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Quick swab test could prevent newborn sepsis

NCT ID NCT03371056

Diagnosis Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new rapid test (InSPIRe kit) that uses a simple vaginal swab to detect bacteria and infection markers in pregnant women. The goal is to quickly identify women who might pass harmful bacteria to their babies during birth, so doctors can prevent newborn infections. Over 2,500 pregnant women took part, and the test was compared to standard lab methods.

What this could mean

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

Active substance
InSPIRe kit (rapid diagnostic test)
What this could lead to
If successful, this test could help doctors quickly identify pregnant women carrying harmful bacteria, allowing early treatment to prevent infections in newborns.
What could go wrong
This is a completed study validating a diagnostic tool, not a treatment. The test may not be widely adopted or may not improve outcomes in real-world settings.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2,569 people

The number who actually took part.

Started

Aug 2018

Finished

Dec 2023

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.

Inclusion Criteria: * Pregnant woman, * Gestational age over 22 SA, * Patient agreeing to sign informed consent, * Patient aged at least 18 years old, * Patient with health insurance, * Singleton, twin or multiple pregnancy. Exclusion Criteria: * Fetal death or non-viable fetus, * maternal age under 18, * Patient unable to express her consent, * Patient under guardianship.

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As listed by the trial registrant

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

Neonatal infection

Contacts and locations

Locations

  • Hopital Bichat

    Paris, 75018, France

  • Hopital Louis Mourier

    Colombes, 92700, France

  • Hôpital Cochin

    Paris, 75014, France

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