RecruitingPHASE3INTERVENTIONAL

TRAnexamic Acid for Preventing Blood Loss Following a Cesarean Delivery in Women With Placenta pREVIA

This study is looking at whether a common medicine called tranexamic acid (TXA) can effectively prevent heavy bleeding (called postpartum hemorrhage) after a C-section. It's specifically for women who have a condition called placenta previa, which puts them at a higher risk of losing a lot of blood during delivery. Previous smaller studies suggested TXA might help, but they didn't include women with placenta previa. This larger study aims to properly test if TXA, given during a C-section, can reduce blood loss in these higher-risk mothers. Half the women will receive TXA, and the other half will receive a dummy drug (placebo), without anyone knowing who gets what until after the study.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Bordeaux

Enrolment target

1,380

Start

07 Aug 2020

Estimated completion

01 Sep 2027

Postpartum Hemorrhage

What is this study about?

When a woman gives birth by C-section, especially if she has a condition called placenta previa (where the placenta is low in the womb), there's a risk of losing a lot of blood. Heavy bleeding after childbirth is a serious concern for mothers.

Doctors have used a medicine called tranexamic acid, or TXA, for many years to help stop bleeding in various surgeries and even after childbirth in other situations. It works by helping the blood clot. Smaller studies have shown that giving TXA during a C-section might reduce blood loss, but these studies didn't include women who are at a higher risk of bleeding, like those with placenta previa.

This study aims to find out if TXA can safely and effectively prevent heavy bleeding in women with placenta previa who are having a C-section. It's designed to be a large, well-organised study to give doctors clear answers on whether to recommend TXA for these mothers. Knowing this could help improve the safety of C-sections for women at higher risk.

Key takeaways

This study is testing a medicine called tranexamic acid (TXA) for preventing heavy bleeding during C-sections in women with placenta previa.
Women with placenta previa are at higher risk of bleeding, and this study aims to see if TXA can make their deliveries safer.
You might receive TXA or a dummy drug; neither you nor your doctors will know which one.
Participation involves receiving the study drug during your C-section and having your health monitored.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with placenta previa before your delivery. You also need to be having a C-section and be at least 32 weeks pregnant. You must be able to give your informed consent, meaning you understand the study and agree to take part.

There are certain reasons why you wouldn't be able to join. These include if you have a history of blood clots, certain heart, kidney, or liver problems, epilepsy, or specific blood clotting disorders. If you're suspected of having a more serious placenta condition (placenta accreta), or if you’ve already lost a lot of blood just before your C-section, you wouldn't be able to participate. Also, if you have conditions like eclampsia or a fetal death in the womb, you wouldn't be eligible.

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 18 years old?
Have you been diagnosed with placenta previa before delivery?
Are you scheduled for or having a C-section?
Are you at least 32 weeks pregnant?
Do you have a history of blood clots or severe heart/kidney/liver problems?
Do you have any specific bleeding or clotting disorders?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be assigned to one of two groups by chance, like flipping a coin. One group will receive tranexamic acid, and the other will receive a harmless saltwater solution (a placebo). Neither you nor your doctors will know which treatment you receive until after the study is over. Both treatments are given through a drip (intravenously) during your C-section.

Your participation involves giving your informed consent. Doctors will closely monitor your blood loss during and after your C-section, and collect information about your health. There will be no extra visits or tests beyond your usual maternity care. The total duration of your active participation would be during your C-section and immediate recovery, and your health information would be collected as part of the study.

Potential risks and benefits

The potential benefit of taking part is that tranexamic acid, if it works as hoped, could help reduce your risk of heavy bleeding during and after your C-section. This could lead to a safer delivery and quicker recovery. However, there's no guarantee you'll receive the active drug or that it will help in your specific case. Like all medicines given through an IV, tranexamic acid can have side effects, though serious ones are rare. These can include nausea, vomiting, diarrhoea, and less commonly, blood clots. If you have any concerns or experience unwanted effects, you should tell your care team immediately. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is placenta previa?

Placenta previa is when the placenta is very low in the womb and covers part or all of the cervix, which can cause heavy bleeding during or after birth.

What is tranexamic acid (TXA)?

TXA is a medicine that helps your blood clot. It's often used to reduce bleeding during or after surgery, and in some cases of heavy periods.

Why is this study important for women with placenta previa?

Women with placenta previa are at a higher risk of heavy bleeding during a C-section. This study aims to find out if TXA can specifically help these women have safer deliveries by reducing blood loss.

Will I know if I'm getting the medicine or the dummy drug?

No, this is a 'blinded' study, meaning neither you nor your doctors will know if you're getting TXA or a dummy drug (placebo) until the study is over. This helps make the study results more reliable.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care in any way.

How to find out more

Loic Sentilhes, MD, PhD

loic.sentilhes@chu-bordeaux.fr +335 56 79 55 79 Official trial record

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