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NCT Number: NCT04274335

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

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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Key information

Conditions

Pregnancy, High Risk

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

MCH PIMS, Islamabad, Pakistan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

Drug

1 gram of tranexamic acid to be administered intravenously

Tranexamic Acid Oral Solution

Drug

4 grams of tranexamic acid given as an oral solution

Tranexamic Acid Injectable Product

Drug

1 gram of tranexamic acid given as 2 separate intramuscular injection

Primary outcomes

  1. Pharmacokinetic

    Time frame: 24 hours after randomisation

    Concentration of TXA in Maternal blood over time

Secondary outcomes

  1. Placenta transfer of TXA

    Time frame: at birth of baby

    Concentrations of TXA in placenta cord blood

  2. Placenta transfer of TXA

    Time frame: within 24 hours of birth

    Concentration of neonate TXA

  3. Concentration of D-dimer

    Time frame: up to 24 hours after randomisation

    Maternal blood concentration over time

  4. Maternal blood volume lost

    Time frame: from incision to 2 hours from CS

    total blood loss

  5. frequency of Injection site reaction from IM administration

    Time frame: from randomisation up to 7 days after

    Local reactions at injection site

  6. Number of Adverse events (maternal and neonate)

    Time frame: from randomisation up to 7 days after

    any untoward medical events

  7. Number of women with a clinical diagnosis of PPH

    Time frame: up to 24 hours after giving birth

    total blood loss of >1000 mL or any blood loss sufficient to cause haemodynamic instability or requires treatment

Sponsors and collaborators

Lead sponsor

London School of Hygiene and Tropical Medicine

Other

Collaborators

  • Rawalpindi Medical College

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 18, 2020
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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