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

Summary

Background Postpartum haemorrhage (PPH) is a major cause of maternal mortality worldwide accounting for 25% of maternal deaths. In Zimbabwe PPH is the second most common cause of death. Tranexamic acid (TXA) is widely used to reduce blood loss in elective surgery, bleeding trauma patients, and menorrhagia.

The investigators seek to determine the efficacy of TXA in reducing PPH during and after elective caesarean section.

Methods and Design The investigators intend to perform an open label randomized control study of 1,162 women who are undergoing elective caesarean section. The participants will be randomly selected to receive an intravenous infusion of TXA 10 minutes prior to skin incision or not to receive the intervention. Prophylactic oxytocin will be administered to all the women.

The primary outcome will be incidence of PPH defined by blood loss equal to or more than 1,000ml calculated by determining the difference in haematocrit values taken prior to and 48 hours after caesarean section.

Discussion In addition to prophylactic uterotonic administration, TXA is a complementary component acting on the haemostatic process that can be used in the third stage of labour to prevent PPH. It is a promising intervention that is cheap, easy to administer and would be easy to add to routine delivery protocols in hospitals. It would also help to conserve precious resources by reducing the need for blood products, and expensive surgical interventions to manage PPH.

This large adequately powered randomized study seeks to determine the efficacy of TXA to validate its routine use at caesarean section to prevent PPH.

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.

Sponsors & Collaborators

• University of Zimbabwe

  lead OTHER

Principal Investigators

• Tsungai Chipato, MBChB FRCOG · Professor of Obstetrics and Gynaecology

• Taazadza Nhemachena, MBChB MMED · Lecturer and Consultant

• Chipo Gwanzura, MBChB · Registrar

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-04-08

Primary Completion

2018-12-31

Completion

2019-06-30

FDA Drug

Yes

Countries

• Zimbabwe

Study Locations