WOMAN-Pharmaco TXA

Pharmacokinetics and pharmacodynamics of tranexamic acid in women having caesarean section birth

Trial Status: Recruiting

Start Date: 18 December 2020

Participants recruited to date: 54

Trial protocol: Generic, Zambia 

ClinicalTrials.gov

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: