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

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)

Timeline

Start

2020-12-18

Primary completion

2021-06-30

Completion

2021-09-30

Publications

• Shakur-Still H, Roberts I, Grassin-Delyle S, Chaudhri R, Geer A, Arribas M, Lamy E, Mansukhani R, Lubeya MK, Javaid K, Kayani A, Israr N, Mazhar SB, Urien S, Bouazza N, Foissac F, Prowse D, Carrington L, Barrow C, Onandia JG, Balogun E. Alternative routes for tranexamic acid treatment in obstetric bleeding (WOMAN-PharmacoTXA trial): a randomised trial and pharmacological study in caesarean section births. BJOG. 2023 Sep;130(10):1177-1186. doi: 10.1111/1471-0528.17455. Epub 2023 Apr 5.
• Arribas M, Roberts I, Chaudhri R, Geer A, Prowse D, Lubeya MK, Kayani A, Javaid K, Grassin-Delyle S, Shakur-Still H. WOMAN-PharmacoTXA trial: Study protocol for 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. Wellcome Open Res. 2021 Jun 16;6:157. doi: 10.12688/wellcomeopenres.16884.1. eCollection 2021.

Drugs

Indications

No indication recorded.