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Can a simple Self-Test cut preterm births in High-Risk pregnancies?

NCT ID NCT06349122

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 03, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This trial tests whether a self-administered vaginal swab, analyzed with advanced molecular technology, can detect and treat bacterial imbalances early in pregnancy. Pregnant women at high risk of preterm birth will either receive this screening plus targeted antibiotics or standard care. The goal is to see if this approach reduces the rate of preterm birth before 37 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Molecular screening test for vaginal flora abnormalities, followed by targeted antibiotic treatment (e.g., azithromycin) if an infection is found
What this could lead to
If effective, this approach could offer a simple, at-home screening method to identify and treat vaginal infections early, potentially reducing preterm births and improving newborn health.
What could go wrong
The trial is large but still experimental; the screening may not catch all infections, and antibiotics may have side effects. Results may not apply to all pregnant women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,794 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* Pregnant woman over 18 years of age; * Single intra uterine pregnancy after 8 weeks and before 18 weeks of gestation (i.e. ≥ 8 weeks and ≤ 18 weeks). Woman can present symptomatic vaginal discharge, or can be asymptomatic or symptomatic with regard to the diagnosis of bacterial vaginosis (BV) with usual technics; * With a history of : * preterm birth before 37 weeks of gestation (even if the preterm birth was following preterm rupture of membranes); * and / or late miscarriage or fetal loss (i.e. miscarriage or foetal loss between 14 and 22 weeks of gestation), even if one any of her last birth occurred at term. * Woman having a reliable connexion by phone * Woman who has understood the study process and objectives and agreed to sign an informed consent form; * affiliated to a social security regimen or equivalent. Any eligible woman who will agree to participate in the study after being invited must sign a consent form before being included in the study. Women meeting all of these eligibility criteria will be invited even if they have oral or vaginal progestative treatment, cerclage or pessary, partially septate or arcuate uterus. Exclusion Criteria: * \- Woman of legal age under legal protection; * Women deprived of their freedom for administrative or legal reasons; * Woman who has not signed a consent form * Nulliparous; * Ectopic pregnancy; * Non-evolutive pregnancy or IUFD * Multiple pregnancy * Serious fetal malformation identified at first trimester screening such as cardiopathy, exencephaly, anasarque, gastroschisis, omphalocele, diaphragmatic hernia, cerebral or spinal major anomaly. * Woman participating in any clinical trial or intent to participate in another clinical trial, which may have an impact on flora or on prematurity rate, with or without investigational product at any time during the conduct of this study * Woman presenting contraindications to the study treatments: Hypersensitivity to the active substance or to any of the excipients * Woman presenting uterine malformation ( unicornuate, bicornuate, full septate) * Woman with preterm birth history because of twin pregnancy * Woman having received anti-infective treatment in the week preceding inclusion

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Conditions

The condition(s) this trial relates to.

bacterial vaginosis Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.