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Could a simple swab predict preterm delivery?

NCT ID NCT07307365

Diagnosis Sponsor: Rea Diagnostics SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new kit called PremaSure that uses a vaginal swab to predict if a pregnant woman with symptoms will deliver early. Researchers will check how accurate the test is by comparing its results to whether women give birth within 7 or 14 days. The goal is to see if women can use this test themselves to quickly know their risk.

What this could mean

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

Active substance
PremaSure diagnostic kit (vaginal swab test)
What this could lead to
If successful, this could give pregnant women a simple, reliable self-test to quickly know their risk of early delivery, helping them seek timely care.
What could go wrong
This is an early-stage diagnostic study, not a treatment. The test may not be accurate enough, and results may not apply to all populations or 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.

Participants

About 800 people

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

Started

Dec 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Pregnant patients with symptoms of premature delivery.

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: * Informed Consent signed by the subject * Female patients above 18 years * Gestational week from 22w+0 days to 35w+6 days * Symptoms of prematurity. Exclusion Criteria: * Subject lacking capacity to provide informed consent * Enrolment of the project leader, their family members, employees and other dependent persons * Patients with ruptured amniotic membranes or blood in their vaginal discharge * Patients with vaginal examination in the last 24 hours * Previous enrolment in the current study

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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

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

  • Centre Hospitalier Universtaire Vaudois (CHUV)

    RECRUITING

    Lausanne, Canton of Vaud, 1001, Switzerland

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