RecruitingOBSERVATIONAL

Cardiometabolic Health in First Time Pregnancy

This study is investigating why certain pregnancy complications, such as high blood pressure and issues with the baby's growth, might increase a woman's chances of developing heart disease and diabetes many years later. Researchers want to compare women who have these complications with those who have healthy pregnancies. They'll follow women before, during, and after pregnancy to see how these conditions might affect their heart and blood sugar health. The goal is to learn more about these connections, so doctors can better prevent these health issues and potentially even stop these pregnancy complications from happening in the first place. Some women not planning pregnancy will also be included to help compare results.

At a glance

Status

Recruiting

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

3,500

Start

24 May 2023

Estimated completion

01 Dec 2052

Cardiometabolic Health Pregnancy Related Diabetes Placental; Syndrome, Dysfunction Heart Diseases

What is this study about?

This study is all about understanding the connection between certain pregnancy problems and a woman's long-term health. We know that some women experience complications during pregnancy, such as high blood pressure (called pre-eclampsia or gestational hypertension) or when the baby doesn't grow as much as expected. These issues are related to how the placenta, which feeds the baby, works.

Research has shown that women who have these pregnancy complications might be at a higher risk of developing conditions like heart disease and diabetes later in life. This study wants to explore this link in more detail. We want to find out if these pregnancy issues directly cause later health problems, or if they simply reveal that a woman might already be more prone to these conditions, even before she gets pregnant.

To do this, we'll be looking at women who are trying to get pregnant, following them through their pregnancy and for about a year after the baby is born. We'll check their risk factors for heart disease and diabetes at different points. We're also asking women who aren't planning to get pregnant to join the study, so we have a healthy comparison group. By understanding these connections better, we hope to find ways to reduce these health risks for mums and potentially prevent these pregnancy problems from happening in the future.

Key takeaways

This study looks at long-term health after certain pregnancy complications.
It aims to understand links between pregnancy issues and future heart disease/diabetes.
Participation involves health checks before, during, and after pregnancy (if applicable).
It helps future mothers by improving understanding and prevention.
No new treatments or medicines are involved in this study.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

This study is looking for women aged 18 to 45 years old.

If you're planning to get pregnant within the next year and haven't had a pregnancy past 20 weeks before, you might be able to join the 'pregnancy group'. We're also looking for women who are not planning to get pregnant in the next 18 months, who also haven't had a pregnancy past 20 weeks before, for our 'comparison group'.

There are some reasons why you wouldn't be able to join, such as if you're currently pregnant, undergoing fertility treatment, or if you have certain health conditions like type 1 diabetes, severe kidney disease, or a history of heart attack or stroke. We also can't include you if you have certain autoimmune diseases (like lupus) or are being treated for cancer. The study is specifically for individuals assigned female at birth.

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 between 18 and 45 years old?
Have you never been pregnant past 20 weeks before?
Are you actively trying to get pregnant within the next year (for the pregnancy group)?
Are you NOT planning pregnancy in the next 18 months (for the comparison group)?
Do you have good overall health, without serious existing conditions like Type 1 diabetes or severe kidney disease?
Are you able to agree to take part and understand the study information?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be followed closely over a period of time. If you're in the pregnancy group, this will involve checks before you get pregnant, during your pregnancy, and then again about 9 to 12 months after your baby is born. For the comparison group, you'll have similar checks over a longer period, but without the pregnancy-specific timings.

During your visits, researchers will collect information about your health. This might include measurements like your blood pressure, and samples like blood and urine. These checks are designed to help us understand your heart health and risk of diabetes. The study doesn't involve any new medications or treatments. The exact number and duration of visits will be explained in full detail if you're considering joining, and you'll always have the right to withdraw from the study at any time.

Potential risks and benefits

Taking part in this study won't offer a direct health benefit to you or your baby, as it's observational and doesn't involve new treatments. However, your participation will be incredibly valuable in helping researchers understand how certain pregnancy complications might affect women's health later in life. This knowledge could lead to better prevention strategies and care for future mothers. The main 'risks' involve the time commitment for appointments and the discomfort of blood tests, similar to routine medical checks. You will always have the right to withdraw from the study at any point without needing to give a reason, and this won't affect your medical care.

Locations (7)

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

Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Recruiting
NHS Greater Glasgow and Clyde
Verified postcode
Glasgow, United Kingdom· Recruiting
University College London Hospitals NHS Foundation Trust
Verified postcode
London, United Kingdom· Not yet recruiting
King's College Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Not yet recruiting
St George's University Hospitals NHS Foundation Trust
Verified postcode
London, United Kingdom· Not yet recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting
Manchester University NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Not yet recruiting

Common questions

What is 'cardiometabolic health'?

Cardiometabolic health refers to the health of your heart, blood vessels, and how your body processes sugar and fats. It involves conditions like heart disease, diabetes, and high blood pressure.

What are 'placental complications'?

These are problems during pregnancy linked to the placenta, which is the organ that provides nutrients and oxygen to your baby. Examples include high blood pressure during pregnancy (pre-eclampsia, gestational hypertension) and when the baby doesn't grow well (fetal growth restriction).

Will this study give me special treatment or medicine?

No, this study is about observing and understanding, not about giving new treatments or medicines. You'll continue to receive your usual antenatal care from your doctor or midwife.

How long will I be involved in the study?

If you join the pregnancy group, you'll be involved before, during, and for about a year after your pregnancy. If you join the comparison group, your involvement will span a similar overall time, but without pregnancy."

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Heike Templin

cuh.poppycctu@nhs.net 0044 1223 250874 Official trial record

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