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

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 clinical trial is focused on improving outcomes for pregnancies that are at risk of a late miscarriage, which is when a pregnancy ends unexpectedly between 18 and 24 weeks. The study involves pregnant women who are experiencing signs of a possible miscarriage but still have intact membranes, meaning the protective sac around the baby has not broken. The goal is to reduce the risk of losing the baby and to improve the health of newborns by extending the pregnancy as long as possible.

The trial will test a combination of antibiotics to see if they can help achieve this goal. The medications being studied include CEFTRIAXONE, which is given as an injection, CLARITHROMYCIN, and METRONIDAZOLE, both of which are taken as tablets. These antibiotics are commonly used to treat infections and may help in preventing complications that could lead to a miscarriage or affect the baby's health.

Participants in the study will be randomly assigned to receive either the combination of antibiotics or a placebo. The study will monitor the health of the mother and baby throughout the pregnancy and after birth to assess the effectiveness of the treatment. The trial aims to provide valuable information that could lead to better care for pregnancies at risk of late miscarriage.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is confirmed to meet the inclusion criteria, which include being pregnant with a single fetus, having a threatened late miscarriage with intact membranes between 18 and 23 weeks of gestation, and other specified conditions.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to confirm the absence of regular and painful uterine contractions and to ensure the patient understands the study requirements.

  3. Step 3

    Medication administration

    The patient receives a combination of antibiotics to help prolong the pregnancy and improve outcomes for the baby.

    The medications include ceftriaxone sodium administered as a solution for injection, clarithromycin taken orally as a 500 mg film-coated tablet, and metronidazole also taken orally as a 500 mg film-coated tablet.

    The specific dosage and frequency of administration are determined by the study protocol and the healthcare provider.

  4. Step 4

    Ongoing monitoring

    Throughout the trial, the patient's health and the pregnancy are closely monitored to assess the effectiveness of the treatment and to identify any potential side effects or complications.

  5. Step 5

    Completion of the trial

    The trial continues until the estimated end date in March 2028, or until the patient completes the study requirements.

    The primary goal is to reduce neonatal mortality and severe health issues by prolonging the pregnancy.

Who can join the trial?

9 criteria

  • The patient must be a pregnant woman with a single baby (not twins or more).
  • The pregnancy should be between 18 weeks and 23 weeks and 6 days.
  • The patient must have a condition called **threatened late miscarriage**. This means there is a risk of losing the baby late in the pregnancy, but the **membranes** (the protective layers around the baby) are still intact.
  • This condition is identified by an ultrasound showing a **cervix** (the lower part of the uterus) that is 10 millimeters or less, or by seeing the **amniotic sac** (the fluid-filled sac around the baby) protruding when examined with a speculum (a tool used to look inside the body).
  • The baby must be alive at the time of joining the study.
  • The patient must be over 18 years old.
  • The patient should not have regular and painful contractions of the uterus.
  • The patient must understand the French language well enough to follow instructions and information about the study.
  • The patient must be affiliated with social security.

Who cannot join the trial?

6 criteria

  • Women who are not pregnant cannot participate.
  • Women who are not experiencing a threatened late miscarriage cannot participate. A threatened late miscarriage means there are signs that a miscarriage might happen later in the pregnancy.
  • Women who do not have intact membranes cannot participate. Intact membranes mean that the protective sac around the baby is not broken.
  • Women who are not hospitalized for this condition cannot participate.
  • Men cannot participate in this study.
  • Women who are pregnant with more than one baby (not a singleton pregnancy) cannot participate. A singleton pregnancy means there is only one baby.
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Investigated drugs

Antibiotics are used in this trial to help improve the health outcomes for newborns. The goal is to reduce the risk of death and serious health problems in babies by extending pregnancies that are at risk of ending too early. The antibiotics are given to pregnant women who are experiencing signs of labor but still have intact membranes, meaning their water has not broken yet. The use of antibiotics aims to prevent infections that could lead to early delivery and complications for the baby.

What is already known about the treatment

Antibiotic Combination – This medication is administered orally or intravenously, depending on the specific antibiotics used in the combination. It is currently being studied in clinical trials to assess its effectiveness in reducing neonatal mortality and morbidity in pregnancies threatened by late miscarriage with intact membranes. The main therapeutic indication is to prolong pregnancy in such cases, potentially improving outcomes for both the mother and the baby. At the molecular level, antibiotics work by targeting and inhibiting bacterial growth, which may help prevent infections that could complicate pregnancy. This combination falls under the pharmacological classification of antibiotics, which are substances used to treat bacterial infections.

Investigated diseases

  • Late Miscarriage

    Late miscarriage refers to the loss of a pregnancy after the first trimester but before the 20th week. It can occur due to various reasons, including infections, anatomical issues, or genetic factors. Symptoms may include vaginal bleeding, cramping, and the passing of tissue. The progression involves the onset of symptoms leading to the loss of the fetus. It is a distressing event for expectant mothers and requires medical attention to manage symptoms and prevent complications.

  • Perinatal Mortality

    Perinatal mortality encompasses the death of a fetus or neonate and is the basis for the perinatal mortality rate. It includes stillbirths and deaths within the first week of life. Causes can be related to complications during pregnancy, labor, or delivery, as well as congenital anomalies. The progression involves the occurrence of fatal events either before or shortly after birth. It is a critical indicator of maternal and infant health.

  • Bronchopulmonary Dysplasia

    Bronchopulmonary dysplasia is a chronic lung disorder that primarily affects premature infants who have received oxygen therapy. It is characterized by inflammation and scarring in the lungs. The condition develops over time as a result of lung injury and healing processes. Infants may experience difficulty breathing and require prolonged respiratory support. The severity can vary, with some infants recovering fully while others may have long-term respiratory issues.

  • Sepsis

    Sepsis is a life-threatening condition that arises when the body's response to infection causes injury to its own tissues and organs. It can progress rapidly, starting with symptoms like fever, increased heart rate, and confusion. If not managed, it can lead to severe complications, including organ failure. The condition is diagnosed through clinical signs and confirmed by a positive blood culture. Early recognition and treatment are crucial to prevent progression.

  • Intraventricular Hemorrhage

    Intraventricular hemorrhage is bleeding into the brain's ventricular system, primarily affecting premature infants. It is graded based on severity, with Grade 3 indicating more extensive bleeding. The condition can lead to increased pressure in the brain and potential damage to brain tissue. Symptoms may include apnea, bradycardia, and changes in muscle tone. The progression depends on the severity and can result in long-term neurological issues.

  • Periventricular Leukomalacia

    Periventricular leukomalacia is a type of brain injury that affects the white matter near the brain's ventricles. It is most common in premature infants and is associated with a lack of blood flow or oxygen to the brain. The condition can lead to the development of cysts and damage to brain tissue. Symptoms may not be immediately apparent but can include developmental delays and motor impairments. The progression and impact vary based on the extent of the injury.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-505500-37-00Protocol codeAPHP220670Estimated enrolment350 patientsSponsorAssistance Publique Hopitaux De Paris

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