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

2020-02-20 18:46:26 | BioPortfolio

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.

Study Design

Conditions

Pregnancy, High Risk

Intervention

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml, Tranexamic Acid Oral Solution, Tranexamic Acid Injectable Product

Location

Rawalpindi Medical University
Rawalpindi
Pakistan

Status

Not yet recruiting

Source

London School of Hygiene and Tropical Medicine

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-02-20T18:46:26-0500

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Medical and Biotech [MESH] Definitions

Antifibrinolytic hemostatic used in severe hemorrhage.

An acid-base indicator which is colorless in acid solution, but turns pink to red as the solution becomes alkaline. It is used medicinally as a cathartic.

The reversibly oxidized form of ascorbic acid. It is the lactone of 2,3-DIKETOGULONIC ACID and has antiscorbutic activity in man on oral ingestion.

Nitrous acid (HNO2). A weak acid that exists only in solution. It can form water-soluble nitrites and stable esters. (From Merck Index, 11th ed)

Measurement of this acid in the urine after oral administration of histidine provides the basis for the diagnostic test of folic acid deficiency and of megaloblastic anemia of pregnancy.

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