Skip to main content
OpenTrials
Completed

NCT Number: NCT04427618

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

KK Women's and Children's Hospital

Singapore

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

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

normal saline

Drug

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

Primary outcomes

  1. Estimated blood loss

    Time frame: Intraoperative

    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.

Secondary outcomes

  1. Change in hemoglobin and hematocrit level

    Time frame: Preoperative to 48 hours postoperative

    Comparison of full blood count results prior to surgery and within approximately 48 hours post surgery

  2. Need for additional medical intervention including blood transfusion, additional uterotonics

    Time frame: During surgery and up to 3 days after surgery

  3. Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery

    Time frame: During surgery and up to 24 hours from surgery

  4. Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism

    Time frame: Intraoperative to 4 weeks post surgery

    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.

  5. Neonatal APGAR score

    Time frame: At delivery

    Neonatal APGAR score at 1 and 5 minutes of life

  6. Neonatal birth weight

    Time frame: At delivery

  7. Neonatal admission to special care nursery or intensive care unit

    Time frame: At delivery

  8. Diagnosis of thromboembolic events in the neonate

    Time frame: Up to 4 weeks post delivery

  9. Gravimetric estimation of blood loss during the surgery

    Time frame: Intraoperative

    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

  10. Provider estimated blood loss

    Time frame: Intraoperative

    Estimated by the surgical team

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jun 11, 2020
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.