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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2024
• Main ID: NCT02503319
• Date of registration: 26/06/2015
• Prospective Registration: Yes
• Primary sponsor: Azienda U.S.L. 1 di Massa e Carrara
• Public title: Clinical Study to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the PPH (TRANOXY2015) TRANOXY2015
• Scientific title: Clinical Study,Longitudinal,Controlled, Randomized, Open-label, Phase III,to Assess the Equivalence of Tranexamic Acid vs Oxytocin in Reducing the Post Partum Hemorrhage (PHH) in Patients at the End of Pregnancy (37-42 w) at Low Risk of PPH
• Date of first enrolment: January 2016
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/ct2/show/NCT02503319
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Contacts

• Name: Antonio Ragusa, Dr
• Affiliation: Azienda USL1 di Massa e Carrara

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Postpartum Hemorrhage

Intervention(s)

Drug: Oxytocin

Drug: Tranexamic Acid

Primary Outcome(s)

assessment of total blood loss expressed in mL [Time Frame: immediately after delivery]

assessment of total blood loss expressed in mL [Time Frame: two hours after delivery]

Secondary Outcome(s)

assessment of the need of using additional uterotonic [Time Frame: immediately after delivery]

assessment of the need of using additional uterotonic [Time Frame: two hours after delivery]

assessment of the number of hemodynamic changes [Time Frame: immediately after delivery]

assessment of the number of hemodynamic changes [Time Frame: two hours after delivery]

assessment the need for surgical manoeuvres for the bleeding control [Time Frame: immediately after delivery]

assessment the need for surgical manoeuvres for the bleeding control [Time Frame: two hours after delivery]

assessment the need for the blood transfusions [Time Frame: two days after delivery]

Secondary ID(s)

AzUSL1 di Massa e Carrara

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Dr.Antonio Franco Ragusa