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

University of Zimbabwe1,226 enrolled

Overview

This study seeks to determine if the using tranexamic acid prophylactically at caesarean section will prevent postpartum haemorrhage which is a major cause of maternal mortality in Zimbabwe and globally.

This trial will be an placebo-controlled, two-centre, randomized control trial with two parallel groups including 1,162 women who undergo elective or emergency caesarean deliveries at term. The study group will receive tranexamic acid (TXA) 1g intravenously at the onset of skin incision. There is normal saline placebo for the control group. The study and control groups will both receive the standard care offered at caesarean section including 5 IU of oxytocin intravenously on delivery of the baby. .

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

1,226

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic acid injectionDRUG

Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section

Normal saline placeboOTHER

10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group

Eligibility

Sex: FEMALE

Medical Language ↔ Plain English

Inclusion Criteria: Women undergoing elective or emergency caesarean section with: * Estimated gestational age of 37 weeks or more * Live intrauterine foetus * Elective or emergency caesarean delivery * Signed informed consent Exclusion Criteria: * History of coagulopathies or conditions predisposing them to thromboembolic phenomena, * seizure history, * autoimmune disease, * placental abruption, * placenta praevia, * abnormally adherent placentae if identified on prenatal ultrasound, * eclampsia or HELLP syndrome, * known hypersensitivity to TXA, * planned general anaesthesia, * caesarean delivery for the second twin or second/third triplet(s) after vaginal birth of the first twin, * poor understanding of English/Shona languages, * those who have received anticoagulants in the week before delivery * persons-under-investigation for Coronavirus disease (COVID-19) and confirmed COVID-19 positive women

Locations (2)

Parirenyatwa Group of Hospitals (Mbuya Nehanda Maternity Hospital)

Harare, Zimbabwe

Sally Mugabe Central Hospital Maternity Unit

Harare, Zimbabwe

Outcomes

Primary Outcomes

Number of Participants With Postpartum Hemorrhage (PPH)

Calculated estimated blood loss exceeding 1000ml. Estimated Blood Loss (EBL) was calculated using laboratory values of hemoglobin levels before and after procedure. Postpartum hemorrhage is defined as blood loss exceeding 1000mL after cesarean section.