Clinical trial NCT02362945: Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic
Official title: Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post-Partum Hemorrhage
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: Rabin Medical Center
First posted: 2015-02-13
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 \[16\].

Detailed 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.

Eligibility 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).

Primary outcomes:
measure: Decrease post-partum hemoglobin decline.
timeFrame: 24 month
Secondary outcomes:
measure: Decrease PPH.
timeFrame: 24 month
measure: Decrease the need for post-partum uterine manual revision.
timeFrame: 24 month
Other outcomes:
Locations:
Study officials:
affiliation: Director, Division of obstetrics and delivery
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References: