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

London School of Hygiene and Tropical Medicine120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

120

Conditions

Pregnancy, High Risk

Interventions

Tranexamic Acid 100Mg/Ml Inj Vil 10MlDRUG

1 gram of tranexamic acid to be administered intravenously

Tranexamic Acid Oral SolutionDRUG

4 grams of tranexamic acid given as an oral solution

Tranexamic Acid Injectable ProductDRUG

1 gram of tranexamic acid given as 2 separate intramuscular injection

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

MCH PIMS

Islamabad, Pakistan

Women and Newborn Hospital

Lusaka, Zambia

Outcomes

Primary Outcomes

Pharmacokinetic

Concentration of TXA in Maternal blood over time

Time frame: 24 hours after randomisation

Secondary Outcomes

Placenta transfer of TXA

Concentrations of TXA in placenta cord blood

Time frame: at birth of baby

Placenta transfer of TXA

Concentration of neonate TXA

Time frame: within 24 hours of birth

Concentration of D-dimer

Maternal blood concentration over time

Time frame: up to 24 hours after randomisation

Maternal blood volume lost

total blood loss

Time frame: from incision to 2 hours from CS

frequency of Injection site reaction from IM administration

Local reactions at injection site

Time frame: from randomisation up to 7 days after

Number of Adverse events (maternal and neonate)

any untoward medical events

Time frame: 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

Time frame: up to 24 hours after giving birth

Data from ClinicalTrials.gov

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