RecruitingNAINTERVENTIONAL

Pilot Study of Microvesicles in Pre-eclamptic and Non-pre-eclamptic Women With Threatened Preterm Delivery

This research is a pilot study investigating tiny particles found in blood, called microvesicles. Scientists think these microvesicles might play a role in pre-eclampsia, a serious blood pressure condition that can affect pregnant women. The main goal is to compare the amount and types of these microvesicles in the blood of women who have pre-eclampsia with those who don't. All participants in this study are women who have gone into labour early, but not necessarily with pre-eclampsia. By comparing these tiny particles, researchers hope to learn more about how pre-eclampsia develops and if these microvesicles could be an early sign or a way to understand the condition better in future.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

Start

31 May 2023

Estimated completion

01 Dec 2025

Pre-Eclampsia

What is this study about?

Imagine your body as a busy city, and your cells are like houses. Sometimes, these houses shed tiny fragments, almost like microscopic dust or debris. These tiny fragments are called microvesicles. Scientists are very interested in these microvesicles because they carry information from the cells they came from, like little messages.

In pregnant women, the placenta – the organ that connects the baby to the mother – also releases these microvesicles. Researchers believe that too many or specific types of these placenta-related microvesicles might be involved in pre-eclampsia. Pre-eclampsia is a serious condition in pregnancy that causes high blood pressure and can affect the mother's organs.

This study aims to carefully look at these microvesicles in the blood of women who have pre-eclampsia and compare them to women who don't. All the women taking part are also experiencing what's called 'threatened preterm delivery', meaning they are at risk of giving birth early. By doing this comparison, the researchers hope to find out if there are differences in these microvesicles that could help us understand pre-eclampsia better and potentially lead to new ways of detecting or treating it in the future.

Key takeaways

This study investigates tiny particles in blood called microvesicles.
It compares these particles in pregnant women with and without pre-eclampsia.
The goal is to better understand pre-eclampsia and how it develops.
Participation involves providing a single blood sample.
Your medical care will not be affected by taking part.
Your involvement could help future pregnant women.

Who may be eligible?

To join this study, women must be at least 18 years old and pregnant with one baby (or a twin pregnancy that naturally became a single baby before 14 weeks).

They need to be between 23 and 31 weeks and 6 days pregnant when they join. It's really important that participants understand what the study involves and are happy to take part. They also need to be covered by a social security system.

There are two groups in the study. If you don't have pre-eclampsia, you must be in hospital because you're at risk of giving birth early, and you shouldn't have any signs of infection (like a fever or high inflammation markers in your blood). If you do have pre-eclampsia, it must be a severe form that developed before 32 weeks of pregnancy. You can't join if you don't understand the study, refuse to give your permission, or are under legal protection.

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?
Are you pregnant with one baby (or was it a single baby by 14 weeks)?
Are you between 23 and 31 weeks and 6 days pregnant?
Do you understand the study and agree to take part?
Are you either in hospital for threatened early labour (without infection) OR have severe pre-eclampsia before 32 weeks?
Are you NOT under any legal protection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll be asked to do is provide a blood sample. This is similar to a routine blood test you might have at the doctor's office. There are no other visits, medications, or long-term follow-up appointments specifically for this research study beyond your usual pregnancy care. The total duration of your participation in this study is limited to the time it takes to collect your blood sample.

Potential risks and benefits

By taking part, you could be helping doctors learn more about pre-eclampsia, which might benefit future pregnant women. However, this study will not directly change your medical care. The main risk is the slight discomfort and potential bruising from having a blood sample taken, similar to any routine blood test. You are always free to change your mind and withdraw from the study at any time without affecting your medical care.

Locations (1)

CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What are microvesicles?

They are tiny particles released by cells, carrying messages or information from those cells. Researchers believe they might play a role in health conditions.

What is pre-eclampsia?

It's a serious condition that can happen in pregnancy, causing high blood pressure and affecting the mother's organs.

Will this study change my care?

No, taking part in this study will not change the medical care you receive for your pregnancy or any conditions you have.

What will I have to do if I join?

You will be asked to provide a blood sample, just like a standard blood test you might have during pregnancy.

Is the study just for women with pre-eclampsia?

No, the study includes both women with severe pre-eclampsia and women who are at risk of giving birth early but do not have pre-eclampsia.

How to find out more

Loic Sentilhes, MD, PhD

loic.sentilhes@chu-bordeaux.fr +335 57 82 23 36 Official trial record

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