Use of TXA to Prevent Postpartum Hemorrhage

NCT03069859 | Unknown Phase 2 DMC

• 1 other identifier: 418-2016
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Partum Hemorrhage

Keywords

Post partum hemorrhage; Tranexamic acid; Spontaneous vaginal delivery; C-section

Outcome Measures

Primary Outcomes (1)

• Number of patients receiving study intervention

  Proportion of patients receiving study intervention (IP) after randomization

  At time of delivery

Secondary Outcomes (4)

• Duration of study to recruit 58 participants

  Up to 4 months

• Proportion of budget needed to recruit 58 participants

  Up to 4 months

• Composite number of clinical events

  At 6 week (+/- 14 days) and 12 week (+/- 14 days) follow-ups assessments

• Incidence of PPH in study participants

  Up to 4 months

Study Arms (2)

TXA (1g)

EXPERIMENTAL

For vaginal, TXA (1g) will be administered upon delivery of the anterior shoulder. For c-section, TXA (1g) will be administered when the obstetrician begins to cleanse the incision site

Drug: TXA (1g)

Placebo (0.9% saline)

PLACEBO COMPARATOR

For vaginal, placebo (0.9% saline) will be administered upon delivery of the anterior shoulder. For c-section, placebo (0.9% saline) will be administered when the obstetrician begins to cleanse the incision site

Drug: Placebo (0.9% saline)

Interventions

TXA (1g) DRUG

1 gram of TXA (10 mL) diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)

Also known as: TXA

TXA (1g)

Placebo (0.9% saline) DRUG

0.9% saline (10 mL), diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)

Also known as: Placebo

Placebo (0.9% saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Singleton pregnancy
• Confirmed pregnancy
• Gestational age \>32\^0/7 weeks

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (33)

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MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Asim Q Alam, MD, FRCPC

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Stephen Choi, MD,FRCPC,MSc

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2017
• First Posted: March 3, 2017
• Study Start: March 6, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)