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

Summary

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.

Timeline

Start

2018-01-30

Primary completion

2018-12-31

Completion

2018-12-31

Publications

• Ragusa A, Ficarola F, Ferrari A, Spirito N, Ardovino M, Giraldi D, Stuzziero E, Rinaldo D, Procaccianti R, Larciprete G, De Luca C, D'Avino S, Principi G, Angioli R, Svelato A. Tranexamic acid versus oxytocin prophylaxis in reducing post-partum blood loss, in low-risk pregnant women: TRANOXY STUDY, a phase III randomized clinical trial. EClinicalMedicine. 2024 May 31;73:102665. doi: 10.1016/j.eclinm.2024.102665. eCollection 2024 Jul.

Drugs

Indications

No indication recorded.