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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2021-09-30

Brief Summary

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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)

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Detailed Description

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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

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Pregnancy, High Risk

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intravenous tranexamic acid

Group Type EXPERIMENTAL

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

Intervention Type DRUG

1 gram of tranexamic acid to be administered intravenously

Intramuscular tranexamic acid

Group Type EXPERIMENTAL

Tranexamic Acid Injectable Product

Intervention Type DRUG

1 gram of tranexamic acid given as 2 separate intramuscular injection

Oral liquid tranexamic acid

Group Type EXPERIMENTAL

Tranexamic Acid Oral Solution

Intervention Type DRUG

4 grams of tranexamic acid given as an oral solution

No tranexamic acid

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

1 gram of tranexamic acid to be administered intravenously

Intervention Type DRUG

Tranexamic Acid Oral Solution

4 grams of tranexamic acid given as an oral solution

Intervention Type DRUG

Tranexamic Acid Injectable Product

1 gram of tranexamic acid given as 2 separate intramuscular injection

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No