NCT02362945

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 \[16\].

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 13, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

January 15, 2015

Last Update Submit

September 7, 2015

Conditions

Post-Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 month

Secondary Outcomes (2)

  • Decrease PPH.

    24 month

  • Decrease the need for post-partum uterine manual revision.

    24 month

Study Arms (2)

Intervention group:

EXPERIMENTAL

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:

Control:

NO INTERVENTION

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).

Interventions

Intervention group:DRUG

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).

Also known as: Hexakaprone-Transexamic acid and oxytocin
Intervention group:

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Normal vaginal delivery.
  • Operative vaginal delivery (Vaccum and Forceps).
  • Elective cesarean section.
  • Age 18-50.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Yariv Yogev, professor

    Director, Division of obstetrics and delivery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yariv Yogev, professor

CONTACT

9723-9377490yarivy@clalit.org.il

Yariv Yogev, professor

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Yariv Yogev Director, Division of obstetrics and delivery

Study Record Dates

First Submitted

January 15, 2015

First Posted

February 13, 2015

Study Start

October 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

September 9, 2015

Record last verified: 2015-09