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

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ClinicalTrials.gov Identifier: NCT04274335
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 5, 2021
Sponsor:
Collaborator:
Rawalpindi Medical College
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Study Description
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Brief 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)

Condition or disease Intervention/treatment Phase
Pregnancy, High Risk Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml Drug: Tranexamic Acid Oral Solution Drug: Tranexamic Acid Injectable Product Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intravenous tranexamic acid Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
1 gram of tranexamic acid to be administered intravenously
Experimental: Intramuscular tranexamic acid Drug: Tranexamic Acid Injectable Product
1 gram of tranexamic acid given as 2 separate intramuscular injection
Experimental: Oral liquid tranexamic acid Drug: Tranexamic Acid Oral Solution
4 grams of tranexamic acid given as an oral solution
No Intervention: No tranexamic acid


Outcome Measures
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Primary Outcome Measures :
  1. Pharmacokinetic [ Time Frame: 24 hours after randomisation ]
    Concentration of TXA in Maternal blood over time


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women giving birth by caesarean section
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04274335


Contacts
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Contact: Haleema Shakur-Still +44 207 958 8113 Haleema.Shakur@lshtm.ac.uk

Locations
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Pakistan
MCH PIMS Recruiting
Islamabad, Pakistan
Contact: S Batool         
Zambia
Women and Newborn Hospital Recruiting
Lusaka, Zambia
Contact: K Lubeya         
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Rawalpindi Medical College
Investigators
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Study Chair: Haleema Shakur-Still London School of Hygiene and Tropical Medicine
Study Chair: Ian Roberts London School of Hygiene and Tropical Medicine
More Information
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT04274335    
Other Study ID Numbers: 2020-KEP-401
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Totally anonymised dataset used for main analysis will be made freely available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: freely available 1 year after main publication
Access Criteria: Free login to website required for monitoring usage of data
URL: https://freebird.lshtm.ac.uk

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants