AuthorisedTherapeutic confirmatory (Phase III)Interventional

Echec-MAT - A combination of antibiotics to improve neonatal mortality and morbidity for pregnancies complicated with previable labour and intact membranes: an open multiple center, randomized, and controlled trial

This research study, called Echec-MAT, is investigating if giving a combination of antibiotics to pregnant women can lead to better health for their babies. It focuses on women who are in hospital because they might go into labour too early, but their waters haven't broken yet. The antibiotics being tested are Ceftriaxone, Clarithromycin, and Metronidazole. The main goal is to see if these antibiotics can reduce serious problems for the baby, such as miscarriage, stillbirth, or severe health issues just after birth, before they leave the hospital. This is a large study (Phase III) to confirm if this treatment is effective.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

350

Start

19 Sep 2024

Pregnant women with singleton pregnancies hospitalized for threatened late miscarriage with intact membranes

What is this study about?

This study, called Echec-MAT, is designed for pregnant women who are unfortunately experiencing what doctors call 'threatened late miscarriage.' This means they are in hospital because there's a risk their baby might be born too early, but their amniotic sac (waters) is still intact. The researchers want to find out if using a specific combination of antibiotics can help to improve the health of these babies.

The medical team is testing three commonly used antibiotics together: Ceftriaxone, Clarithromycin, and Metronidazole. They want to see if this treatment can reduce the chances of serious problems for the baby. These problems could include losing the baby late in pregnancy, the baby being stillborn, or developing serious health issues shortly after birth before they go home from the hospital. Some examples of these serious issues include problems with their lungs, brain, or gut.

This is a 'Phase III' study, which means it's a large and important step in confirming if this antibiotic combination is truly effective and safe. By participating, women would be helping doctors understand if this treatment can make a real difference for babies born in these challenging circumstances.

Key takeaways

This study investigates if a specific antibiotic combination can help prevent serious problems for babies at risk of early birth.
It's for pregnant women with a single baby, in hospital for threatened early labour with unbroken waters.
The goal is to reduce late miscarriage, stillbirth, and severe health issues in newborns.
Participation involves receiving three antibiotics and regular health checks for you and your baby.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

This study is looking for pregnant women who are at least 18 years old. You must be carrying one baby, not twins or more, for this study.

To be considered, you need to be in hospital because there's a concern your baby might be born too early (known as threatened late miscarriage), but importantly, your waters (amniotic sac) must still be intact.

Your doctor will check other specific health details to make sure this study is right and safe for you to join.

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 only one baby?
Are you currently in hospital due to concerns about early labour?
Are your waters (amniotic sac) still intact and not broken?
Have your doctors indicated you have threatened late miscarriage?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given a combination of three antibiotics: Ceftriaxone, Clarithromycin, and Metronidazole. These will be given to you for a set period. You would continue to receive the standard care you would normally get for your condition. Doctors and nurses will regularly check on you and your baby's health. They will look for any changes and monitor for any potential side effects. There will be reviews and examinations to assess the baby's health both before and after birth, until they are discharged from the hospital. The total duration of your participation would depend on your individual situation and your baby's needs, up until your baby is discharged.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the antibiotic treatment might improve the health outcomes for your baby, reducing the risk of serious complications. However, there's no guarantee the treatment will work for you, and like all medicines, antibiotics can have side effects. These can range from mild to more serious and will be discussed in detail by your doctor. You are completely free to withdraw from the study at any time, for any reason, without it affecting the medical care you receive.

Locations (1)

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

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Unverified
France

Common questions

What is 'threatened late miscarriage'?

It means you're in hospital because there's a risk your baby might be born too early, usually between 14 and 23 weeks of pregnancy, but your waters haven't broken yet.

What are antibiotics and how do they work?

Antibiotics are medicines that fight infections caused by bacteria. In this study, they're being tested to see if they can help in early labour situations, possibly by treating or preventing certain infections that might contribute to early birth.

Will I know if I'm getting the antibiotics?

Yes, this is an 'open-label' study, which means you and your doctors will know that you are receiving the antibiotic combination being tested.

What kind of checks will my baby have?

Doctors will closely monitor your baby's health from birth until they leave the hospital, looking for conditions like lung problems, infections, or brain bleeds, using scans and other tests as needed.

Can I still receive my usual care if I join?

Absolutely. Joining this study means you'll receive the antibiotic treatment in addition to the standard medical care you would normally be given for your condition.