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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

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)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Collaborator: Rawalpindi Medical College
• Treatments: Tranexamic Acid

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