Overview

Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic

Status:
Unknown status
Trial end date:
2017-01-01
Target enrollment:
0
Participant gender:
Female
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].
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yariv yogev
Collaborator:
Rabin Medical Center
Treatments:
Oxytocin
Criteria
Inclusion Criteria:

- Normal vaginal delivery.

- Operative vaginal delivery (Vaccum and Forceps).

- Elective cesarean section.

- Age 18-50.

Exclusion Criteria:

- Excessive pain (VAS>4).

- Blood clotting disturbance or any major hematologic disease.

- Suspected Placenta-Previa.

- Multiple gestations.

- Contraindications for Hexakapron treatment:

- Atrial fibrillation.

- Coronary arteries stenting.

- CABG(coronary artery bypass graft) in past year.

- Hematuria (prior to pregnancy).