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

KK Women's and Children's Hospital

Status and phase: Completed; Phase 3

Conditions: Tranexamic Acid; Postpartum Hemorrhage

Treatments: Drug: Tranexamic acid; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT04427618

2019/2425

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: Female

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• All English speaking patients
• Above 21 year old
• Undergoing elective caesarean section.

Exclusion criteria

• Known/suspected placenta accreta antenatally
• Contraindications to syntocinon and tranexamic acid such as hypersensitivity to these medications
• Known thrombophilia or coagulopathy
• History of thromboembolic events
• Severe cardiac/renal/liver disease
• Poorly controlled hypertension /severe preeclampsia (BP > 160/100)/eclampsia

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision, and Intravenous oxytocin 5 units post delivery of the baby.

Treatment:

Drug: Tranexamic acid

Control group

Placebo Comparator group

Description:

Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby

Treatment:

Drug: Normal saline