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

Phase 2

Completed

• Conditions: Pregnancy, High Risk
• Interventions: Drug: Tranexamic Acid Injectable Product; Drug: Tranexamic Acid 100Mg/Ml Inj Vil 10Ml; Drug: Tranexamic Acid Oral Solution

• Registration Number: NCT04274335
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Study Start: 2020-12-18
• Primary Completion: 2021-06-30
• Study Completion: 2021-09-30
• Status Verified: 2022-08
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramuscular tranexamic acid	Tranexamic Acid Injectable Product	-
Intravenous tranexamic acid	Tranexamic Acid 100Mg/Ml Inj Vil 10Ml	-
Oral liquid tranexamic acid	Tranexamic Acid Oral Solution	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic	24 hours after randomisation	Concentration of TXA in Maternal blood over time

Secondary Outcome Measures

Name	Time	Method
Number of women with a clinical diagnosis of PPH	up to 24 hours after giving birth	total blood loss of \>1000 mL or any blood loss sufficient to cause haemodynamic instability or requires treatment
Concentration of D-dimer	up to 24 hours after randomisation	Maternal blood concentration over time
Maternal blood volume lost	from incision to 2 hours from CS	total blood loss
frequency of Injection site reaction from IM administration	from randomisation up to 7 days after	Local reactions at injection site
Placenta transfer of TXA	within 24 hours of birth	Concentration of neonate TXA
Number of Adverse events (maternal and neonate)	from randomisation up to 7 days after	any untoward medical events

Trial Locations

Locations (2)

MCH PIMS; 🇵🇰 Islamabad, Pakistan

Women and Newborn Hospital; 🇿🇲 Lusaka, Zambia