Not yet recruitingPHASE3INTERVENTIONAL

Optimizing the Use of Aspirin for the Prevention of Preeclampsia

This study is investigating if pregnant women who are at a higher risk of developing a condition called pre-eclampsia can safely stop taking low-dose aspirin earlier in their pregnancy. Currently, many high-risk women take aspirin until close to their due date. Aspirin helps prevent pre-eclampsia by supporting the baby's development in early pregnancy. It's not clear if continuing aspirin into later pregnancy offers extra benefits. This study hopes to find out if stopping aspirin between 24 and 28 weeks of pregnancy is just as effective as continuing until 36 weeks. It will also look at whether this is true for women from different backgrounds, including those of African origin where pre-eclampsia is more common.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Enrolment target

15,160

Start

01 Jul 2026

Estimated completion

01 May 2028

Preeclampsia

What is this study about?

When you're pregnant, a small number of women might develop a condition called pre-eclampsia. This can lead to high blood pressure and other problems for both mum and baby. To help prevent this, doctors sometimes recommend that pregnant women who are at a higher risk take a low dose of aspirin every day.

At the moment, women identified as high-risk typically take aspirin from early pregnancy until about 36 weeks. We know that aspirin mainly helps during the first half of pregnancy by helping the placenta (the organ that provides food and oxygen to the baby) to develop well. However, it's not clear if continuing to take aspirin after around 24 to 28 weeks of pregnancy offers any extra protection. Many women who take aspirin because they're thought to be at high risk for pre-eclampsia might not actually develop the condition. This means they could be taking aspirin for longer than needed, and like any medicine, aspirin can have side effects, such as a slightly increased risk of bleeding.

This study aims to discover if it's safe and effective for high-risk pregnant women to stop taking aspirin earlier, specifically between 24 and 28 weeks, compared to the usual practice of continuing until 36 weeks. Researchers will collect information from many women across different countries to understand if the shorter treatment is just as good at preventing pre-eclampsia. This is particularly important for a wide range of women, including those of African descent, who may have a higher natural risk of pre-eclampsia. The results could help doctors decide on the best and safest aspirin treatment plans for pregnant women in the future.

Key takeaways

Study looks at safer, shorter aspirin use for pre-eclampsia.
Compares stopping aspirin at 24-28 weeks vs. 36 weeks.
Aims to see if earlier stopping is just as effective.
Helps understand aspirin use for diverse groups, including African women.
You might have extra tests if you participate.
You can stop participating at any time.

Who may be eligible?

This study is looking for pregnant women who are at least 18 years old. You must be expecting one baby (not twins or more) and be able to understand the study information.

To be eligible, you would have already had a special screening test in your first trimester (between 11 and 14 weeks) that showed you are at a higher risk for pre-eclampsia. You should also already be taking a daily low dose of aspirin (150 mg) because of this high-risk result. You need to be willing to sign a consent form, agree to follow all study instructions, and be happy with your assigned treatment plan (either stopping aspirin early or continuing it longer). This might involve having some extra blood tests and ultrasound scans.

However, you won't be able to join if you've sadly experienced serious pregnancy complications early on, or if your baby has known serious health problems. Also, if you're allergic to aspirin, or have any other medical conditions that mean stopping aspirin would be unsafe for you (for example, if you need aspirin for a heart condition), then this study wouldn't be suitable.

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 18 years or older and currently pregnant with one baby?
Did your first-trimester screening show you're at high risk for pre-eclampsia?
Are you currently taking 150 mg of aspirin daily for this reason?
Do you have any known allergies to aspirin or other medical conditions that mean you can't stop taking it?
Are you willing to have additional tests and follow the study's assigned treatment plan?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly put into one of two groups, like flipping a coin. One group will be asked to stop taking your daily low-dose aspirin (150 mg) when you are between 24 and 28 weeks pregnant. The other group will continue taking your low-dose aspirin every day until you are 36 weeks pregnant. You won't know which group you're in until it's decided.

During the study, you'll continue with your regular antenatal appointments. You might also be asked to have some additional blood tests and ultrasound scans at certain times throughout your pregnancy. Researchers will keep track of your health and your baby's health to see how you both are doing. The study will continue until after your baby is born, and researchers will follow up on any health events for both you and your baby. The total duration of your active participation will be from the time you join until after your baby is born, likely a few weeks post-delivery.

Potential risks and benefits

Taking part in this study may offer some benefits, such as contributing to new knowledge that could help future pregnant women. If you are in the group that stops aspirin earlier, you might avoid potential side effects of prolonged aspirin use, including a small risk of bleeding. The main risk involved is that if stopping aspirin early is found to be less effective, you could potentially have a slightly increased risk of developing pre-eclampsia compared to continuing it longer. However, the study is designed to carefully monitor all participants for their safety, and a similar study among mainly European women suggested that stopping early was just as safe. Remember, your participation is completely voluntary; you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (38)

Medical University of Vienna
Verified postcode
Vienna, Austria
St Josef Hospital
Verified postcode
Vienna, Austria
Dr Shterev Hospital
Verified postcode
Sofia, Bulgaria
Saint Patrick Hospital
Verified postcode
Ofinso, Ghana
Holy Family Hospital
Verified postcode
Techiman, Ghana
Hopital Phillipe Senghor
Verified postcode
Dakar, Senegal
Centre Hospitalier Régional de Saint-Louis
Verified postcode
Saint-Louis, Senegal
Hospital San Cecilio
Verified postcode
Granada, Spain
Hospital Universitari Dexeus
Verified postcode
Barcelona, Spain
Hospital Dr.Josep Trueta
Verified postcode
Girona, Spain
Hospital Joan XXIII
Verified postcode
Tarragona, Spain
Hospital de Cruces
Verified postcode
Barakaldo, Spain

Common questions

What is pre-eclampsia?

Pre-eclampsia is a condition that can happen in pregnancy, causing high blood pressure and other problems for the mother and baby, usually after 20 weeks.

Why is aspirin used for pre-eclampsia?

Low-dose aspirin can help prevent pre-eclampsia by improving how the placenta (your baby's life support) develops in early pregnancy.

Will I know which treatment group I'm in?

Yes, once you're assigned to a group (either stopping aspirin early or continuing it), you will know which plan you are following.

Are there any extra doctor visits required?

You'll have your usual antenatal checks, but might have a few extra blood tests and ultrasound scans specific to the study.

What if I take aspirin for another medical condition?

If you need aspirin for other medical reasons, this study would likely not be suitable for you as stopping it could be unsafe.

How to find out more

Manel Mendoza Cobaleda, Professor

manel.mendoza@vallhebron.cat +34 93 489 30 00 Official trial record

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