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| Name | Class |
|---|---|
| Rawalpindi Medical College | OTHER |
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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous tranexamic acid | Experimental |
| |
| Intramuscular tranexamic acid | Experimental |
| |
| Oral liquid tranexamic acid | Experimental |
| |
| No tranexamic acid | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid 100Mg/Ml Inj Vil 10Ml | Drug | 1 gram of tranexamic acid to be administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic | Concentration of TXA in Maternal blood over time | 24 hours after randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Placenta transfer of TXA | Concentrations of TXA in placenta cord blood | at birth of baby |
| Placenta transfer of TXA | Concentration of neonate TXA |
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Inclusion Criteria:
Exclusion Criteria:
Women giving birth by caesarean section
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| Name | Affiliation | Role |
|---|---|---|
| Haleema Shakur-Still | London School of Hygiene and Tropical Medicine | Study Chair |
| Ian Roberts | London School of Hygiene and Tropical Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MCH PIMS | Islamabad | Pakistan | ||||
| Women and Newborn Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37019443 | Derived | 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. | |
| 34250266 |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Clinical Study Report | View IPD |
Totally anonymised dataset used for main analysis will be made freely available
freely available 1 year after main publication
Free login to website required for monitoring usage of data
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| Tranexamic Acid Oral Solution | Drug | 4 grams of tranexamic acid given as an oral solution |
|
| Tranexamic Acid Injectable Product | Drug | 1 gram of tranexamic acid given as 2 separate intramuscular injection |
|
| within 24 hours of birth |
| Concentration of D-dimer | Maternal blood concentration over time | up to 24 hours after randomisation |
| Maternal blood volume lost | total blood loss | from incision to 2 hours from CS |
| frequency of Injection site reaction from IM administration | Local reactions at injection site | from randomisation up to 7 days after |
| Number of Adverse events (maternal and neonate) | any untoward medical events | from randomisation up to 7 days after |
| Number of women with a clinical diagnosis of PPH | total blood loss of >1000 mL or any blood loss sufficient to cause haemodynamic instability or requires treatment | up to 24 hours after giving birth |
| Lusaka |
| Zambia |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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