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A 10-Minute swab test could tell who will deliver early

NCT ID NCT04374916

Diagnosis Sponsor: University Hospital, Strasbourg, France Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Aug 21, 2026

Summary

This trial tests whether a quick vaginal swab test, Premaquick, can better predict if a woman with threatened preterm labor will deliver within the next 7 days. It compares Premaquick to an existing test, Partosure, in 200 women with a single pregnancy between 24 and 33 weeks. The goal is to find a reliable way to identify who is truly at risk of early delivery, helping avoid unnecessary treatments and hospital stays.

What this could mean

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

Active substance
Premaquick® and Partosure® diagnostic tests
What this could lead to
If Premaquick proves accurate, it could give doctors a reliable, fast way to identify which women with threatened preterm labor will actually deliver early, reducing unnecessary hospital stays and interventions.
What could go wrong
This is a diagnostic accuracy study, not a treatment trial. The test may not perform better than existing methods, and results from this single-center study may not apply broadly. False positives or negatives remain possible.

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

About 200 people

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

Started

Aug 2020

Expected to finish

Sep 2026

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.

Inclusion Criteria: * Patient aged \> 18 years (with no upper age limit) * Patient affiliated to a social security health regime * Between 24 and 33 + 6 weeks of gestation (amenorrhea) * Singleton pregnancy * Patient with a TPL: Uterine contractions during the last 24 hours felt by the patient, painful or not, and cervix less than or equal to 25 mm on endovaginal ultrasound * Having signed an informed consent form Exclusion Criteria: * Twin pregnancy * Sexual intercourse less than 24 hours from inclusion * Cervical cerclage * Abundant metrorrhagia * Premature rupture of membranes * Pre-eclampsia * Congenital malformation * Presence of a placenta previa * Pelvic examination in the previous 24 hours (compared to inclusion) * Patient under guardianship, curatorship or safeguard of justice * Persons deprived of their liberty by judicial or administrative decision * Persons under psychiatric care under duress

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Preterm delivery Threatened preterm labor

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hôpitaux Universitaires de Strasbourg

    RECRUITING

    Strasbourg, 67091, France

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