Clinical trial NCT04274335: Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pregnancy, High Risk
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Rawalpindi Medical College
First posted: 2020-02-18
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Pharmacokinetic
timeFrame: 24 hours after randomisation
Secondary outcomes:
measure: Placenta transfer of TXA
timeFrame: at birth of baby
measure: Placenta transfer of TXA
timeFrame: within 24 hours of birth
measure: Concentration of D-dimer
timeFrame: up to 24 hours after randomisation
measure: Maternal blood volume lost
timeFrame: from incision to 2 hours from CS
measure: frequency of Injection site reaction from IM administration
timeFrame: from randomisation up to 7 days after
measure: Number of Adverse events (maternal and neonate)
timeFrame: from randomisation up to 7 days after
measure: Number of women with a clinical diagnosis of PPH
timeFrame: up to 24 hours after giving birth
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: MCH PIMS
city: Lusaka
country: Zambia
facility: Women and Newborn Hospital
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Haleema Shakur-Still
role: STUDY_CHAIR
affiliation: London School of Hygiene and Tropical Medicine
name: Ian Roberts
role: STUDY_CHAIR
References:
citation: 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.