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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage; Tranexamic Acid
• Intervention / Treatment: Drug: Tranexamic acid; Drug: Normal saline

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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.	Drug: Tranexamic acid; Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
Placebo Comparator: Control group; Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision, and intravenous oxytocin 5 units post delivery of the baby	Drug: Normal saline; Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss	This will be calculated estimated blood loss, defined as estimated blood volume x (preoperative hematocrit - postoperative hematocrit) ÷ preoperative hematocrit. Estimated blood volume in milliliters was calculated by body weight in kilograms x 85.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hemoglobin and hematocrit level	Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery	Preoperative to 48 hours postoperative
Need for additional medical intervention including blood transfusion, additional uterotonics		During surgery and up to 3 days after surgery
Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery		During surgery and up to 24 hours from surgery
Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism	Patients will be reviewed for signs and symptoms of thromboembolic events. They will be reviewed daily post surgery in the ward as per routine protocol. Generally, all post caesarean section patients will be warded till post operative day 3. They will also have a routine follow up 4 weeks post surgery.	Intraoperative to 4 weeks post surgery
Neonatal APGAR score	Neonatal APGAR score at 1 and 5 minutes of life	At delivery
Neonatal birth weight		At delivery
Neonatal admission to special care nursery or intensive care unit		At delivery
Diagnosis of thromboembolic events in the neonate		Up to 4 weeks post delivery
Gravimetric estimation of blood loss during the surgery	This would be assessed by weighing the swabs and drapes as well as measuring the volume of suction aspirated once the amniotic fluid volume had been deducted	Intraoperative
Provider estimated blood loss	Estimated by the surgical team	Intraoperative

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Manisha Mathur, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2020
• Primary Completion (Actual): October 3, 2021
• Study Completion (Actual): February 1, 2022

Study Registration Dates

• First Submitted: June 7, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 2019/2425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No