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Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (ESBL)-Producing Enterobacteria in Preterm Premature Rupture of Membranes : A French Multicenter Cohort Study

This study is investigating a type of bug (germ) that can be hard to treat with common antibiotics, called ESBL-producing Enterobacteria. We're looking at how often these bugs are found in pregnant women whose waters break too early, before their due date. Doctors want to understand how often these bugs are present, how long they might stay, and what things might make a woman more likely to carry them. This information is really important. It will help doctors decide on the best antibiotics to give to mothers and their babies to prevent and treat infections, both during pregnancy and after the baby is born. The study will follow women from when their waters break until they give birth, by regularly taking samples to see how the bacteria change over time.

At a glance

Status
Not yet recruiting
Sponsor
Centre Hospitalier de Saint-Denis
Enrolment target
250
Start
01 Oct 2025
Estimated completion
15 Dec 2026

What is this study about?

This research study is focusing on a particular type of bacteria, often called 'bugs' or 'germs', which can be found in our bodies. These specific bugs are tricky because they've learned to resist many common antibiotics. They are called 'ESBL-producing Enterobacteria'. Doctors want to understand how often pregnant women carry these resistant bugs, especially if their waters break too early (this is known as premature rupture of membranes, or PPROM).

The main goal is to find out how many women with PPROM have these resistant bacteria, and how long they might carry them. We also want to identify any factors that might increase a woman's chances of having these bugs. This information is really valuable because if doctors know more about these resistant bacteria, they can make better choices about which antibiotics to use. This helps to protect both the mother and her baby from infections that could be hard to treat, both during pregnancy and after birth.

To do this, the study will involve women from the time their waters break until their baby is born. During this period, samples will be taken regularly. These samples will help researchers track whether these specific bugs are present and how they might change over time. The study is being carried out in several hospitals across France, pooling knowledge to get a clearer picture of this important health issue.

Key takeaways

  • The study investigates antibiotic-resistant bacteria in pregnant women.
  • It focuses on women whose waters break early (premature rupture of membranes).
  • Aims to improve choices for antibiotic treatment in mums and babies.
  • Involves tracking bacteria using samples collected during usual care.
  • Participation will not involve new treatments or procedures.

Who may be eligible?

This study is looking for pregnant women who are at least 18 years old. You might be able to join if your waters have broken early, specifically between 23 weeks and 36 weeks and 6 days of pregnancy. You would also need to be receiving care at one of the hospitals taking part in the study.

There are some reasons why you wouldn't be able to join. For example, if it's not possible to collect the necessary samples for the study. Also, if you are under 18 years old or under legal guardianship, you won't be able to take part. Finally, if you would prefer your health information not to be used for research purposes, you can choose not to participate.

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. Have your waters broken between 23 and nearly 37 weeks of pregnancy?
  3. Are you receiving care at a hospital participating in this study?
  4. Are you happy for your medical information to be used for research?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the main involvement will be allowing doctors to collect samples from you regularly, starting from when your waters break until your baby is born. These samples will be similar to those you might already have taken as part of your routine care. The purpose of collecting these samples is to check for the presence of specific bacteria. There are no new medications or extra hospital visits directly because of this study. The study aims to gather information from your usual care pathway to understand the bacteria better.

Potential risks and benefits

The potential benefits of taking part include contributing to important medical knowledge that could improve care for future pregnant women and their babies. There are very few direct risks to you, as the study mainly uses information and samples collected as part of your normal medical care. You always have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (1)

  • Centre Hospitalier de Saint-Denis
    Verified postcode
    Saint-Denis, France

Common questions

What are ESBL-producing Enterobacteria?

These are types of germs (bacteria) that can be difficult to treat with many common antibiotics because they have become resistant to them.

Why is this study important for me?

While it won't change your direct care, the information gathered will help doctors in the future choose the best antibiotics for mums and babies when waters break early.

Will taking part mean extra tests?

The study mostly uses samples that would be collected as part of your usual medical care, so there shouldn't be extra discomfort or procedures just for the study.

What happens to my information?

Your medical information will be used for research to understand these bacteria better. It will be kept private.

Can I leave the study at any time?

Yes, you are completely free to withdraw from the study at any point, and your medical care will not be affected.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Prevalence of Carriage of Extended-Spectrum Beta-Lactamase (…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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