Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic

Post-Partum Hemorrhage Clinical Trial

Official title:

Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02362945
• Other study ID #: 0656-14
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 15, 2015
• Last updated: September 7, 2015
• Start date: October 2015
• Est. completion date: January 2017

Study information

• Verified date: September 2015
• Source: Rabin Medical Center
• Contact: Yariv Yogev, professor
• Phone: 9723-9377490
• Email: yarivy[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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].

Description:

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] The increase in plasma volume during pregnancy, and uterine perfusion that reaches 750ml/min near term [3] are causes for excessive blood loss during vaginal or cesarean delivery. Blood loss is approximately 500ml and 1000ml during vaginal and cesarean delivery respectively. Studies have shown that blood transfusion treatment reaches to up to 6 % after cesarean section [5-6].

During placental delivery fibrinogen and fibrin degradation and plasminogen activation occurs. This causes fibrinolytic cascade that continues 6-10 hours post-partum [7]. Tissue injury during cesarean section may convert the hemostatic equilibrium towards fibrinolysis that results in excessive bleeding [8]/ 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].

PPH jeopardize young reproductive women's health, it is specifically related to major morbidity in the context of prior anemia which features this population in high rates [17]. PPH is the major maternal cause of death, with 100000 cases per year [6].

Thus the investigators sought to investigate the efficacy of Hexakapron, as a prophylactic treatment after vaginal delivery and cesarean section, in reducing PPH.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Post-Partum Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Intervention group:
Treatment with 1 gr hexakapron Intra-Venous (IV) after delivery of the fetus in addition to accepted treatment with oxytocin (10 units in 100ml NaCl 0.9% solution IV).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Yariv yogev	Rabin Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease post-partum hemoglobin decline.	Assessment of the hemoglobin decline - the decline will be calculated as the gap between the hemoglobin level prior delivery and the the hemoglobin measured 48-72 hours post delivery.	24 month	No
Secondary	Decrease PPH.	rates of Post-partum hemorrhage will be assessed by The difference between the groups	24 month	No
Secondary	Decrease the need for post-partum uterine manual revision.	rates of Post-partum uterine manual revision will be assessed by The difference between the groups the difference will be assessed by a chi-square test.	24 month	No