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
Overview
- Phase
- Phase 2
- Intervention
- Tranexamic Acid Injectable Product
- Conditions
- Pregnancy, High Risk
- Sponsor
- London School of Hygiene and Tropical Medicine
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Pharmacokinetic
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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)
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.
Investigators
Eligibility 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
Arms & Interventions
Intramuscular tranexamic acid
Intervention: Tranexamic Acid Injectable Product
Intravenous tranexamic acid
Intervention: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
Oral liquid tranexamic acid
Intervention: Tranexamic Acid Oral Solution
Outcomes
Primary Outcomes
Pharmacokinetic
Time Frame: 24 hours after randomisation
Concentration of TXA in Maternal blood over time
Secondary Outcomes
- Number of women with a clinical diagnosis of PPH(up to 24 hours after giving birth)
- Concentration of D-dimer(up to 24 hours after randomisation)
- Maternal blood volume lost(from incision to 2 hours from CS)
- frequency of Injection site reaction from IM administration(from randomisation up to 7 days after)
- Placenta transfer of TXA(within 24 hours of birth)
- Number of Adverse events (maternal and neonate)(from randomisation up to 7 days after)