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

NCT04427618 | Completed Phase 3 DMC

• 1 other identifier: 2019/2425
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in hemoglobin and hematocrit level

  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

  Intraoperative to 4 weeks post surgery

• Neonatal APGAR score

  At delivery

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Tranexamic acid DRUG

Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision

Intervention group

Normal saline DRUG

Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision

Control group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

Location

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Manisha Mathur

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2020
• First Posted: June 11, 2020
• Study Start: June 23, 2020
• Primary Completion: October 3, 2021
• Study Completion: February 1, 2022
• Last Updated: November 9, 2022

Record last verified: 2021-08

Locations

SG (1)