跳至主要内容
临床试验/NCT02362945
NCT02362945Unknown3 期

Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic

Yariv yogev0 个研究点目标入组 1,000 人开始时间: 2015年10月最近更新:
适应症
相关药物

试验速览

阶段
3 期
发起方
Yariv yogev
入组人数
1,000
主要终点
Decrease post-partum hemoglobin decline.

研究概览

简要总结

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].

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Normal vaginal delivery.
  • Operative vaginal delivery (Vaccum and Forceps).
  • Elective cesarean section.
  • Age 18-50.

排除标准

  • 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).

结局指标

主要结局

Decrease post-partum hemoglobin decline.

时间窗: 24 month

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.

次要结局

  • Decrease PPH.(24 month)
  • Decrease the need for post-partum uterine manual revision.(24 month)

研究者

发起方
Yariv yogev
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yariv yogev

Prof. Yariv Yogev Director, Division of obstetrics and delivery

Rabin Medical Center

相似试验