital', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Haleema Shakur-Still', 'role': 'STUDY_CHAIR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}, {'name': 'Ian Roberts', 'role': 'STUDY_CHAIR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'ipdSharingStatementModule': {'url': 'https://freebird.lshtm.ac.uk', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'freely available 1 year after main publication', 'ipdSharing': 'YES', 'description': 'Totally anonymised dataset used for main analysis will be made freely available', 'accessCriteria': 'Free login to website required for monitoring usage of data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rawalpindi Medical College', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}