NCT04427618

Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section

Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

In obstetrics, postpartum haemorrhage (PPH) continues to be a major contributor to maternal morbidity and mortality worldwide. Uterine atony is the most common cause of PPH, and the prophylactic use of uterotonics, specifically oxytocin, is the standard of care for PPH prophylaxis. It is believed that tranexamic acid (TXA) can enhance the hemostatic process further by inhibiting the fibrinolytic system. TXA is an antifibrinolytic that has been studied in many different patient population for its use in reducing blood loss ranging from gynaecological and non gynaecological surgeries, to trauma patients. It has been found to reduce mortality in treatment of patients with PPH, and recent evidence have found promising results in its use for prophylaxis of PPH.

Conditions

• Postpartum Hemorrhage
• Tranexamic Acid

Interventions

Type	Name	Description
DRUG	Tranexamic acid	Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
DRUG	Normal saline	Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-10-03
• Completion: 2022-02-01
• First posted: 2020-06-11
• Last updated: 2022-11-09

Locations

1 site across 1 country: Singapore