Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 18 of 618 for:    Hemorrhage AND postpartum

Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Collaborator:
Rabin Medical Center
Information provided by (Responsible Party):
Yariv yogev, Rabin Medical Center

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].

Condition or disease Intervention/treatment Phase
Post-Partum Hemorrhage Drug: Intervention group: Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Decrease PPH. [ Time Frame: 24 month ]
    rates of Post-partum hemorrhage will be assessed by The difference between the groups

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Yariv Yogev, professor 9723-9377490 yarivy@clalit.org.il
Contact: Yariv Yogev, professor

Sponsors and Collaborators
Yariv yogev
Rabin Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Yariv Yogev, professor Director, Division of obstetrics and delivery

Layout table for additonal information
Responsible Party: Yariv yogev, Prof. Yariv Yogev Director, Division of obstetrics and delivery, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02362945     History of Changes
Other Study ID Numbers: 0656-14
First Posted: February 13, 2015    Key Record Dates
Last Update Posted: September 9, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Postpartum Hemorrhage
Puerperal Disorders
Uterine Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs