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NCT02775773: TRANOXY2016

Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH

Completed Phase 3 Last updated 8 February 2024
What this trial tests

Phase 3 trial testing Tranexamic Acid in Post Partum Haemorrhage in 256 participants. Completed in 31 December 2018.

Timeline
30 January 2018
Primary endpoint
31 December 2018
31 December 2018

Quick facts

Lead sponsorAzienda U.S.L. 1 di Massa e Carrara
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment256
Start date30 January 2018
Primary completion31 December 2018
Estimated completion31 December 2018
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Azienda U.S.L. 1 di Massa e Carrara

Who can join

Adults 18 to 50, female only, with Post Partum Haemorrhage. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study was to evaluate that the tranexamic acid (TXA)Intravenous and oral, is equivalent oxytocin (OXY),intramuscularly, in reducing the blood loss in post partum period (mL) in patients at the end of pregnancy ( 37-42 w ) at low risk of post partum hemorrhage (PPH). The PPH means a blood loss equal to or greater than 500 ml after a vaginal delivery (the bleeding is defined severe if it exceeds 1000 mL). PPH is called "primary" when blood loss arose within 24 hours after birth.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial.
    Ragusa A, Ficarola F, Ferrari A, Spirito N, et al · · 2024 · cited 3× · PMID 38873634 · DOI 10.1016/j.eclinm.2024.102665

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Other trials of Tranexamic Acid

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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02775773.

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