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

NCT04274335 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-05-23

No results posted yet for this study

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)

Conditions

  • Pregnancy, High Risk

Interventions

DRUG

Tranexamic Acid 100Mg/Ml Inj Vil 10Ml

1 gram of tranexamic acid to be administered intravenously

DRUG

Tranexamic Acid Oral Solution

4 grams of tranexamic acid given as an oral solution

DRUG

Tranexamic Acid Injectable Product

1 gram of tranexamic acid given as 2 separate intramuscular injection

Sponsors & Collaborators

  • Rawalpindi Medical College

    collaborator OTHER

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Principal Investigators

  • Haleema Shakur-Still · London School of Hygiene and Tropical Medicine

  • Ian Roberts · London School of Hygiene and Tropical Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2021-06-30
Completion
2021-09-30

Countries

  • Pakistan
  • Zambia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04274335 on ClinicalTrials.gov