Effect of Tranexamic Acid Administration Rates on Blood Pressure in Pregnant Women

The Effect of Tranexamic Acid Rate of Administration on Blood Pressure in Healthy Pregnant Women Scheduled for Elective Cesarean Delivery Under Spinal Anesthesia - A Prospective, Randomized, Double-blind, Non-inferiority Trial.

This study tests whether giving tranexamic acid quickly or slowly affects blood pressure in healthy pregnant women having a cesarean delivery.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 19 Years and up
• Sex: Female
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT06356948 on ClinicalTrials.gov

What this trial studies

This study investigates how different rates of tranexamic acid administration affect blood pressure in healthy pregnant patients undergoing elective cesarean delivery. Participants will receive tranexamic acid either over 1 minute or 10 minutes to assess any changes in blood pressure. The study aims to clarify the safety and efficacy of tranexamic acid administration in this specific patient population, particularly in relation to the risk of hypotension. By adhering to the World Health Organization's guidelines, the research seeks to optimize treatment protocols for post-partum hemorrhage.

Who should consider this trial

Good fit: Ideal candidates are pregnant women at least 34 weeks gestational age scheduled for elective cesarean delivery under spinal anesthesia.

Not a fit: Patients with a history of hypertension or those taking medications that affect blood pressure may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to safer administration practices of tranexamic acid, reducing the risk of hypotension during cesarean deliveries.

How similar studies have performed: Previous studies have explored the effects of tranexamic acid but this specific approach to administration rates is novel.

Eligibility criteria

Inclusion Criteria:

* Pregnant patients ≥34 weeks gestational age, for elective cesarean delivery under single-shot spinal anesthesia.
* American Society of Anesthesiologists (ASA) Physical Status Class 2.
* Patients ≥19 years of age.

Exclusion Criteria:

* Known history of pre-existing hypertension or hypertension disorders of pregnancy.
* Having recently taken a medication to treat high blood pressure (e.g. labetolol, hydralazine, nifedipine)
* Having recently taken a medication that could alter blood pressure, which could include beta those prescribed for anxiety (e.g. propranolol) or sedative pre-medication (e.g. midazolam, lorazepam).
* Known allergic reaction or hypersensitivity to TXA or any other TXA homologue.
* Elective cesarean delivery requiring general anesthesia or a neuraxial technique other than a single-shot spinal (e.g. Epidural or Combined Spinal Epidural).
* Patients who are unable to give informed consent due to a language barrier as the study team only speaks English and will be unable to complete consent process and study procedure appropriately.
* Patients arriving late to the surgical day care with \<90 min prior to scheduled cesarean delivery time resulting in potential delay for the operating room or inadequate time for consent and full execution of the protocol.

Where this trial is running

Vancouver, British Columbia

• BC Women's Hospital — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Anton Chau, MD MMSc — Department of Anesthesia BC Women's Hospital
• Study coordinator: Aislynn Sharrock, BSc

Conditions: Healthy Participants, tranexamic acid, infusion rate, post-partum hemorrhage, hypotension, cesarean delivery