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

Postpartum Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427618
• Other study ID #: 2019/2425
• Status: Completed
• Phase: Phase 3
• Start date: June 23, 2020
• Est. completion date: February 1, 2022

Study information

• Verified date: August 2021
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: February 1, 2022
• Est. primary completion date: October 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage
• Tranexamic Acid

Intervention

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

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Need for additional medical intervention including blood transfusion, additional uterotonics		During surgery and up to 3 days after surgery
Secondary	Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery		During surgery and up to 24 hours from surgery
Secondary	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
Secondary	Neonatal APGAR score	Neonatal APGAR score at 1 and 5 minutes of life	At delivery
Secondary	Neonatal birth weight		At delivery
Secondary	Neonatal admission to special care nursery or intensive care unit		At delivery
Secondary	Diagnosis of thromboembolic events in the neonate		Up to 4 weeks post delivery
Secondary	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
Secondary	Provider estimated blood loss	Estimated by the surgical team	Intraoperative