AuthorisedTherapeutic confirmatory (Phase III)Interventional

AUTOP 2 : Screen-and-treat strategy for vaginal flora abnormalities by molecular biology in pregnant women at high risk of preterm birth: A Multicentre, Randomized Study

This study, called AUTOP 2, is investigating whether a new approach to screening and treating vaginal infections can lower the risk of giving birth early (before 37 weeks of pregnancy) in women who are already at higher risk. Vaginal infections are common and can sometimes contribute to babies being born prematurely. Researchers will compare a new, innovative screening and treatment plan with the usual care women receive. The main goal is to see if this new strategy can help more women carry their pregnancies further, improving outcomes for both mothers and babies. It's a large study that will look at many women to gather reliable information.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Marseille

Enrolment target

1,794

Start

01 Apr 2026

Bacterial vaginosis, High risk preterm birth pregnancy, Vaginal flora abnormalities

What is this study about?

This study, named AUTOP 2, is looking at a common concern for expectant mothers: giving birth too early, also known as preterm birth. When a baby is born before 37 weeks of pregnancy, it can sometimes lead to health problems for the baby. We know that certain changes in the natural balance of bacteria in a woman's vagina, often called vaginal flora abnormalities or bacterial vaginosis, might increase the risk of preterm birth.

Researchers are trying to find out if regularly checking for and treating these vaginal issues in pregnant women who are already at a higher risk of preterm birth can make a difference. The study will compare two groups of women: one group will receive a new way of screening and treating these infections, and the other group will receive the standard care that is usually provided. By doing this, we can see if the new approach is more effective at preventing babies from being born too soon.

The main aim is to see if the new screening and treatment method reduces the number of babies born before 37 weeks. They will also look at other important things, like how many babies are born very early (e.g., before 28 or 32 weeks), if women experience issues like their waters breaking early, or if there are problems with the baby’s growth. The hope is to find better ways to support pregnant women and help ensure more babies are born healthy and full-term.

Key takeaways

Aims to reduce preterm birth (before 37 weeks).
Focuses on screening and treating vaginal infections in at-risk pregnant women.
Compares a new strategy with standard care.
Involves various medications if infections are found.
Could help improve pregnancy outcomes for mothers and babies.

Who may be eligible?

This study is looking for pregnant women who are at least 18 years old. You would be considered if you are at a higher risk of giving birth too early. This means the researchers are focusing on women who might particularly benefit from the study's interventions.

To be eligible, you must be a woman and able to provide your consent to take part in the study. The study does not specify an upper age limit, so any woman aged 18 or older can be considered if she meets the other criteria.

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 pregnant?
Are you 18 years old or older?
Have you been told you are at higher risk for giving birth early?
Are you able to agree to take part in a study?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to either the group receiving the new screening and treatment plan or the group receiving standard care. This will involve regular checks for vaginal infections using samples taken by your doctor. If an infection is found, you might receive medication, potentially including vaginal capsules or tablets like Mycohydralin, Flagyl, Zithromax, Rocephine injections, or Granudoxy tablets. The specific type and how you take it will depend on the infection and your assigned group. You will have regular appointments with the study team to monitor your pregnancy and the baby’s health. We don't have details on the exact number of visits or the total length of your involvement, but it will span your pregnancy until your baby is born, and potentially a follow-up period after birth.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of identifying and treating vaginal infections that might increase the risk of preterm birth, potentially leading to a healthier pregnancy and childbirth experience. However, there are potential risks associated with any medical treatment, including side effects from the medications used. There's also the chance the new screening method might not be more effective than current care. Your personal information will be kept private. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is 'preterm birth'?

Preterm birth is when a baby is born too early, specifically before 37 weeks of pregnancy.

What are 'vaginal flora abnormalities'?

This refers to an imbalance of bacteria in the vagina, which can sometimes be linked to health issues during pregnancy.

Will I know which treatment group I'm in?

This information isn't always shared during the study to keep the results unbiased. Your doctor can explain more about 'randomised studies'.

What kind of tests will be done?

You will likely have vaginal swabs to check for infections, alongside your regular pregnancy check-ups and scans.

Are the medications safe for pregnancy?

All medications used in the study are either commonly prescribed in pregnancy or are being investigated for their safety and effectiveness. Your doctor will discuss the details with you.