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Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]

Pregnancy, High Risk Clinical Trial

Official title:
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

Clinical Trial Summary

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)

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04274335
Study type Interventional
Source London School of Hygiene and Tropical Medicine
Contact
Status Completed
Phase Phase 2
Start date December 18, 2020
Completion date September 30, 2021
View Details
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