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

NCT ID NCT06349122

Not yet recruiting Prevention Sponsor: Assistance Publique Hopitaux De Marseille Source: ClinicalTrials.gov ↗

First seen Aug 03, 2026 · Last updated Aug 04, 2026 · Updated 1 time

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.

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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.

BACTERIAL VAGINOSIS PREMATURE DELIVERY VAGINAL DYSBIOSIS

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