drugset / Trial / NCT02362945

Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic

NCT02362945

Phase 3 Unknown 1000 enrolled Yariv yogev Rabin Medical Center · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Post-Partum Hemorrhage (PPH) is a common obstetrical complication. It may occur after both vaginal and cesarean delivery with a reported prevalence of 4-6% of deliveries \[1\]. Prophylactic treatment with oxytocin after fetus extraction is a common practice. \[1,2\]Transexamic acid - Hexakapron is a potent antifibrinolytic, it prevents lysine adhesion to plasminogen molecules by blocking its binding site. It can lower fibrinolysis rate and by that reduce bleeding \[9\]. Systematic treatment of anti-fibrinolytic drugs is in surgical practice after procedures such as coronary artery bypass graft, orthopedic surgeries and liver transplantation \[10-13\]. Hexakapron is an FDA approved drug, it is defined as a class B drug for pregnancy and lactation \[12\], it is already being used in a non-routine fashion in the delivery room during PPH.In obstetrics Hexakapron given before vaginal or cesarean delivery has been presumed to decrease blood loss and PPH. 2 studies that included 453 woman reported decrease in PPH (RR 0.51, 95% CI 0.36 to 0.72) \[13-15\]. However specific protocols for prophylactic treatment with Hexakapron as available with oxytocin are lacking, and further research is necessary to determine such guidelines \[16\].

Timeline

Start
2015-10
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Hexakaprone Unknown 1 g Intravenous
Background Oxytocin Peptide 10 iu Intravenous

Indications

No indication recorded.