Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic
Primary Purpose
Post-Partum Hemorrhage
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Intervention group:
Sponsored by
About this trial
This is an interventional treatment trial for Post-Partum Hemorrhage
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group:
Control:
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Decrease PPH.
rates of Post-partum hemorrhage will be assessed by The difference between the groups
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.
Full Information
NCT ID
NCT02362945
First Posted
January 15, 2015
Last Updated
September 7, 2015
Sponsor
Yariv yogev
Collaborators
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02362945
Brief Title
Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic
Official Title
Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yariv yogev
Collaborators
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Partum Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group:
Arm Type
Experimental
Arm Description
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).
Arm Title
Control:
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Intervention group:
Other Intervention Name(s)
Hexakaprone-Transexamic acid and oxytocin
Intervention Description
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).
Primary Outcome Measure Information:
Title
Decrease post-partum hemoglobin decline.
Description
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.
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Decrease PPH.
Description
rates of Post-partum hemorrhage will be assessed by The difference between the groups
Time Frame
24 month
Title
Decrease the need for post-partum uterine manual revision.
Description
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.
Time Frame
24 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yariv Yogev, professor
Phone
9723-9377490
Email
yarivy@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yariv Yogev, professor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yariv Yogev, professor
Organizational Affiliation
Director, Division of obstetrics and delivery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic
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