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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopitaux Universitaires Paris Centre-Hopital Cochin Paris France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France
Hopital Necker Enfants Malades Paris France

Other Sites

Site Name City Country Status
Hopital Antoine Beclere Clamart France
Robert Debre University Hospital Paris France
Assistance Publique Hopitaux De Paris Paris France
Centre Hospitalier Universitaire De Rennes Rennes France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
Assistance Publique Hopitaux De Paris Creteil France
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Gnagsc Hyelxtfrrhs Uyhtcctmbdjvk Pnjza Purnoyakeob Ex Nxdlwizvezzt Paris France
Idlciwun ds Czecxwrsycul Hqfshmmxwzk Uukzngdvjpflp di Subhz Ercdarh (qbwwdqw Saint Priest En Jarez France
Hscpgsxl Uuohbnxmcupnjx Siklshombs &qyiqly Hqcgdiu dn Hsaxxiwleed STRASBOURG, Alsace France
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.07.2026

Trial locations

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.

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 ID:
2025-520842-31-00
Protocol code:
APHP230841
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on Antibiotic Combination of Ceftriaxone, Clarithromycin, and Metronidazole for Pregnant Women with Threatened Miscarriage and Intact Membranes

    Not yet recruiting

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    France