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Blood and swab tests could predict preterm birth risk

NCT ID NCT04067908

What the study statuses mean

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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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 investigates whether new biomarkers found in blood and vaginal samples can help predict the risk of premature delivery in pregnant women showing signs of preterm labor. Researchers will collect extra blood and swab samples from women between 22 and 33 weeks of pregnancy who are experiencing contractions or cervical changes. The goal is to see if these markers can identify who will deliver before 37 weeks, especially before 34 weeks, to improve early detection and care.

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 simple test that helps doctors predict which women are at risk of premature delivery, allowing earlier interventions.
What could go wrong
This is an observational study, not a treatment trial. The biomarkers may not prove accurate enough for clinical use, and results may not apply to all pregnancies.

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

111 people

The number who actually took part.

Started

Jun 2011

Finished

Dec 2013

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 women over 18 years of age * Term from 22 to 33 and 6 amenorrhea weeks * Single or twin pregnancy * Emergency consultant, in participating centers, for a threat of premature labor defined by: Uterine contractions greater than or equal to 3 in 30 minutes Clinical modification of the cervix Ultrasound collar less than 25 mm * Free, informed and written consent, dated and signed by the patient and the investigator before any investigation required by the research. * Patient affiliated to a Social Security scheme. Exclusion Criteria: * Premature rupture of membranes * Placenta previa * Vaginal haemorrhage at the time of sampling * Uterine malformation * Strapping, open bite * History of strapping and or open bite * Conization * Fetal malformation * Associated vasorenal pathology * Sexual intercourse less than 24h * Gynecological examination less than 48h * Vaginal treatment in progress * Polyhydramnios * Transfused-transfused syndrome * Twin Anemia Polycythemia syndrome * Fetoscopy during pregnancy

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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.

More trials for these conditions

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