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

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 2

Conditions: Pregnancy, High Risk

Treatments: Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml; Drug: Tranexamic Acid Injectable Product; Drug: Tranexamic Acid Oral Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT04274335

2020-KEP-401

Details and patient eligibility

About

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)

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women admitted to hospital giving birth by CS
• History of at least one risk factor for PPH
• Adult (≥18 years old)

Exclusion criteria

• Women giving birth vaginally
• Women with a known allergy to TXA or its excipients
• Women with current antepartum haemorrhage
• Women known to have received TXA within 48 hours prior to randomisation
• Women with known renal impairment
• Women with any known blood clotting disorder

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 4 patient groups

Intravenous tranexamic acid

Experimental group

Treatment:

Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

Intramuscular tranexamic acid

Experimental group

Treatment:

Drug: Tranexamic Acid Injectable Product

Oral liquid tranexamic acid

Experimental group

Treatment:

Drug: Tranexamic Acid Oral Solution

No tranexamic acid

No Intervention group