Postpartum Hemorrhage

8 blood samples will be drawn: 1 at time of admission, then 15 min, 30min, 1h, 1.5h, 2h, 2.5h, and 3h post-treatment with TXA. Blood samples will be processed for ROTEM® analysis and for plasma concentration of TXA. TXA plasma concentrations will be modeled with a non-linear mixed-effects strategy using Monolix 4.1 and NONMEM(®) 7.2.

blood test

Brigham and Women's Hospital

Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage

Tranexamic Acid Administered After Delivery: Maternal Pharmacokinetics, Pharmacodynamics, and Coagulation Status

measured by ultra-performance liquid chromatography and mass spectometry

maternal blood will be evaluated with ROTEM EXTEM and FIBTEM assays

Michaela Kristina Farber, MD

Principal Investigator

This is a pilot study to determine the pharmacokinetics/pharmacodynamics of tranexamic acid administered after delivery to patients at high risk for postpartum hemorrhage, and coinciding coagulation testing using ROTEM®.

Participants receive a low dose of Tranexamic acid (10mg/kg) administered slowly over 5 minutes intravenously (iv) 10 minutes prior to skin incision in elective caesarean section with prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby.

Participants receive prophylactic oxytocin (5 IU iv) slow administration on delivery of the baby

Post Partum Hemorrhage

TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.

Tranexamic Acid

5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.

Oxytocin

Harare Central Hospital

Parirenyatwa Group of Hospitals

Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

Blood loss equal to or exceeding 1000ml following elective caesarean section

Blood loss during caesarean section based on visual estimation and calculation.

Requirement by participant of blood transfusion

Use of additional uterotonics such as an oxytocin infusion or prostaglandin use

Any adverse effects related to tranexamic acid use

Incidence of emergency surgical procedures to manage any postpartum haemorrhage that occurs

Duration of participants' stay in hospital

Apgar scores out of 10 at 1 minute and 5 minute

Reason for and number of days from admission to and duration of stay in neonatal unit

It is undecided whether the IPD will be made available to other researchers. Clearance is required first from ethical bodies and supervisors

Chipo Gwanzura, MD

Junior Registrar

University of Zimbabwe

Randomized control trial with two arms. Participants receive either 10mg/kg of TXA 10 minutes prior to elective caesarean section with prophylactic oxytocin administration after delivery of the baby, versus prophylactic oxytocin alone after delivery of the baby.

uterine inertia/diarreya

Tranexamic Acid Pharmacokinetics During Postpartum Hemorrhage

Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section

Effect of Adjunctive Misoprostol Treatment on Blood Loss at Vaginal Delivery

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