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Using a drug combination to treat vaginal flora abnormalities in pregnant women at high risk of preterm birth.

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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 pregnant women who are at a high risk of preterm birth, which is a birth that occurs before 37 weeks of pregnancy. The research looks at individuals with vaginal flora abnormalities, meaning an imbalance in the natural bacteria found in the vagina, and Bacterial vaginosis, a common condition caused by an overgrowth of certain bacteria. The purpose of the study is to evaluate if using a new testing method to identify these imbalances early in pregnancy can help reduce the number of early births.

Participants may receive different treatments depending on their assigned group. Medications used in the study include clotrimazole, metronidazole, azithromycin, ceftriaxone, and doxycycline. Some treatments are taken by mouth as a tablet, while others are administered through an intramuscular injection, which is a shot given into a muscle, or as a vaginal capsule, which is a soft medication inserted into the vagina. Some participants may also receive a placebo instead of the active medication.

During the study, women will undergo screening to check for bacterial imbalances using molecular biology, a method used to look at the genetic material of bacteria to identify them. The course of the study involves monitoring the health of both the mother and the baby throughout the pregnancy and following the outcomes of the birth. This includes tracking various health factors such as the length of the pregnancy and any medical needs for the newborn.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    A vaginal swab, which is a sample taken from the vaginal area, is performed to check for vaginal flora abnormalities (imbalances in the natural bacteria in the vagina) using molecular biology (a method to identify specific genetic material from microorganisms).

  2. Step 2

    Assignment to a group

    Based on the screening results, assignment to one of two groups occurs: group a (the experimental group receiving the new screening and treatment strategy) or group b (the standard care group receiving usual medical management).

  3. Step 3

    Treatment in group a

    If vaginal flora abnormalities are detected in group a, specific medications are administered to treat the condition.

    Treatment may include mycohydralin 500 mg, which is a soft capsule used vaginally.

    Treatment may include flagyl 500 mg, which is a tablet taken orally (by mouth).

    Treatment may include zithromax 250 mg, which is a tablet taken orally.

    Treatment may include rocephine 1 g/3.5 ml, which is an intramuscular injection (a shot given into a muscle).

    Treatment may include granudoxy 200 mg, which is a tablet taken orally.

  4. Step 4

    Follow-up and monitoring

    For those in group a, vaginal samples are collected to perform molecular analysis to check the effectiveness of the treatment and to see if the bacteria return, which is known as recurrence.

    The pregnancy is monitored to track the rate of preterm birth (giving birth before 37 weeks of pregnancy) and other health outcomes for both the mother and the baby.

Who can join the trial?

7 criteria

  • You must be a woman who is at least 18 years old.
  • You must be pregnant with only one baby inside the womb.
  • Your pregnancy must be between 8 and 18 weeks of progress (gestation).
  • You may have bacterial vaginosis, which is an imbalance of the natural bacteria in the vagina, and you may have symptoms like unusual discharge or no symptoms at all.
  • You must have a history of preterm birth, which means giving birth before 37 weeks of pregnancy.
  • You may have a history of late miscarriage or fetal loss, which means losing a pregnancy between 14 and 22 weeks.
  • You must have social security or a similar type of health insurance coverage.

Who cannot join the trial?

