Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic
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|ClinicalTrials.gov Identifier: NCT02362945|
Recruitment Status : Unknown
Verified September 2015 by Yariv yogev, Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : February 13, 2015
Last Update Posted : September 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Post-Partum Hemorrhage||Drug: Intervention group:||Phase 3|
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 . 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  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 . Tissue injury during cesarean section may convert the hemostatic equilibrium towards fibrinolysis that results in excessive bleeding / 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 . 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 , 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 .
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 . PPH is the major maternal cause of death, with 100000 cases per year .
Thus the investigators sought to investigate the efficacy of Hexakapron, as a prophylactic treatment after vaginal delivery and cesarean section, in reducing PPH.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||January 2017|
|Estimated Study Completion Date :||January 2017|
Experimental: 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 (sodium chloride)0.9% solution IV). ( the oxytocin is the routine practice in our department).
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).
Other Name: Hexakaprone-Transexamic acid and oxytocin
No Intervention: Control:
Treatment with oxytocin after fetal extraction (10 units in 100ml NaCl 0.9% solution IV). as commonly given for Post-Partum Hemorrhage (PPH) at our obstetrical ward.Active Comparator: (this is the routine practice in our department).
- Decrease post-partum hemoglobin decline. [ Time Frame: 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.
- Decrease PPH. [ Time Frame: 24 month ]rates of Post-partum hemorrhage will be assessed by The difference between the groups
- Decrease the need for post-partum uterine manual revision. [ Time Frame: 24 month ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02362945
|Contact: Yariv Yogev, firstname.lastname@example.org|
|Contact: Yariv Yogev, professor|
|Principal Investigator:||Yariv Yogev, professor||Director, Division of obstetrics and delivery|