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Use of TXA to Prevent Postpartum Hemorrhage

NCT03069859 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2022-09-13

No results posted yet for this study

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

Interventions

DRUG

TXA (1g)

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

DRUG

Placebo (0.9% saline)

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

Sponsors & Collaborators

  • Sunnybrook Health Sciences Centre

    lead OTHER

Principal Investigators

  • Asim Q Alam, MD, FRCPC · Sunnybrook Health Sciences Centre

  • Stephen Choi, MD,FRCPC,MSc · Sunnybrook Health Sciences Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2019-12-01
Completion
2022-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03069859 on ClinicalTrials.gov