13 criteria

  • Adult women who are under legal protection or guardianship, which means someone else makes legal decisions for them, or women who are currently deprived of liberty (in prison).
  • Women who have an allergy or hypersensitivity (an extreme reaction) to the medicine being used or any of its excipients (the inactive ingredients used to make the medicine).
  • Women experiencing an ectopic pregnancy, which is a pregnancy that grows outside the uterus, usually in a fallopian tube.
  • Women with a non-evolutive pregnancy or intrauterine fetal demise, which means the pregnancy is not developing normally or the baby has died inside the womb.
  • Women who have only had preterm births (births before 37 weeks) caused by preeclampsia (high blood pressure during pregnancy) or intrauterine growth restriction (when a baby does not grow at the expected rate inside the womb), but who have no other history of early birth or late miscarriage (loss of pregnancy later in the first or second trimester).
  • Women whose history of early birth or late miscarriage was caused specifically by a baby dying in the womb before labor or by a voluntary abortion (a planned termination of pregnancy).
  • Women who are nulliparous, which is a medical term for women who have never given birth to a baby.
  • Women who are having a multiple pregnancy, such as carrying twins, triplets, or more.
  • Women whose pregnancy screening shows a serious fetal malformation, which refers to major physical problems with the baby's development, such as issues with the heart, brain, spine, or abdominal wall.
  • Women with a uterine malformation, which means the uterus (womb) is shaped differently than normal, such as having only one horn or being divided by a wall.
  • Women whose history of early birth was specifically caused by a twin pregnancy.
  • Women who are currently taking part in, or plan to join, another clinical trial (a research study with humans) that might affect the natural bacteria in the vagina or the rate of early birth.
  • Women who have taken anti-infective treatment (medicine used to fight infections, like antibiotics) during the week before joining the study.
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Investigated drugs

  • Clotrimazole

    is a medication used as a vaginal capsule to treat infections caused by fungi.

  • Metronidazole

    is a pill taken by mouth to treat infections caused by certain types of bacteria or parasites.

  • Azithromycin

    is an antibiotic taken by mouth to treat various bacterial infections.

  • Ceftriaxone

    is an antibiotic given as an injection into the muscle to treat bacterial infections.

  • Doxycycline

    is an antibiotic taken by mouth to treat different types of bacterial infections.

What is already known about the treatment

  • Clotrimazole

    This medication is a soft capsule used for vaginal application to treat fungal infections. It is a widely used antifungal agent that works by damaging the protective outer layer of fungal cells, causing them to leak and die. It belongs to the imidazole class of medicines and is commonly prescribed for yeast infections.

  • Metronidazole

    This medicine is an oral film-coated tablet used to treat various bacterial and parasitic infections. It is a well-established antibiotic that works by interfering with the DNA of harmful microbes, preventing them from multiplying. It is classified as an antibiotic and is frequently used for infections like bacterial vaginosis.

  • Azithromycin

    This drug is administered as an oral film-coated tablet to treat several different types of bacterial infections. It is a commonly used antibiotic that works by stopping bacteria from producing the proteins they need to grow and function. It belongs to the macrolide group of medications.

  • Ceftriaxone

    This medication is provided as a powder and solvent for injection directly into a muscle. It is a powerful antibiotic used to treat serious bacterial infections by preventing bacteria from building their protective cell walls. It belongs to the cephalosporin class of drugs.

  • Lidocaine hydrochloride monohydrate

    This substance is included in an injectable solution to help reduce pain during the injection process. It acts as a local anesthetic by temporarily blocking nerve signals in a specific area of the body. It is classified as a local anesthetic.

  • Doxycycline

    This is an oral film-coated tablet used to treat a wide range of bacterial infections. It belongs to the tetracycline class of antibiotics and works by preventing bacteria from building the proteins necessary for survival. It is a standard treatment for various common infections.

Investigated diseases

Bacterial vaginosis - This condition occurs when there is an imbalance in the natural bacteria found in the vagina. It happens when certain types of harmful bacteria increase in number while helpful bacteria decrease. This change can lead to shifts in the local environment. The condition typically progresses through a change in the bacterial population within the vaginal canal. High risk preterm birth pregnancy - This refers to a pregnancy where there is an increased likelihood of the baby being born before 37 weeks of gestation. It often involves women with a history of delivering babies early or experiencing late pregnancy losses. The condition is characterized by specific medical history or physiological factors that may influence the timing of labor. It focuses on the potential for the pregnancy to reach full term. Vaginal flora abnormalities - This refers to a disruption in the normal community of microorganisms living in the vagina. It involves a change in the typical balance of beneficial and harmful microbes. These changes can manifest as an overgrowth of certain organisms or a depletion of healthy ones. The condition progresses as the microbial environment shifts away from its standard state.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509421-41-03Protocol codeAUTOP 2Estimated enrolment1 794 patientsSponsorAssistance Publique Hopitaux De Marseille

sourced from the EU Clinical Trials Register and site verification

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