Not yet recruitingPHASE4INTERVENTIONAL

Cardiac Changes After Effective Dose Carbetocin for Elective Caesarian Section

This research is investigating a common medicine called carbetocin, which is given to mothers during an elective caesarean section. Its main job is to help the womb contract and prevent heavy bleeding after birth. The study aims to find out if using a smaller dose of carbetocin (50 micrograms, or mcg) causes fewer heart-related side effects compared to the standard dose (100 mcg). Researchers will carefully compare how mothers feel, looking for any heart symptoms they report. They’ll also check heart activity using a test called an ECG and measure a protein in the blood called troponin, which can sometimes show if the heart has been under strain. By doing this, the study hopes to ensure that mothers receive the most effective dose of carbetocin with the fewest possible risks to their heart during what is already a significant event.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Jordan Leitch

Enrolment target

200

Start

01 Aug 2025

Estimated completion

01 Sep 2027

Cardiac Ischemia Cesarian Section

What is this study about?

This study is about a medicine called carbetocin, which is often given to mothers during a planned caesarean section. Its main role is to help stop too much bleeding after the baby is born by making the womb contract properly. While carbetocin is very helpful, sometimes it can cause temporary changes to the heart, which might make a mother feel a bit unwell or cause changes that doctors can see on a heart tracing.

Researchers want to see if using a lower dose of carbetocin (50 micrograms, often written as 50mcg) might be just as effective but cause fewer side effects for the heart compared to the usual dose (100mcg). They will be looking at a few different things: how mothers feel and if they notice any heart-related symptoms, changes in their heart's electrical activity shown on an ECG, and levels of a specific protein in their blood called troponin, which can go up if the heart has been under stress.

The main aim is to find out if reducing the dose of carbetocin can still do its job preventing bleeding, but be gentler on the mother's heart. This research is important because it could help doctors choose the safest and most effective dose of carbetocin for women having a planned caesarean section, making the experience as smooth and safe as possible for new mothers.

Key takeaways

This study is looking at a medicine called carbetocin, used in planned C-sections.
It compares two doses (50mcg and 100mcg) to see which is kinder to the heart.
Researchers will check heart symptoms, ECGs, and blood tests around your delivery.
The goal is to find the safest dose of carbetocin for mothers.
Participation is voluntary and won't affect your normal medical care.

Who may be eligible?

This study is looking for women who are planning to have a caesarean section. This can be your first caesarean or if you've had one before. You need to be at least 18 years old to take part.

However, there are some reasons why you might not be able to join. For example, if you already have heart problems, or have had them in the past, or if you have a condition called pre-eclampsia. Also, if your Body Mass Index (BMI) is over 50, or if you have a known problem with your blood clotting, you wouldn't be able to participate.

Finally, if you know you're allergic to carbetocin, this study wouldn't be suitable for you. The researchers want to make sure the study is safe for everyone involved, so they have these important checks in place.

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 having a planned caesarean section?
Are you 18 years old or older?
Do you have any heart problems or pre-eclampsia?
Is your BMI over 50?
Do you have problems with blood clotting?
Are you allergic to carbetocin?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the process will be quite simple and closely tied to your planned caesarean section. During your operation, you will be given one of two doses of carbetocin through a drip: either the usual dose (100mcg) or a lower dose (50mcg). You won't know which dose you're receiving.

After your baby is delivered and while you are recovering, you will be asked if you've experienced any heart-related symptoms. The medical team will also keep a close eye on your heart using an ECG machine, which is a standard procedure, and monitor how much blood you lose, just like they would for any caesarean section. Additionally, a blood sample will be taken to check for a protein called troponin, which helps doctors understand if your heart has been under any strain. There are no extra visits or long-term follow-ups specifically for this study beyond what would normally happen after a caesarean section. The entire study-related involvement happens around your delivery.

Potential risks and benefits

Taking part in this study might not directly benefit you, but the information found could help improve care for future mothers having a caesarean section. Potential risks are low as carbetocin is a commonly used medication. However, any medication can have side effects, and some heart-related changes have been seen with carbetocin, though these are usually temporary. Participants will be closely monitored for any such effects. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Kingston Health Sciences Centre
Verified postcode
Kingston, Canada

Common questions

What is carbetocin?

Carbetocin is a medicine given during a C-section to help your womb contract and prevent too much bleeding after your baby is born.

Why is this study important for me?

While it might not directly change your C-section, the study aims to make C-sections even safer for future mothers by finding the best dose of carbetocin for heart health.

What will happen if I take part?

You'll receive either a standard or lower dose of carbetocin during your C-section. Doctors will then check how you feel, monitor your heart, and take a blood test, just around the time of your delivery.

Will I know which dose I get?

No, you won't know if you're receiving the 50mcg or 100mcg dose. This helps ensure the study results are fair and unbiased.

What if I change my mind about participating?

You are free to withdraw from the study at any point, and your medical care will not be affected in any way.

How to find out more

Jordan Leitch, MD

jordan.leitch@kingstonhsc.ca 613-549-6666 Official trial record

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