NCT02775773

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

Longitudinal Clinical, Controlled, Randomized, Open-label, Phase III Study to Assess the Equivalence of Tranexamic Acid (TXA) vs Oxytocin (OXY) in Reducing Post Partum Haemorrhage (PPH) in Patients at the End of Pregnancy (37-42 w), at Low Risk of PPH

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: Azienda U.S.L. 1 di Massa e Carrara · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This trial includes three arms of treatment : * arm A (IMP1Test): TXA 500 mg/ 2 vials (1 gr) slow intravenous infusion 1ml/min within 5 minutes from the delivery(third stage af labor) * arm B (IMP2Control): OXY 5 IU/ml/ 2 vials (10 International Unit) intramuscularly within 5 minutes from the delivery (third stage af labor) The clamping of the umbilical cord will be executed immediately after birth. The randomization 1:1 (block design), generated by the computer. Primary outcomes: assessment of total blood loss expressed in mL: * immediately after delivery * two hours after delivery The measurement of the overall blood loss at delivery (ml) will be performed by the graduated bag, immediately after birth. The measurement two hours after delivery will be performed by weighing of the adsorbent material \[ N.ml = N. gr indicated by the balance - dry weight of the sanitary napkin\]. The overall loss in blood measured (ml) two hours of delivery will then be performed by adding the two collections.

Conditions

• Post Partum Haemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic Acid	2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor)
DRUG	Oxytocin	2 vials (=10 IU/International Unit) of Oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)

Timeline

• Start date: 2018-01-30
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2016-05-18
• Last updated: 2024-02-08

Locations

1 site across 1 country: Italy