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

Pregnancy, High Risk Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04274335
• Other study ID #: 2020-KEP-401
• Status: Completed
• Phase: Phase 2
• Start date: December 18, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: August 2022
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy, High Risk

Intervention

Drug:
• Tranexamic Acid 100Mg/Ml Inj Vil 10Ml
1 gram of tranexamic acid to be administered intravenously
• Tranexamic Acid Oral Solution
4 grams of tranexamic acid given as an oral solution
• Tranexamic Acid Injectable Product
1 gram of tranexamic acid given as 2 separate intramuscular injection

Locations

Country	Name	City	State
Pakistan	MCH PIMS	Islamabad
Zambia	Women and Newborn Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Rawalpindi Medical College

Countries where clinical trial is conducted

Pakistan,  Zambia, 

Outcome

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