Pregnancy, High Risk
Conditions
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.
Interventions
1 gram of tranexamic acid to be administered intravenously
DRUGTranexamic Acid Oral Solution
4 grams of tranexamic acid given as an oral solution
1 gram of tranexamic acid given as 2 separate intramuscular injection
Sponsors
Rawalpindi Medical College
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic | 24 hours after randomisation | Concentration of TXA in Maternal blood over time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of D-dimer | up to 24 hours after randomisation | Maternal blood concentration over time |
| Maternal blood volume lost | from incision to 2 hours from CS | total blood loss |
| Placenta transfer of TXA | at birth of baby | Concentrations of TXA in placenta cord blood |
| Number of Adverse events (maternal and neonate) | from randomisation up to 7 days after | any untoward medical events |
| Number of women with a clinical diagnosis of PPH | 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 |
| frequency of Injection site reaction from IM administration | from randomisation up to 7 days after | Local reactions at injection site |
Countries
Pakistan, Zambia
Outcome results
None listed