Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A prospective interventional randomized controlled trial to assess the effect of low dose acetylsalicylic acid as a preventive treatment of preeclampsia in pregnant women who underwent frozen embryo transfer

This research is a study for pregnant women who became pregnant through frozen embryo transfer. It's looking into whether taking a small dose of aspirin, specifically 80mg, can help prevent a serious pregnancy condition called pre-eclampsia. Pre-eclampsia involves high blood pressure and can affect both the mother and baby. The study will compare women who take this small dose of aspirin with women who don't, to see if the aspirin group has fewer cases of pre-eclampsia. This is a large study (Phase III) designed to find out for certain if this treatment works. The aim is to make future pregnancies safer for women like you.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire De Liege

Enrolment target

276

Start

12 Sep 2024

preeclampsia

What is this study about?

This study is focused on a pregnancy condition called pre-eclampsia. Pre-eclampsia is when a pregnant woman develops high blood pressure and other signs like protein in her urine, usually after 20 weeks of pregnancy. It can be serious for both the mother and the baby, and in some cases, it means the baby needs to be delivered early. We already know that women who become pregnant through frozen embryo transfer might have a slightly higher chance of developing pre-eclampsia.

Researchers want to see if taking a small daily dose of aspirin (acetylsalicylic acid) could help prevent pre-eclampsia in these pregnancies. Aspirin is a common medication that can help thin the blood and reduce inflammation. In this study, some women will be given a specific 80mg aspirin tablet, while others will not, and doctors will compare how many women in each group develop pre-eclampsia.

This is a 'Phase III' study, which means it's a large, important trial designed to confirm if a new treatment is really effective and safe before doctors can generally recommend it. The goal is to provide clear answers about whether low-dose aspirin can make a real difference in preventing pre-eclampsia for pregnant women who have had frozen embryo transfer, ultimately aiming to improve pregnancy outcomes.

Key takeaways

A study for pregnant women after frozen embryo transfer.
Investigating if low-dose aspirin can prevent pre-eclampsia.
Compares aspirin to no aspirin, with careful monitoring.
Aims to improve pregnancy outcomes for mothers and babies.
Participation involves regular check-ups and taking a daily tablet (or not).

Who may be eligible?

This study is specifically for pregnant women. To be considered, you must be at least 18 years old – there's no upper age limit mentioned. The most important factor is that you became pregnant after having a frozen embryo transfer.

Before you can join, the study team will ask you some questions about your health and your pregnancy. This is to make sure the study is right for you and that it's safe for you to take part. They will also make sure your particular situation fits the study's requirements.

They're looking for women whose pregnancies are at a stage where the aspirin treatment could potentially be beneficial for preventing pre-eclampsia. If you're interested, the research team will explain all the details and check if you meet all the necessary criteria.

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 pregnant?
Are you 18 years old or older?
Did you become pregnant through frozen embryo transfer?
Are you willing to potentially take a daily aspirin tablet or be in a group that doesn't?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to one of two groups. One group would receive a daily low-dose aspirin tablet (80mg, designed to protect your stomach), and the other group would not receive aspirin. You wouldn't know which group you are in, and neither would the study doctors. You would take the medication (or not) throughout a certain part of your pregnancy.

You would have regular visits with the study team, similar to your routine antenatal appointments, but with some extra checks. These check-ups would include monitoring your blood pressure, urine, and general health to keep an eye out for any signs of pre-eclampsia or other changes. The study doctors and nurses would also keep track of your and your baby's health throughout the pregnancy and after birth. The duration of your participation would cover the period of medication use, your pregnancy, and potentially a follow-up after delivery.

Potential risks and benefits

Taking part in this study could potentially be beneficial if the low-dose aspirin proves to prevent pre-eclampsia, leading to a healthier pregnancy for you and your baby. However, there's no guarantee the treatment will work for everyone, and you might be in the group that doesn't receive aspirin. All medications, including aspirin, can have side effects, although low-dose aspirin is generally considered safe in pregnancy. Potential risks might include mild indigestion or, very rarely, more serious issues like bleeding. The study team will carefully monitor you for any side effects. You are always free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Belgium

Common questions

What is pre-eclampsia?

Pre-eclampsia is a pregnancy condition that causes high blood pressure and can affect your organs, usually developing after 20 weeks of pregnancy. It needs careful medical attention.

Why is this study looking at women who had frozen embryo transfer?

Research suggests that women who become pregnant through frozen embryo transfer might have a slightly higher chance of developing pre-eclampsia, so this study is specifically looking at how to help this group.

What is 'low-dose aspirin'?

Low-dose aspirin in this study is a small, 80mg tablet designed to help prevent blood clots and reduce inflammation, rather than just relieving pain.

Will I know if I'm taking the aspirin or not?

No, you won't. This is a 'blinded' study, meaning neither you nor your doctors will know which group you are in to keep the results unbiased.

What if I change my mind about participating?

You are free to stop participating in the study at any time, for any reason, and it will not affect the medical care you receive.