Pharmacokinetics and pharmacodynamics of tranexamic acid in women having caesarean section birth
Trial Status: Completed Recruitement. Results published
Start Date: 18 December 2020
Participants recruited to date: 120
Trial Summary:
Intravenous administration of tranexamic acid (TXA) within 3 hours of birth significantly reduces death due to bleeding in women with postpartum haemorrhage (PPH). Most PPH deaths occur in the first hours after giving birth and treatment delay decreases survival. One barrier to rapid TXA treatment is the need for intravenous (IV) injection, as trained medical personnel are not always available when the emergency occurs. Intramuscular (IM) injection and oral solution of TXA would be easier and faster to administer and would require less training than IV use. However, the pharmacokinetics (PK), pharmacodynamics and safety of TXA administered by different routes in pregnant women have not yet been established.
The main aim of this study is to ascertain whether IM and oral solution of TXA will be well absorbed at levels sufficient to inhibit fibrinolysis in pregnant women.
Our Collaborators:
Zambia National Principal Investigator:
- Dr Mwansa Ketty Lubeya
Zambia WOMAN-PharmacacoTXA Trial Site:
- Women and Newborn Hospital, Lusaka
Pakistan WOMAN-PharmacacoTXA Trial Sites:
- Pakistan Institute of Medical Sciences, Mother and Child Health Centre Unit I, Islamabad
- Federal Government Polyclinic HospitalDepartment of Obstetrics and Gynaecology, Islamabad
PK Laboratory/Analysis:
Prof Stanislas Grassin-Delyle
Laboratory at UFR Simone Veil – Santé
University Versailles Saint Quentin
Montigny le Bretonneux
Participant Documents:
- Participant information sheet and consent form v1.1 Pakistan English
- Participant information sheet and consent form v1.1 Pakistan Urdu
- Participant information sheet and consent form v1.2 Zambia_English
- Participant information sheet and consent form v1.2 Zambia_Bemba
- Participant information sheet and consent form v1.2 Zambia_Nyanja
Results:
WOMAN-PharmacoTXA Trial found that injecting TXA into the muscle, was safe and quickly reached high enough concentrations in pregnant women. Oral treatment was also safe but it took an hour to reach high enough concentrations in the blood, so it would not be suitable as an emergency treatment.
These results are very important because they show that TXA injected into the muscle may be an alternative to the current administration into the vein, which is not always possible when the birth takes place at home, away from a hospital or in very busy hospitals
These results provide the basis for a Phase 3 trial to test whether the injection into the muscle works as well as the injection into the vein for reducing postpartum bleeding. The I’M WOMAN trial, starting later this year, will be addressing this question.
Link to publication:
Please find the link to the paper published online on the 5th of April 2023 in the BJOG: An International Journal of Obstetrics and Gynaecology
http://doi.org/10.1111/1471-0528.17455