RecruitingPHASE4INTERVENTIONAL

Rate of Tranexamic Acid Administration on Blood Pressure (RateTXA) Study.

This study, called RateTXA, is looking at how quickly a medicine called tranexamic acid (TXA) is given to pregnant women having a C-section. TXA is commonly used to help reduce bleeding after birth by helping blood to clot. However, there are some concerns that giving it too quickly might cause a drop in blood pressure. We want to see if giving TXA over 1 minute compared to 10 minutes makes any difference to a woman's blood pressure during the C-section. The study includes healthy pregnant women and aims to find the safest way to give this important medicine.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of British Columbia

Enrolment target

110

Start

30 Mar 2024

Estimated completion

30 Dec 2027

Healthy Participants

What is this study about?

When women have a baby, sometimes they can experience heavy bleeding after birth, which is called postpartum hemorrhage. Tranexamic acid (TXA) is a very important medicine used to help stop this bleeding by making blood clots stronger. It works by preventing these clots from breaking down too quickly.

While TXA is very effective, there have been some questions about how best to give it. Some reports suggest that if TXA is given into a vein too quickly, it might cause a sudden drop in blood pressure. Other issues like feeling sick (nausea), throwing up (vomiting), or temporary changes in vision have also been reported, though these might be due to the medicine itself rather than how fast it's given.

This study is being done to check if the speed at which TXA is given actually affects blood pressure. We will be looking at healthy pregnant women who are scheduled to have a C-section birth and will receive spinal anaesthesia. We want to find out if giving TXA over 1 minute has a different effect on blood pressure compared to giving it over 10 minutes. The aim is to make sure we understand the safest and most effective way to use this medicine for mothers.

Key takeaways

This study investigates the best way to give bleeding-control medicine during C-sections.
It compares giving tranexamic acid (TXA) over 1 minute vs. 10 minutes.
The main focus is on how the speed of TXA affects blood pressure.
Participation might help improve care for future mothers.
You will receive careful monitoring during and after your C-section.

Who may be eligible?

This study is looking for pregnant women who are at least 34 weeks pregnant and are planning to have a planned C-section under spinal anaesthesia. You must be at least 19 years old and generally healthy according to a an anaesthetic health check-up (called ASA Physical Status Class 2, which means you have mild health concerns that don't affect your daily life too much).

There are several reasons why you might not be able to join the study. For example, if you have high blood pressure, or if you've recently taken medicines for high blood pressure, or other medicines that can affect blood pressure (like some for anxiety or to help you relax). You also can't take part if you have ever had an allergic reaction to TXA or similar medicines.

We also can't include you if your C-section needs a different type of anaesthetic than a single spinal injection, such as general anaesthesia or an epidural. You must also be able to understand and speak English to give your permission and follow the study instructions properly. Finally, if you arrive very close to your scheduled C-section time, there might not be enough time to properly explain everything and complete the study procedures.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you at least 34 weeks pregnant?
Are you having a planned C-section under spinal anaesthesia?
Do you have a generally healthy medical record (ASA Class 2)?
Are you at least 19 years old?
Do you not have high blood pressure or take related medications?
Do you not have an allergy to TXA or similar medicines?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive tranexamic acid (TXA) during your C-section. This is a medicine that is often given to help prevent heavy bleeding. How quickly the TXA is given will be decided by chance – it will either be given over 1 minute or over 10 minutes. During and shortly after your C-section, your blood pressure will be carefully watched. The study team will take extra measurements of your blood pressure to see how it changes. Beyond receiving the TXA and extra blood pressure monitoring, your C-section and recovery will be very similar to what would normally happen. The total duration of your active involvement in the study will be during your C-section and the immediate recovery period.

Potential risks and benefits

Taking part means you'll contribute to important research that could improve care for other mothers in the future by helping us understand the best way to give TXA. For you, there are no immediate personal benefits beyond the standard care you would receive. The main risk is a potential temporary drop in blood pressure, or other side effects like feeling sick, throwing up, or temporary vision changes, although these are generally mild. You are completely free to withdraw from the study at any time, for any reason, and this will not affect the quality of your care.

Locations (1)

BC Women's Hospital
Verified postcode
Vancouver, Canada· Recruiting

Common questions

What is Tranexamic Acid (TXA)?

It's a medicine used to help stop heavy bleeding by strengthening blood clots.

Why are you doing this study?

We want to find out if the speed at which TXA is given affects blood pressure during a C-section.

Will I know if I'm getting TXA fast or slow?

No, it will be decided by chance, and you won't know which group you are in during the procedure.

What happens if my blood pressure drops?

Your blood pressure will be closely monitored, and the medical team is ready to treat any drops immediately, as they would in any C-section.

Will taking part affect my C-section or baby?

The study aims for minimal impact; your C-section and the care for your baby will proceed as planned, with just extra blood pressure checks.

How to find out more

Aislynn Sharrock, BSc

aislynn.sharrock@cw.bc.ca 604-875-2424 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.