Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.

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

Details

• Lead Sponsor: University Hospital, Angers
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Oxytocin; Tranexamic Acid

Criteria

Inclusion Criteria:

• Age≥ 18 years

• Planned vaginal delivery

• Term ≥ 35 weeks of gestation

• Singleton pregnancy

• Informed consent form signed

Exclusion Criteria:

• History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis.

• History of epilepsy or seizure

• Any known cardiovascular, renal, liver disorders

• Auto-immune disease

• Sickle cell disease

• Severe hemorrhagic disease

• Placenta previa

• Abnormally invasive placenta (placenta accreta/increta/percreta)

• Abruptio placentae

• Eclampsia; hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome

• Multiple pregnancy

• In utero foetal death

• Administration of Low-Molecular-Weight Heparin or antiplatelet agents seven days before delivery

• Poor understanding of the French language