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Comparison of ceftriaxone and azithromycin versus amoxicillin and azithromycin for pregnant women with preterm premature rupture of membranes between 22 and 33 weeks.

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on women experiencing Preterm Premature Rupture of Membranes, a condition where the protective sac around a developing baby breaks too early in pregnancy. The purpose of the study is to compare different antibiotic treatments to see which is more effective at preventing health problems for the baby and the mother. The medications being studied include ceftriaxone and azithromycin, which will be compared against a combination of amoxicillin and azithromycin.

Participants in the study will receive one of the two antibiotic regimens. One group will receive ceftriaxone through an intravenous, subcutaneous, or intramuscular method, which means the medicine is delivered via an injection into a vein, under the skin, or into a muscle. The other group will receive amoxicillin or azithromycin through oral use, meaning the medicine is taken by mouth. The study follows these patients to monitor the health of the baby and the mother during and after the pregnancy.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>medication administration</b>

    One of two antibiotic regimens will be administered to prevent infection following the preterm prelabor rupture of membranes, which is the premature breaking of the amniotic sac before 34 weeks of pregnancy.

    The first option consists of ceftriaxone, given at a dose of 1 gram through an intravenous (into a vein), subcutaneous (under the skin), or intramuscular (into the muscle) injection, combined with azithromycin, which is taken orally (by mouth) at a dose of 500 milligrams.

    The second option consists of amoxicillin, which is taken orally (by mouth) at a dose of 3 grams, combined with azithromycin, which is taken orally (by mouth) at a dose of 500 milligrams.

  2. Step 2

    <b>monitoring and outcomes</b>

    The progress of the pregnancy and the health of the newborn will be monitored to assess the duration of the pregnancy and any potential infections.

    Health outcomes for the newborn will be evaluated, including the need for mechanical ventilation (a machine to help with breathing), certain types of brain or lung complications, or infections such as sepsis.

    The development of the child will be tracked, including a psycho-motor development assessment (the ability to move and coordinate actions) via a questionnaire when the child reaches 2 years of age.

Who can join the trial?

10 criteria

  • You must be a woman who is 18 years of age or older.
  • You must be experiencing PPROM, which stands for Preterm Premature Rupture of Membranes (this is when the protective sac around the baby breaks too early, often called your "water breaking," before the baby is born).
  • The rupture of the protective sac must occur between 22 and 33 weeks of pregnancy.
  • The diagnosis must be confirmed by a medical team through a physical exam or laboratory tests.
  • You must be carrying a singleton gestation, which means you are pregnant with only one baby.
  • The fetus (the unborn baby) must be alive at the time you are assigned to the study.
  • You must be eligible to receive the standard antibiotic prophylaxis, which is a preventative medicine used to stop infections before they start.
  • You must be able to speak French.
  • You must be covered by the French social security system or a similar insurance system.
  • You must provide informed consent, which means you have been given all the facts about the study and have signed a document agreeing to participate.

Who cannot join the trial?

9 criteria

  • Having a suspected infection inside the womb at the time of diagnosis, which is defined as having preterm premature rupture of membranes (when the protective sac around the baby breaks too early) along with a fever (body temperature of 38°C or higher) and at least two of the following: a fast fetal heart rate (over 160 beats per minute for 10 minutes), uterine pain or contractions, or cloudy, pus-like fluid at the opening of the cervix.
  • Being currently treated with antibiotics (medicine used to fight infections) such as amoxicillin, third-generation cephalosporins (a specific group of antibiotics), or macrolides (another group of antibiotics) for 24 hours or longer at the time of joining the study.
  • The baby having a major physical abnormality or serious developmental issue.
  • Having an allergy or a medical reason why you cannot take any of the antibiotics used in this study.
  • Already taking part in another medical study that involves testing a new drug.
  • Having a mental state that makes it impossible to understand the study or to provide informed consent (giving your permission after fully understanding all the facts).
  • Being deprived of liberty, meaning being held in a facility by legal or government orders.
  • Being under guardianship or conservatorship, which means having a person legally appointed to make decisions for you.
  • Being a relative of the doctor or researcher who is enrolling you in the study.
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Investigated drugs

  • Ceftriaxone

    is an antibiotic used in this study to help prevent infections in pregnant women whose water has broken too early.

  • Amoxicillin

    is an antibiotic used as a comparison treatment to help prevent infections in pregnant women whose water has broken too early.

  • Azithromycin

    is an antibiotic that is used in combination with other antibiotics to help prevent infections in pregnant women whose water has broken too early.

What is already known about the treatment

  • Ceftriaxone

    This medication is an antibiotic administered through an injection into a vein, under the skin, or into a muscle. It is widely used in medical practice to treat various bacterial infections, including those that may occur during pregnancy complications. The drug works by preventing bacteria from building their protective cell walls, which ultimately causes the bacteria to die. It belongs to a group of medicines known as cephalosporins.

  • Amoxicillin

    This is an antibiotic that is taken by mouth in the form of a pill or liquid. It is a well-established treatment used to fight many common bacterial infections. The medication works by interfering with the ability of bacteria to create their outer cell walls, preventing them from growing and multiplying. It is classified as a penicillin-type antibiotic.

  • Azithromycin

    This antibiotic is taken orally to treat a variety of bacterial infections. It is a commonly prescribed medication in both hospital and home settings. At a molecular level, it works by entering the bacteria and stopping them from making the proteins they need to survive and function. It belongs to a class of drugs called macrolides.

Investigated diseases

Preterm premature rupture of membranes - This condition occurs when the protective sac surrounding a developing fetus breaks before labor begins. It typically happens during the second or third trimester of pregnancy. The rupture allows amniotic fluid to leak from the uterus through the vagina. This event can lead to an earlier onset of labor than expected. It may also expose the developing fetus to potential infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520842-31-00Protocol codeAPHP230841Estimated enrolment1 008 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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