Status:
COMPLETED
Pharmacokinetics and Pharmacodynamics of Tranexamic Acid in Women Having Caesarean Section Birth [WOMAN-PharmacoTXA]
Lead Sponsor:
London School of Hygiene and Tropical Medicine
Collaborating Sponsors:
Rawalpindi Medical College
Conditions:
Pregnancy, High Risk
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 popu...
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 b...
Eligibility Criteria
Inclusion
- Women admitted to hospital giving birth by CS
- History of at least one risk factor for PPH
- Adult (≥18 years old)
Exclusion
- 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
Key Trial Info
Start Date :
December 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04274335
Start Date
December 18 2020
End Date
September 30 2021
Last Update
May 23 2023
Active Locations (2)
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1
MCH PIMS
Islamabad, Pakistan
2
Women and Newborn Hospital
Lusaka, Zambia