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Hexakaprone Treatment for Post-Partum Hemorrhage Prophylactic

NCT02362945 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2015-09-09

No results posted yet for this study

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 \[16\].

Conditions

  • Post-Partum Hemorrhage

Interventions

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).

Sponsors & Collaborators

  • Rabin Medical Center

    collaborator OTHER

  • Yariv yogev

    lead OTHER

Principal Investigators

  • Yariv Yogev, professor · Director, Division of obstetrics and delivery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2017-01-31
Completion
2017-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02362945 on ClinicalTrials.gov