NCT04274335

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: London School of Hygiene and Tropical Medicine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Detailed 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.

Conditions

• Pregnancy, High Risk

Interventions

Type	Name	Description
DRUG	Tranexamic Acid 100Mg/Ml Inj Vil 10Ml	1 gram of tranexamic acid to be administered intravenously
DRUG	Tranexamic Acid Oral Solution	4 grams of tranexamic acid given as an oral solution
DRUG	Tranexamic Acid Injectable Product	1 gram of tranexamic acid given as 2 separate intramuscular injection

Timeline

• Start date: 2020-12-18
• Primary completion: 2021-06-30
• Completion: 2021-09-30
• First posted: 2020-02-18
• Last updated: 2023-05-23

Locations

2 sites across 2 countries: Pakistan, Zambia