TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery

• Status: Completed
• Trial end date: 2020-04-08
• Target enrollment: 0
• Participant gender: Female

Summary

The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).

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

Details

• Lead Sponsor: University Hospital, Bordeaux
• Collaborator: Ministry of Health, France
• Treatments: Pharmaceutical Solutions; Tranexamic Acid

Criteria

Inclusion Criteria:

• : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks,

• hemoglobin level at the last blood sample >9g/dl,

• available blood test for Hb and Ht within one week before caesarean delivery,

• informed signed consent

Exclusion Criteria:

• previous thrombotic event or preexisting pro-thrombotic disease,

• epileptic state or history of seizures,

• presence of any chronic or active cardiovascular disease outside hypertension,

• any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease,

• sickle cell disease,

• placenta praevia,

• placenta accreta/increta/percreta,

• abruption placentae,

• eclampsia,

• HELLP syndrome,

• significant hemorrhage before cesarean section

• in utero fetal death,

• administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,

• planned general anesthesia,

• hypersensitivity to tranexamic acid or concentrated hydrochloric acid,

• instrumental extraction failure,

• multiple pregnancy with vaginal delivery of the first child,

• poor understanding of the French language.