RecruitingOBSERVATIONAL

Early Prediction of Preeclampsia Using arteriaL Stiffness in High-risk prEgnancies

This study, called PULSE, aims to find new, earlier ways to predict pre-eclampsia, a serious pregnancy complication. Even with modern care, pre-eclampsia can cause health problems for both mothers and babies. Instead of just treating symptoms once they appear, the study focuses on spotting the condition sooner. Researchers are using a simple, non-invasive test that measures how stiff your blood vessels are, along with blood tests, detailed scans, and questionnaires. The goal is to see if this combination can identify women at high risk much earlier. This could change how we manage and treat pre-eclampsia, potentially improving outcomes for many families.

At a glance

Status

Recruiting

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

2,400

Start

12 Jul 2021

Estimated completion

01 Jan 2027

High Risk Pregnancy Arterial Stiffness Pre-Eclampsia

What is this study about?

Pre-eclampsia is a serious health issue that can affect some pregnant women. It can lead to severe complications for both the mother and the baby, and can even have long-term health effects for the mother, like a higher risk of heart problems later in life. Unfortunately, it's still a leading cause of illness and death for mothers and babies around the world.

Currently, the ways we predict pre-eclampsia aren't always perfect. The condition often starts weeks or months before any clear symptoms show up. This study, called PULSE, is designed to take advantage of this early stage. Instead of waiting for symptoms to develop, researchers want to find new tools that can spot the early warning signs much sooner. This would allow doctors to identify and help women at risk earlier than before.

What makes this study special is its focus on a preventative approach. Researchers will be looking at a non-invasive test that measures something called "arterial stiffness" – essentially, how flexible your blood vessels are. This test, combined with blood tests, detailed ultrasound scans, and questions about your physical and mental health, makes this the largest and most detailed study of its kind. The results could hugely improve how we manage pre-eclampsia and help doctors provide better care to high-risk pregnant women in the future.

Key takeaways

This study aims to find new, earlier ways to predict pre-eclampsia.
It uses a non-invasive test for 'arterial stiffness' alongside other routine checks.
The goal is to improve care for pregnant women at high risk of pre-eclampsia.
You would have two study visits during your pregnancy for measurements and questionnaires.
Your involvement helps contribute to vital research for future mothers and babies.

Who may be eligible?

This study is looking for pregnant women who are carrying one baby only and are still in the early stages of pregnancy (up to 14 weeks).

To be eligible, you must have at least one significant risk factor for pre-eclampsia, or two moderate risk factors. Your doctor can help you understand if you meet these criteria.

However, you won't be able to join if you're carrying more than one baby, are past 14 weeks of pregnancy, or have certain existing medical conditions like heart disease, a history of stroke, or some infectious diseases like Hepatitis B/C, HIV, or COVID-19.

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 currently pregnant with one baby?
Are you less than 14 weeks pregnant?
Do you have any risk factors for pre-eclampsia (your doctor can advise)?
Do you have a healthy heart and no history of stroke or circulation problems?
Do you not have infectious diseases like Hepatitis B/C, HIV, or active COVID-19?

Answer every question to see your result.

What does participation involve?

If you join this study, your participation will last during your pregnancy and for a short time after birth. You would have two appointments during your pregnancy:

* **First visit:** This will be between 10 and 13 weeks of your pregnancy. Here, you'll have measurements taken of your blood vessels (checking arterial stiffness and blood pressure), blood samples taken, and you'll complete questionnaires about your lifestyle and feelings. * **Second visit:** This will be between 18 and 21 weeks of your pregnancy. This visit will be similar to the first, but will also include a special ultrasound called a Uterine Artery Doppler, which looks at blood flow to the womb.

After your baby is born, once you're 6 to 8 weeks postpartum, the study team will gather information from your medical records about your pregnancy outcomes. No additional visits are needed after you've given birth. No specific medication is involved in this study; it's purely for observation and gathering information.

Potential risks and benefits

Taking part in this study may offer the benefit of contributing to important scientific knowledge that could help future pregnant women and their babies. While there are no direct medical benefits to you personally from the tests, as they are for research purposes, your participation helps us understand pre-eclampsia better. The procedures involved, such as blood tests and blood pressure measurements, are standard and carry minimal risks, similar to routine antenatal care. The arterial stiffness test is non-invasive and painless. You are free to withdraw from the study at any time, for any reason, without affecting your regular medical care.

Locations (1)

Royal Victoria Hospital
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is pre-eclampsia?

Pre-eclampsia is a serious pregnancy complication that can cause high blood pressure and damage to organs like the kidneys and liver.

Why is early prediction important?

Spotting pre-eclampsia early means doctors can monitor you more closely and provide care sooner, which can improve health outcomes for both you and your baby.

What is 'arterial stiffness'?

Arterial stiffness refers to how rigid your blood vessels are. It can be an early sign of changes that might lead to conditions like pre-eclampsia.

Are the tests risky?

The tests, like blood samples and blood pressure checks, are generally safe and similar to those you'd have during regular pregnancy appointments. The arterial stiffness test is non-invasive.

How long will my involvement last?

Your direct involvement for measurements and questionnaires will span two visits during your pregnancy, with medical record review up to 6-8 weeks after birth.

How to find out more

Helena Papacostas, PhD

helena.papacostas@rimuhc.ca 514 934-1934 Official trial record

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