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Is the Vaginal Microbiome and Metabolome Associated With Spontaneous Preterm Birth (sPTB) in Multiple Pregnancies?

This study aims to understand why some twin pregnancies result in babies being born too early. We know that being born prematurely can cause serious problems for babies. Currently, it's hard to predict early births in twin pregnancies, and there aren't many effective treatments. Every woman has tiny organisms (like bacteria) in their vagina. This research will look at these organisms in twin pregnancies, comparing them in women who have early births to those who carry their babies to full term. We'll collect vaginal swabs, blood samples, and measure the stiffness of the cervix (the neck of the womb). By doing this, we hope to discover which organisms might be linked to early births, helping doctors to better predict and prevent this in the future.

At a glance

What is this study about?

When a woman is pregnant with twins, there's a higher chance of the babies being born earlier than expected. This is called preterm birth. Sadly, being born very early can sometimes lead to serious health problems for babies, affecting their brain, lungs, and gut, which can result in lifelong disabilities. The earlier babies are born, the greater the risk of these problems. While doctors have some ways to predict early births in pregnancies with one baby, these methods don't seem to work as well for twin pregnancies, and at the moment, there aren't many treatments that can reliably stop twins from being born too soon.

Every woman has a collection of tiny living things, like bacteria and yeasts, in her vagina. These are completely normal. Recent research has shown that these tiny organisms can change during pregnancy and might be connected to when a woman goes into labour. However, all the previous research on this has only been done with pregnancies where there's just one baby. We want to find out if these vaginal organisms play a role in twin pregnancies.

In this study, we want to see if there are particular patterns of these vaginal organisms in twin pregnancies that deliver too early, compared to those that go to full term. We’ll also be looking at blood samples and measuring how 'stiff' the cervix (the neck of the womb) is, as these might also offer clues about preterm birth. By collecting all this information, we hope to understand more about why some twin pregnancies result in early births. Our ultimate goal is to find better ways to predict which twin pregnancies are at risk and, in the future, to develop new treatments to prevent early births in twins.

Key takeaways

  • This study focuses on preventing premature births in twin pregnancies.
  • It investigates the tiny organisms in the vagina and their link to early births.
  • Data from vaginal swabs, blood, and cervix stiffness will be collected.
  • The goal is to improve prediction and develop new treatments for early twin births.
  • Participation is voluntary and will not affect your current medical care.
  • This research aims to help future parents of twins.

Who may be eligible?

To join this study, you need to be at least 18 years old and currently pregnant with twins. It's important that you understand the study well enough to agree to take part.

You won't be able to join if there are known serious health problems with your babies, such as a major birth defect or an issue with their chromosomes. Also, if English is not your main language, you won't be able to join this particular study.

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.

  1. Are you 18 years old or older?
  2. Are you currently pregnant with twins?
  3. Do you feel you understand what the study is about?
  4. Are your babies known to have no serious health problems?
  5. Do you speak English?
Answer every question to see your result.

What does participation involve?

If you decide to take part, we will collect some samples from you at different points in your pregnancy. You would have vaginal swabs taken at around 16 weeks, again at 28 weeks, and then once more when your babies are born. We will also take blood samples and measure how stiff your cervix (the neck of your womb) is. These measurements are simple and safe. There are no medications involved in this study. The total duration of your participation will be from when you join (around 16 weeks pregnant) until after your babies are born, likely a few days after delivery.

Potential risks and benefits

Taking part in this study won't directly improve your pregnancy care or your babies' health during this pregnancy. However, the information we gather could help future parents of twins by leading to better ways to predict and prevent early births. The risks involved are minimal, mainly discomfort from the vaginal swabs or blood tests. You are free to change your mind and leave the study at any time, without giving a reason, and this will not affect your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Liverpool Women's NHS Foundation Trust
    Verified postcode
    Liverpool, United Kingdom

Common questions

What is 'preterm birth'?

Preterm birth means when a baby is born too early, before 37 weeks of pregnancy.

What are 'vaginal microbes'?

These are tiny living things like bacteria and yeast that normally live in the vagina. They are healthy and natural.

Will this study change my medical care?

No, this study is for research only and will not change the care you receive for your pregnancy.

Do I have to take part?

No, taking part is completely your choice. You can say no without it affecting your medical care.

What is the 'cervix' and why are you measuring its stiffness?

The cervix is the opening of the womb. We're measuring its stiffness because sometimes changes in stiffness can be linked to early birth.

How to find out more

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

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