NCT04733157

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,226 (actual)
• Sponsor: University of Zimbabwe · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. .

Conditions

• Postpartum Hemorrhage

Interventions

Type	Name	Description
DRUG	Tranexamic acid injection	Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section
OTHER	Normal saline placebo	10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group

Timeline

• Start date: 2021-03-23
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2021-02-01
• Last updated: 2023-03-20
• Results posted: 2023-03-20

Locations

2 sites across 1 country: Zimbabwe

Regulatory

• FDA-regulated drug study