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New device maps cervix stiffness to predict preterm birth risk

NCT ID NCT05858775

Knowledge-focused Sponsor: Pregnolia AG Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new device that measures cervix stiffness in pregnant women between 16 and 22 weeks. The goal was to see if stiffness differs at various spots on the cervix. Thirty women took part, and the results could help doctors better assess the risk of preterm birth in the future.

What this could mean

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

What this could lead to
If successful, this could lead to a more objective way to assess preterm birth risk during pregnancy.
What could go wrong
This is a small, early mapping study with only 30 participants. It does not test whether the device actually prevents preterm birth, so real-world benefits are uncertain.

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

30 people

The number who actually took part.

Started

Jul 2023

Finished

Oct 2025

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 women at gestational ages between 16+0 - 22+6 weeks

Ages

18 to 60 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 * Pregnant woman at GA 16+0 - 22+6 * Singleton pregnancy * 18 years or older * Nulliparous cohort: nulliparous pregnant woman * Multiparous cohort: multiparous pregnant woman Exclusion Criteria: * Lack of informed consent * Placenta praevia * Severe vaginal bleeding * Rupture of membranes before 34 weeks (to be excluded with pH test) * Visible tissue scarring at the measurement locations\* on cervix * Light bleeding (if the bleeding can be stopped, it is no longer an exclusion criterion) * Cervical dilation ≥ 3 cm * Cerclage or pessary in place * Vaginal or cervical infections (to be excluded with the Amsel criteria)

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As listed by the trial registrant

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

Cervix; pregnancy

Contacts and locations

Locations

  • University Hospital Zurich

    Zurich, Switzerland

  • gynosense AG

    Uster, Switzerland

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