drugset / Trial / NCT02503319

Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015)

NCT02503319

RandomizedParallel-groupOpen-labelTreatment

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. This is a open-trial randomized, longitudinal, controlled that including 486 subjects .

Timeline

Start
2016-01
Primary completion
2016-01
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Oxytocin Peptide 10 iu Intramuscular
Subject Tranexamic Acid Small molecule 1 g Oral

Indications

No indication recorded.