Use of TXA to Prevent Postpartum Hemorrhage (TAPPH-1)

September 12, 2022 updated by: Sunnybrook Health Sciences Centre

Prophylactic Use of Tranexamic Acid for Preventing Postpartum Hemorrhage: A Randomized, Double-blinded, Placebo-controlled Pilot Trial

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.

Study Overview

Status

Active, not recruiting

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.

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Toronto, Ontario, Canada, M4N3M5
        • Sunnybrook Health Sciences Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: TXA (1g)
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
1 gram of TXA (10 mL) diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)
Other Names:
  • TXA
PLACEBO_COMPARATOR: Placebo (0.9% saline)
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
0.9% saline (10 mL), diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients receiving study intervention
Time Frame: At time of delivery
Proportion of patients receiving study intervention (IP) after randomization
At time of delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of study to recruit 58 participants
Time Frame: Up to 4 months
Total time required to recruit and randomize 58 patients
Up to 4 months
Proportion of budget needed to recruit 58 participants
Time Frame: Up to 4 months
Cost required to recruit and randomize 58 patients
Up to 4 months
Composite number of clinical events
Time Frame: At 6 week (+/- 14 days) and 12 week (+/- 14 days) follow-ups assessments
Clinical events (adverse events) such as thrombotic complications, acute renal failure, seizure, not related to a diagnosis of preeclampsia or eclampsia, receipt of mechanical ventilation and ICU admission, death, minor side effects, thrombotic complications (as listed above) in the newborn, rates of acute renal failure in the newborn, seizures in the newborn at 24-48 hours will be documented to assess for the overall safety of this trial
At 6 week (+/- 14 days) and 12 week (+/- 14 days) follow-ups assessments
Incidence of PPH in study participants
Time Frame: Up to 4 months
Incidence of PPH or severe PPH in study participants
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Asim Q Alam, MD, FRCPC, Sunnybrook Health Sciences Centre
  • Principal Investigator: Stephen Choi, MD,FRCPC,MSc, Sunnybrook Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 6, 2018

Primary Completion (ACTUAL)

December 1, 2019

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

February 6, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (ACTUAL)

March 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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