Clinical trial NCT04427618: Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section
Official title: Tranexamic Acid in the Prevention of Postpartum Hemorrhage in Elective Caesarean Section: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Tranexamic Acid
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-11
Enrollment: 200
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Estimated blood loss
timeFrame: Intraoperative
Secondary outcomes:
measure: Change in hemoglobin and hematocrit level
timeFrame: Preoperative to 48 hours postoperative
measure: Need for additional medical intervention including blood transfusion, additional uterotonics
timeFrame: During surgery and up to 3 days after surgery
measure: Incidence of postpartum hemorrhage: defined as >1000ml total blood loss within 24 hours after delivery
timeFrame: During surgery and up to 24 hours from surgery
measure: Maternal thrombotic event such as deep vein thrombosis and pulmonary embolism
timeFrame: Intraoperative to 4 weeks post surgery
measure: Neonatal APGAR score
timeFrame: At delivery
measure: Neonatal birth weight
timeFrame: At delivery
measure: Neonatal admission to special care nursery or intensive care unit
timeFrame: At delivery
measure: Diagnosis of thromboembolic events in the neonate
timeFrame: Up to 4 weeks post delivery
measure: Gravimetric estimation of blood loss during the surgery
timeFrame: Intraoperative
measure: Provider estimated blood loss
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Manisha Mathur
role: PRINCIPAL_INVESTIGATOR
References: