A Combination of Antibiotics to Decrease Neonatal Morbidity and Mortality for Previable Threatened Labor
This study is testing if a special combination of antibiotics can help extend pregnancies in women who are at risk of giving birth much too early. This is for situations where the baby is not yet developed enough to survive well outside the womb, and the waters haven't broken. Doctors want to see if these antibiotics can prevent infections that might trigger early labour and allow babies more time to grow. If successful, this could significantly improve the health and survival chances of these very premature babies. The study is comparing the antibiotic treatment to usual care for this specific situation.
At a glance
What is this study about?
This study is looking into a very important issue: helping babies stay in the womb longer when there's a risk of extremely early premature birth. Sometimes, before 24 weeks of pregnancy, a woman might show signs that her body is preparing for labour, even though her waters haven't broken. At this stage, babies are very small and fragile, and being born so early can cause serious health problems or even be life-threatening.
Doctors believe that hidden infections, even if you don't feel sick, might sometimes trigger these early signs of labour. Past studies on giving antibiotics in these situations haven't always shown clear benefits. However, newer research suggests that a specific mix of antibiotics might be effective in stopping these infections and inflammation. This study wants to confirm if this new combination (which includes medicines like ceftriaxone, clarithromycin, and metronidazole) can actually help prolong these very early pregnancies.
The main goal is to give these tiny babies more time to develop inside their mothers. Even a few extra days or weeks can make a huge difference to a baby's survival chances and their long-term health. By preventing potential infections, the hope is to allow the pregnancy to continue closer to full term, improving the health outcomes for these vulnerable newborns.
Key takeaways
- This study investigates if specific antibiotics can extend very early pregnancies.
- It's for women at risk of extreme premature labour and whose waters haven't broken.
- The goal is to improve the health and survival of very premature babies.
- Participating involves taking antibiotics and having extra medical check-ups.
- You can discuss side effects and withdraw from the study at any time.
Who may be eligible?
This study is for pregnant women who are between 18 and 23 and a half weeks pregnant. You must be over 18 years old and speak French well enough to understand the study details. You need to be pregnant with one baby (not twins or more) and the baby must be alive when you join the study. Importantly, you should not be having regular, painful contractions.
To be considered for this study, an ultrasound scan needs to show that your cervix (the neck of your womb) is very short (10mm or less), or a doctor can see that your membranes (the sac around the baby) are bulging when they do an examination. Your waters must not have broken. You also cannot join if you have certain medical conditions or if taking the study antibiotics would be unsafe for you. You also cannot be currently taking other antibiotics for a different reason, or participating in another research 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.
- Are you between 18 and 23 and a half weeks pregnant?
- Are you pregnant with only one baby?
- Have your waters not broken yet?
- Do you currently not have regular, painful contractions?
- Are you over 18 years old?
What does participation involve?
If you choose to take part in this study, you would receive a specific combination of antibiotics including ceftriaxone, clarithromycin, and metronidazole. The study would involve regular check-ups and monitoring to see how you and your baby are doing. This includes physical examinations, potentially more ultrasound scans, and blood tests to track your health and the progress of your pregnancy. The exact number of visits and tests would be explained to you fully by the study team. You would be carefully followed up throughout your pregnancy and after the baby is born to see the long-term effects of the treatment for both you and your child. The total duration of your active participation, including follow-up for your baby, would be explained.
Potential risks and benefits
Locations (1)
- Centre Hospitalier Poissy-Saint GermainVerified postcodePoissy, France
Common questions
What does 'previable' mean?
It means the baby is too young in the pregnancy to survive well outside the womb, usually before 24 weeks.
What does 'intact membranes' mean?
It means your 'waters' (the fluid-filled sac around your baby) have not broken yet.
Are the antibiotics safe for my baby?
The study aims to check the safety and effectiveness. Your doctor will discuss the potential risks and benefits of these specific antibiotics with you.
What happens if I don't want to join the study?
That's perfectly fine. Your decision will not affect your medical care, and you will receive standard treatment for your condition.
How long will I take the antibiotics for?
The exact duration of the antibiotic treatment will be explained by the study team if you are eligible to join.
How to find out more
Thibaud QUIBEL, MD, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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