Use of TXA to Prevent Postpartum Hemorrhage

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

Postpartum hemorrhage (PPH) occurs in up to one in ten deliveries worldwide and is the leading cause of maternal morbidity and mortality. In developing countries 30% of women develop PPH because access to a number of treatments is not readily available. Interestingly, the rate of PPH and consequently of maternal morbidity has increased significantly even in developed nations, such as Canada, over the past decades. This rate is also increasing amongst parturients in Ontario. Unfortunately, few effective preventative treatments exist.

Antifibrinolytic drugs are routinely used to reduce bleeding and the requirement for blood transfusions in a wide range of hemorrhagic conditions. The most commonly used antifibrinolytic drug is tranexamic acid (TXA). TXA is safe, affordable, with very few side effects. The World Health Organization recommended that TXA be used to reduce blood loss in several conditions, including in patients with established PPH refractory to conventional therapy.However, little is known about the prophylactic use of TXA to prevent PPH.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunnybrook Health Sciences Centre
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• 18 years of age or older

• Singleton pregnancy

• Confirmed pregnancy

• Gestational age >32^0/7 weeks

Exclusion Criteria:

• Lack of patient consent

• Multiple pregnancy

• History of eclampsia or preeclampsia in current pregnancy

• Imminent Delivery as suspected by any RN or MD involved in delivery care

• History of cardiovascular complications:

• Coronary artery disease or myocardial infarction

• Repaired or unrepaired congenital heart disease

• Vascular disease(s)

• Severe unstable arrhythmia (e.g. Rapid atrial fibrillation, paroxysmal fibrillation, atrial flutter, etc.)

• Congestive heart failure

• Contraindication to TXA:

• History of venous thromboembolism

• Active thromboembolic disease

• High risk of thrombosis (e.g. Factor V Leiden or Protein C deficiency)

• Acquired disturbances of colour vision

• Allergy to TXA

• History of seizure disorder

• Pre-existing hematuria

• History of renal insufficiency

• Unlikely to comply with follow-up (e.g. no fixed address, plans to move out of town)

• Prisoner status