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New test may improve preterm birth prediction

NCT ID NCT03608995

Diagnosis Sponsor: University Hospital, Clermont-Ferrand 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new combination test called Premaquick, which measures three markers in vaginal fluid, to see if it can better predict whether a woman with threatened preterm labor will deliver within 7 days. Researchers compared it to the standard fetal fibronectin test in 221 pregnant women. The goal is to improve accuracy and help doctors make better decisions about care.

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

221 people

The number who actually took part.

Started

Aug 2018

Finished

Dec 2020

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: * Major pregnant women admitted to Clermont-Ferrand CHU maternity for threatened preterm delivery with intact membranes between 24 and 34 (+6 days) week of amenorrhea, with length of cervix \< 30mm (ultrasound measurement). * Ability to give informed consent. * French social security scheme. Exclusion Criteria: * \- Dilation of the cervix ≥ 4 cm * Triple pregnancy or more * Fetal membranes rupture * Known uterine malformation * Hydramnios * Fetal malformation * Placenta previa * Abundant metrorrhagia * Patient who had already participated in the study during the same pregnancy * Patient under guardianship or curatorship

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Conditions

The condition(s) this trial relates to.

Obstetric Labor, Premature Premature Birth

As listed by the trial registrant

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

Biomarkers Immunochromatographic assay Predictive value of tests Preterm delivery Preterm labor

Contacts and locations

Locations

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

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