AuthorisedTherapeutic confirmatory (Phase III)Interventional

ANTIPROM - Comparison of two prophylactic antibiotic regimens in case of preterm prelabor rupture of membranes before 34 weeks of gestation: a randomized controlled trial

This research study, called ANTIPROM, is focused on pregnant women whose waters have broken too early – specifically between 22 and 33 weeks of pregnancy. When this happens, there's a higher risk of infection for both the mother and the baby, and the baby might be born prematurely. The study is comparing two different groups of antibiotics, including common ones like amoxicillin and azithromycin, to see which combination is more effective at preventing serious health issues for the baby, such as severe lung problems, brain injuries, or severe infections. Researchers also want to see how these antibiotics affect the length of the pregnancy and the health of the mother. It’s an important step to improve care for situations where waters break early.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

1,008

Start

28 Apr 2026

Population of study participants Pregnant women with PPROM at 22 to 33 weeks’ gestation

What is this study about?

When a pregnant woman's waters break too early, especially before 34 weeks, it's known as 'preterm prelabor rupture of membranes' (PPROM). This can be a worrying time because it increases the risk of infection for both the mother and the baby, and the baby might be born much earlier than expected. Doctors often give antibiotics to try and prevent these infections.

This study, called ANTIPROM, is a really important piece of research. It's looking at whether one combination of antibiotics works better than another in these situations. Researchers are comparing two different ways of giving antibiotics, which include medicines like Ceftriaxone, Amoxicillin, and Azithromycin. These are common antibiotics many people have heard of.

Ultimately, the goal is to find the safest and most effective way to protect babies from very serious problems that can sometimes happen when they're born too early or get an infection. These problems can include severe breathing difficulties, injuries to the brain, or serious infections after birth. The study also looks at how long the pregnancy lasts and the mother's health. By carefully comparing these antibiotic treatments, doctors hope to improve the care and outcomes for mothers and babies in this challenging situation.

Key takeaways

The study compares two antibiotic combinations for women whose waters break early.
It aims to reduce serious health problems for babies born prematurely.
Participants will be closely monitored by medical staff.
Follow-up checks on the baby's development will occur around age two.
The study is for pregnant women aged 18+ with waters broken between 22 and 33 weeks.

Who may be eligible?

This study is looking for pregnant women who are at least 18 years old. The most important part of who can join is that their waters have broken early, specifically when they are between 22 and 33 weeks pregnant. This condition is known as PPROM.

There might be other reasons why someone can't join the study, but the main criteria are being an adult woman experiencing this specific pregnancy complication. If you think this might apply to you, your doctor will be able to check all the details to see if you're a good fit.

Joining a study is always a personal choice, and your doctors will make sure you have all the information you need to decide.

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 18 years old or older?
Are you currently pregnant?
Have your waters broken prematurely?
Were you between 22 and 33 weeks pregnant when your waters broke?

Answer every question to see your result.

What does participation involve?

The study involves receiving one of two different combinations of antibiotics. These antibiotics are given to help prevent infections after your waters have broken early. While you are in the study, doctors will closely monitor your health and your baby's health to see how the treatment is working and to look for any side effects.

After your baby is born, the doctors will continue to check on their health. This will include looking for any specific health problems or infections that can sometimes affect babies born prematurely. For some parts of the study, there will also be follow-up checks on your baby's development when they are around two years old. This might involve you answering some questions about their progress. The overall duration of your direct participation will depend on how long your pregnancy continues and the initial follow-up for your baby, with a long-term check around age two.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, as you would receive antibiotics that aim to prevent serious complications for you and your baby, and you would be very closely monitored by medical professionals. This close monitoring could lead to early detection of any issues. However, like all medications, the antibiotics used in the study can have side effects, and there's always a small chance that the treatment might not work as well as hoped, or that other unexpected problems could arise. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

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 does 'waters broken early' mean?

It means the protective sac of fluid around your baby has broken before your pregnancy is full-term, specifically between 22 and 33 weeks in this study.

Why are antibiotics given?

Antibiotics are given to help prevent serious infections that can affect both the mother and the baby when the waters break early.

What kind of health problems are they looking for in the baby?

They are looking for serious issues like severe breathing difficulties, brain injuries, or severe infections that can unfortunately affect babies born very prematurely.

Will I know which antibiotic I'm getting?

Because this is a 'randomized' study, you will be assigned to one of the two antibiotic groups by chance, and you might not know which one you are specifically receiving.

Who is paying for this study?

The information provided doesn't state the specific funding body, but clinical trials are usually funded by research organisations, governments, or pharmaceutical companies.