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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
Yariv yogev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Partum Hemorrhage

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    January 15, 2015
    Last Updated
    September 7, 2015
    Sponsor
    Yariv yogev
    Collaborators
    Rabin Medical Center
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    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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