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

• Status: Suspended
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: Female

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 .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda U.S.L. 1 di Massa e Carrara
• Collaborator: Dr.Antonio Franco Ragusa
• Treatments: Oxytocin; Tranexamic Acid

Criteria

Inclusion Criteria:

• Subjects at the end of pregnancy ( 37-42 w ) at low risk of PPH Mean by low-risk of PPH subjects without any of the following risk factors : hypertension/preeclampsia, placental abruption during pregnancy , placenta previa , tocolysis two hours before delivery, multiple pregnancy , previous PPH, obesity ( BMI > 35 ), anemia (Hb < 7 g/dL), elective caesarean section , induction of labor, retention of placental material , polyhydramnios , fever during labor, use of high doses of heparin low molecular weight.

• Subjects full capacity and the willingness to give written informed consent .

Exclusion Criteria:

• Subjects with preterm pregnancy (<37 weeks ) or with prolonged pregnancy ( > 42 weeks )

• Subjects at the end of pregnancy ( 37 weeks - 42 weeks ) with the following risk factors for PPH (Tab1)

• multiple pregnancy

• history of thromboembolic disease or high incidence of thromboembolic events in family history ( patients at high risk of thrombophilia )

• Patients with Long - QT syndrome or who are taking drugs that cause QT prolongation

• Intrauterine fetal Death

• epilepsy

• autoimmune disease Tab1 medical history :

• Placental abruption during pregnancy

• placenta previa

• Hypertension / preeclampsia

• previous PPH

• polyhydramnios

• Obesity ( BMI > 35 )

• Anemia ( < 7 g / dL )

Detectable in labor:

• Elective caesarean section

• Tocolysis two hours before delivery

• Induction of labor

• Retention of placental material

• Fever during labor

• Use of low molecular weight heparin