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

PHASE3CompletedINTERVENTIONAL
Enrollment

506

Participants

Timeline

Start Date

April 8, 2018

Primary Completion Date

December 31, 2018

Study Completion Date

June 30, 2019

Conditions
Post Partum Hemorrhage
Interventions
DRUG

Tranexamic Acid

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.

DRUG

Oxytocin

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

Trial Locations (2)

Unknown

Harare Central Hospital, Harare

Parirenyatwa Group of Hospitals, Harare

All Listed Sponsors
lead

University of Zimbabwe

OTHER

NCT03463993 - Efficacy of Tranexamic Acid in Preventing Postpartum Haemorrhage After Elective Caesarean Section | Biotech Hunter | Biotech Hunter