Clinical trial NCT03069859: Use of TXA to Prevent Postpartum Hemorrhage
Official title: Prophylactic Use of Tranexamic Acid for Preventing Postpartum Hemorrhage: A Randomized, Double-blinded, Placebo-controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post Partum Hemorrhage
Keywords: Post partum hemorrhage
Tranexamic acid
Spontaneous vaginal delivery
C-section
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: This pragmatic, singlecentered, doubleblinded, randomized-controlled pilot trial will assess the feasibility of administering a prophylactic dose of TXA to prevent the onset of PPH amongst parturients undergoing cesarean section and spontaneous vaginal delivery. Our primary outcome will be to determine the proportion of patients who receive the investigational product successfully. Our secondary outcomes include 1) additional feasibility endpoints; 2) safety endpoints and 3) various other clinical endpoints. These clinical endpoints include a) incidence of PPH (and severe PPH); b) total number of transfusions; c) use of uterotonic drugs; and d) hospital length of stay. The investigators anticipate that TXA can be safely administered to parturients prior to delivery. The investigators also believe it will be an effective prophylactic therapy for PPH and will reduce its severity and associated morbidity. Results from this trial will be used to design and conduct a larger multicentered trial, powered to assess the outcomes of interest. Furthermore, this prophylactic use of TXA for PPH could improve outcomes of parturients not only in Ontario but worldwide where effective management of PPH remains an ongoing challenge.

Eligibility 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

Primary outcomes:
measure: Number of patients receiving study intervention
timeFrame: At time of delivery
Secondary outcomes:
measure: Duration of study to recruit 58 participants
timeFrame: Up to 4 months
measure: Proportion of budget needed to recruit 58 participants
timeFrame: Up to 4 months
measure: Composite number of clinical events
timeFrame: At 6 week (+/- 14 days) and 12 week (+/- 14 days) follow-ups assessments
measure: Incidence of PPH in study participants
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Asim Q Alam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Stephen Choi, MD,FRCPC,MSc
role: PRINCIPAL_INVESTIGATOR
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